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A Study to Determine Safety and Efficacy of Dolutegravir/Abacavir/Lamivudine (DTG/ABC/3TC) in Human Immunodeficiency Virus (HIV)-1 Infected Antiretroviral Therapy (ART) Naïve Women (ARIA)

Primary Purpose

Infection, Human Immunodeficiency Virus, HIV Infections

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Dolutegravir/abacavir/lamivudine FDC

Atazanavir

Ritonavir

Tenofovir/emtricitabine FDC

About this trial

This is an interventional treatment trial for Infection, Human Immunodeficiency Virus focused on measuring antiretroviral therapy naïve, women, once daily, HIV infection, atazanavir, tenofovir/emtricitabine, dolutegravir/abacavir/lamivudine fixed dose combination, integrase inhibitor, ritonavir

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

HIV-1 infected females (gender at birth) >=18 years of age
Women capable of becoming pregnant must use appropriate contraception during the study (as defined by the protocol)
HIV-1 infection as documented by Screening plasma HIV-1 RNA >=500 c/mL.
Documentation that the subject is negative for the HLA-B*5701 allele.
Antiretroviral-naïve (<=10 days of prior therapy with any antiretroviral agent following a diagnosis of HIV-1 infection).
Signed and dated written informed consent is obtained from the subject or the subject's legal representative prior to screening.

Exclusion Criteria:

Women who are pregnant or breastfeeding
Women who plan to become pregnant during the first 48 weeks of the study
Any subject who has had a medical intervention for gender reassignment
Any evidence of an active Centers for Disease Control and Prevention (CDC) Category C disease
Subjects with any degree of hepatic impairment
Subjects positive for hepatitis B at Screening, or anticipated need for HCV therapy during the study
History or presence of allergy to the study drugs or their components or drugs of their class
Ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma, or cervical intraepithelial neoplasia
poses a significant suicidality risk
History of osteoporosis with fracture or requiring pharmacologic therapy
Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening
Treatment with any of the following agents within 28 days of Screening: radiation therapy; cytotoxic chemotherapeutic agents; any immunomodulators that alter immune responses;
Treatment with any agent, with documented activity against HIV-1 in vitro within 28 days of first dose of investigational product (IP)
Exposure to an experimental drug or experimental vaccine within either 28 days, 5 half-lives of the test agent, or twice the duration of the biological effect of the test agent, whichever is longer, prior to the first dose of IP
Any evidence of primary viral resistance based on the presence of any major resistance-associated mutation in the Screening result or, if known, any historical resistance test result
Any verified Grade 4 laboratory abnormality, with the exception of Grade 4 lipid abnormalities (total cholesterol, triglycerides, High Density Lipoprotein (HDL) cholesterol, Low Density Lipoprotein (LDL) cholesterol)
Any acute laboratory abnormality at Screening, which, in the opinion of the Investigator, would preclude the subject's participation in the study of an investigational compound
Alanine aminotransferase (ALT) ≥5 times the upper limit of normal (ULN), or ALT ≥ 3xULN and bilirubin ≥ 1.5xULN (with >35% direct bilirubin)
Subject has CrCL of <50 mL/min via Cockroft-Gault method
Corrected QT interval (QTc (Bazett)) ≥450msec or QTc (Bazett) ≥480msec for subjects with bundle branch block.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

DTG/ABC/3TC FDC

ATV +RTV +TDF/FTC FDC

Arm Description

As per the randomization schedule subjects will be administered with DTG/ABC/3TC (50mg/600mg/300mg) FDC tablet OD up to Week 48 and if continued if applicable in the Continuation Phase. DTG/ABC/3TC FDC may be administered with or without food

As per the randomization schedule subjects will be administered with ATV (300mg capsule) +RTV (100mg tablet) + TDF/FTC (300mg/200mg tablet) FDC OD up to Week 48. ATV+RTV+ TDF/FTC FDC must be taken with food

Outcomes

Primary Outcome Measures

Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48

Percentage of participants with plasma human immunodeficiency virus type 1(HIV-1) ribonucleic acid (RNA) <50 copies per milliliter (c/mL) were assessed at Week 48 using the Snapshot algorithm. Analysis was performed using a stratified analysis with Cochran-Mantel-Haenszel (CMH) weights, adjusting for Baseline plasma HIV-1 RNA ( =<vs. >100,000 c/mL) and CD4+ cell count (=<350 cells per millimeter cube (cells/mm^3) or >350 cells/mm^3). Intent-to-Treat Exposed (ITT-E) Population comprised of all randomized participants who received at least one dose of study medication. Percentage values are rounded off.

Secondary Outcome Measures

Percentage of Participants With Plasma HIV-1 RNA <50 and <400 c/mL Over Time-Randomized Phase

Percentage of participants with plasma HIV-1 RNA <50 and <400 c/mL were assessed at Baseline, Weeks 4, 12, 24 , 36 and 48 using the Snapshot algorithm (Missing, Switch or Discontinuation = Failure). The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Percentage values are rounded off.

Percentage of Participants With Plasma HIV-1 RNA <50 c/mL in Continuation Phase

Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with plasma HIV-1 RNA <50 c/mL were reported. Percentage values are rounded off.

Change From Baseline in Plasma HIV-1 RNA at Indicated Time Points-Randomized Phase

Change from the Baseline in plasma HIV-1 RNA were assessed at indicated time points. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.

Change From Baseline in Plasma HIV-1 RNA at Indicated Time Points-Continuation Phase

Absolute Values in Plasma HIV-1 RNA at Indicated Time Points-Randomized Phase

Absolute Values in plasma HIV-1 RNA were assessed at indicated time points. The Baseline value was defined as the latest pre-dose assessment (Day 1) value.

Absolute Values in Plasma HIV-1 RNA at Indicated Time Points-Continuation Phase

Absolute Values in plasma HIV-1 RNA were assessed at indicated time points.

Change From Baseline in CD4+ Cell Count at Indicated Timepoints-Randomized Phase

Change from Baseline in cluster of differentiation 4 (CD4+) cell count were assessed at indicated time points. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.

Change From Baseline in CD4+ Cell Count at Indicated Timepoints-Continuation Phase

Change from Baseline in cluster of differentiation 4(CD4+) cell count were assessed at indicated time points. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.

Absolute Values in CD4+ Cell Count at Indicated Timepoints-Randomized Phase

Absolute values in CD4+ cell count were assessed at indicated time points. The Baseline value was defined as the latest pre-dose assessment (Day 1) value.

Absolute Values in CD4+ Cell Count at Indicated Timepoints-Continuation Phase

Absolute values in CD4+ cell count were assessed at indicated time points.

Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points

Clinical chemistry parameters were assessed at Baseline (Day 1), Weeks 4, 12, 24, 36 and 48. Change from Baseline in carbon dioxide, electrolytes (chloride, hyperkalemia, hypernatremia, hypokalemia, hyponatremia, phosphate, potassium, sodium), lipids (cholesterol [CHLS], high density lipoprotein [HDL] CHLS direct, low density lipoprotein (LDL) CHLS calculation, LDL CHLS direct, triglycerides), glucose (hyperglycaemia, hypoglycaemia) and urea are summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Laboratory parameters were assessed in Safety Population which comprised of all participants who received at least one dose of study treatment.

Change From Baseline in Bilirubin and Creatinine at Indicated Timepoints

Clinical chemistry parameters were assessed at Baseline (Day 1), Weeks 4, 12, 24, 36 and 48. Change from Baseline in bilirubin and creatinine are summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.

Change From Baseline in Albumin at Indicated Timepoints

Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in albumin is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.

Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase at Indicated Time Points

Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, creatine kinase is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.

Change From Baseline in Creatinine Clearance at Indicated Time Points

Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in creatinine clearance is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.

Change From Baseline in Lipase at Indicated Timepoints

Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in lipase is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.

Change From Baseline in Total CHLS/HDL CHLS Ratio at Indicated Timepoints

Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in Total CHLS/HDL CHLS ratio is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.

Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes at Indicated Time Points

Hematology parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in basophils, eosinophils, lymphocytes, monocytes is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.

Change From Baseline in Erythrocytes at Indicated Time Points

Hematology parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in erythrocytes is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.

Change From Baseline in Hematocrit Count at Indicated Time Points

Hematology parameters were assessed at Baseline (Day 1), Weeks 4, 12, 24, 36 and 48. Change from Baseline in hematocrit is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.

Change From Baseline in Erythrocyte Mean Corpuscular Volume at Indicated Time Points

Hematology parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in erythrocyte mean corpuscular volume (EMCV) is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.

Change From Baseline in Triglycerides at Week 48

Change from Baseline in mean triglycerides is summarized at Week 48. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Adjusted mean is the estimated mean change from Baseline in fasted triglycerides at Week 48 in each arm calculated from a model adjusted for the following covariates: treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, age and triglycerides at Baseline. Participants on lipid lowering therapy at Baseline were excluded from analysis. Measurements collected after a participant initiates lipid lowering therapy were set to missing. Missing values were imputed using multiple imputation under a multivariate normal model adjusting for Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, fasted triglycerides and TC/HDL ratio at Baseline, Week 12 and Week 36.

Change From Baseline in TC/HDL Ratio at Week 48

Change from Baseline in mean total cholesterol (TC)/HDL ratio is summarized at Week 48. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Adjusted mean is the estimated mean change from Baseline in fasted TC/HDL at Week 48 in each arm calculated from a model adjusted for the following covariates: treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, age and triglycerides/HDL at Baseline. Participants on lipid lowering therapy at Baseline were excluded from analysis. Measurements collected after a participant initiates lipid lowering therapy were set to missing. Missing values were imputed using multiple imputation under a multivariate normal model adjusting for Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, fasted triglycerides and TC/HDL ratio at Baseline, Week 12 and Week 36.

Change From Baseline in Urine Albumin Creatinine Ratio at Indicated Time Points

Change from Baseline in urine albumin creatinine ratio at Week 24 and Week 48 is summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.

Number of Participants With AEs by Maximum Toxicity-Randomized Phase

Number of participants with Grade 1-4 AEs by maximum toxicity were assessed from the start of study treatment and until end of the Randomization phase. AEs are categorized into following grades as per The Division of Aqcuired Immuno Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)- Grade 1- mild, Grade 2- moderate; Grade 3- severe and Grade 4- potentially life-threatening. Higher the grade, more severe the symptoms.

Number of Participants With AEs by Maximum Toxicity-Continuation Phase

Number of participants with Grade 1-4 AEs were assessed in Continuation Phase. AEs are categorized into following grades as per The Division of Aqcuired Immuno Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)- Grade 1- mild, Grade 2- moderate; Grade 3- severe and Grade 4- potentially life-threatening. Higher the grade, more severe the symptoms.

Number of Participants With Any Adverse Events (AEs), and Serious Adverse Events (SAEs)-Randomized Phase

An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or other events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the outcome listed above, liver injury and impaired liver function and grade 4 laboratory abnormalities. Number of participants with any AEs, and SAEs have been presented.

Number of Participants With Any AEs, and SAEs in Continuation Phase

Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase

Number of participants with Grade 1-4 emergent chemistry toxicities were assessed from the start of study treatment and end of Randomized Phase. Chemistry toxicities were categorized into following grades as per The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)- Grade 1- mild, Grade 2- moderate; Grade 3- severe and Grade 4- potentially life-threatening. Higher the grade, more severe the symptoms. Data has been reported for clinical chemistry parameters including hyperglycaemia, hyperkalemia, hypernatremia, hypoglycaemia, hypokalemia, hyponatremia, alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bilirubin, carbon dioxide, cholesterol, creatine kinase, creatinine, LDL cholesterol calculation, LDL cholesterol direct, lipase, phosphate, potassium, sodium, triglycerides and glucose.

Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase

Number of participants with grades 1-4 emergent chemistry toxicities were assessed in Continuation Phase. Chemistry toxicities were categorized into following grades as per The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)- Grade 1- mild, Grade 2- moderate; Grade 3- severe and Grade 4- potentially life-threatening. Higher the grade, more severe the symptoms. Data has been reported for clinical chemistry parameters including hyperglycaemia, hypernatremia, hypoglycaemia, hypokalemia, hyponatremia, alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bilirubin, carbon dioxide, cholesterol, creatine kinase, creatinine, LDL cholesterol calculation, LDL cholesterol direct, lipase, phosphate, potassium, sodium, triglycerides and glucose.

Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities-Randomized Phase

Number of participants with Grade 1-4 emergent hematology toxicities were assessed from the start of study treatment and end of Randomized Phase. Hematology toxicities were categorized into following grades as per The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)- Grade 1- mild, Grade 2- moderate; Grade 3- severe and Grade 4- potentially life-threatening. Higher the grade, more severe the symptoms. Data has been reported for clinical chemistry parameters including hemoglobin, leukocytes, neutrophils and platelets.

Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities-Continuation Phase

Number of participants with Grade 1-4 emergent hematology toxicities were assessed in Continuation Phase. Hematology toxicities were categorized into following grades as per The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)- Grade 1- mild, Grade 2- moderate; Grade 3- severe and Grade 4- potentially life-threatening. Higher the grade, more severe the symptoms. Data has been reported for clinical chemistry parameters including hemoglobin, leukocytes, neutrophils and platelets.

Number of Participants Who Withdrew From Treatment Due to AEs-Randomized Phase

An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of an MP. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is an important medical event that jeopardizes the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, or is associated with liver injury and impaired liver function.

Number of Participants Who Withdrew From Treatment Due to AEs-Continuation Phase

Change From Baseline in Bone Specific Alkaline Phosphatase, Osteocalcin and Procollagen 1 N-terminal Propeptide at Indicated Timepoints

Bone markers were assessed at Baseline (Day 1), Weeks 24, 48. Change from Baseline in bone specific alkaline phosphatase (BSAP), osteocalcin and procollagen 1 N-terminal propeptide (PTP) is summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.

Change From Baseline in Type I Collagen C-telopeptides at Indicated Timepoints

Bone markers were assessed at Baseline (Day 1), Weeks 24, 48. Change from Baseline in Type I collagen C-telopeptides (T-1 CCT) is summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.

Change From Baseline in Vitamin D, Vitamin D2 and Vitamin D3 at Week 24 and Week 48

Bone markers were assessed at Baseline (Day 1), Weeks 24, 48. Change from Baseline in vitamin D, vitamin D2 and vitamin D3 is summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.

Bone Specific Alkaline Phosphatase, Osteocalcin, Procollagen 1 N-terminal Propeptide, Type 1 Collagen C-Telopeptide, Vitamin D Ratio of Week 48 Results Over Baseline

Bone markers were assessed at indicated timepoints. Bone specific alkaline phosphatase (BSAP), osteocalcin and procollagen 1 N-terminal propeptide (PTP), Type 1 Collagen C-Telopeptide, vitamin D ratio of Week 48 results over Baseline is calculated. Bone biomarkers were analyzed based on log transformed data. Estimates of adjusted mean and difference were calculated from an Analysis of covariance (ANCOVA) model adjusting for age, baseline viral load Baseline CD4+ cell count, Baseline biomarker level, body mass index category, smoking status and baseline Vitamin D use. Adjusted mean of log-transformed change from Baseline are transformed back to Week 48/Baseline ratio for each treatment group. Adjusted difference of log-transformed change from Baseline between treatment groups is transformed back to the ratio of Week 48/Baseline ratio in DTG/ABC/3TC FDC to ATV+RTV+TDF/FTC FDC.

Change From Baseline at Week 48 in SF-12 Total Score, MCS and PCS

The 12-Item Short Form Health Survey (SF-12) is 12 item abbreviated form of SF-36 survey. SF-12 questions make up 8 scales: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional, Mental Health. SF-12 is a self-reported outcome measure assessing psychological wellness and the impact of health on an individual's everyday life. SF-12 total score ranges from 20 to 60 and higher score indicate a higher level of functioning. SF-12 total score was calculated by a clinician scoring 12-question survey filled by participants. Transformed physical component summary score (PCS) and transformed mental component summary score (MCS) are derived using the sum of all 12 items and scored onto a 0-100 scale such that a higher score indicates a better health state and better functioning. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.

HIVTSQs Total Score at Indicated Timepoints

The HIV treatment satisfaction questionnaire (HIVTSQ) is a 10-item self-reported scale that measures overall satisfaction with treatment and by specific domains e.g. convenience, flexibility. The HIVTSQ items are summed up to produce a treatment satisfaction total score (0 to 60) and an individual satisfaction rating for each item (0 to 6) and two subscales: general satisfaction/clinical and lifestyle/ease subscales. The higher the score, the greater the improvement in treatment satisfaction as compared to the past few weeks. A smaller score represents a decline in treatment satisfaction compared to the past few weeks. Statistical analysis was performed based on Wilcoxon rank sum test.

Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups

Percentage of participants with plasma HIV-1 RNA <50 copies/mL at Week 48 by subgroups (age, race, country, Baseline plasma HIV-1 RNA [BPHR], Baseline CD4+ cell count [BCCC], Baseline Centers for Disease Control and Prevention [CDC] category and HIV-1 subtype) were assessed using the Snapshot algorithm (Missing, Switch or Discontinuation = Failure). Analysis was performed using a stratified analysis with CMH weights, adjusting for Baseline plasma HIV-1 RNA ( =<versus [vs]. >100,000 c/mL) and CD4+ cell count (=<350 cells/mm^3 or >350 cells/mm^3). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT population. Percentage values are rounded off.

Number of Participants With Post-Baseline HIV-1 Disease Progression-Randomized Phase

Number of participants with post-Baseline HIV-1disease progression were assessed during study period. The CDC Classification System for HIV Infection is the medical classification system used by the United States Centers for Disease Control and Prevention (CDC) to classify HIV disease and infection. The clinical categories of HIV infection are defined as follows: Category A: Mildly symptomatic, Category B: Moderately symptomatic, Category C: Severely symptomatic. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Only those participants available at the specified time points were analyzed. Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT population.

Number of Participants With Post-Baseline HIV-1 Disease Progression for DTG 50 mg/ABC 600 mg/3TC 300 mg QD (Randomized + Continuation Phase)

Number of Participants With Treatment Emergent Resistances for DTG 50 mg/ABC 600 mg/3TC 300 mg QD (Randomized + Continuation Phase)

Number of participants, who meet confirmed virologic withdrawal criteria, with treatment emergent genotypic resistance to integrase strand transfer inhibitor (INSTI), Non-nucleoside reverse transcriptase inhibitor (NNRTI), nucleoside reverse transcriptase inhibitor (NRTI), protease inhibitors (PI) will be summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. On-treatment Genotypic Resistance Population comprised of all participants in the ITTE population with available On-treatment genotypic resistance data at the time confirmed virologic withdrawal criterion was met.

Number of Participants With Treatment Emergent Resistances for ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200mg QD (Randomized Phase)

Full Information

NCT ID

NCT01910402

First Posted

July 25, 2013

Last Updated

July 17, 2023

Sponsor

ViiV Healthcare

Collaborators

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT01910402

Brief Title

A Study to Determine Safety and Efficacy of Dolutegravir/Abacavir/Lamivudine (DTG/ABC/3TC) in Human Immunodeficiency Virus (HIV)-1 Infected Antiretroviral Therapy (ART) Naïve Women (ARIA)

Official Title

A Phase IIIb, Randomized, Open-label Study of the Safety and Efficacy of Dolutegravir/Abacavir/Lamivudine Once Daily Compared to Atazanavir and Ritonavir Plus Tenofovir/Emtricitabine Once Daily in HIV-1 Infected Antiretroviral Therapy Naïve Women

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Completed

Study Start Date

August 22, 2013 (Actual)

Primary Completion Date

September 22, 2015 (Actual)

Study Completion Date

August 18, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ViiV Healthcare

Collaborators

GlaxoSmithKline

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This study is designed to demonstrate the non-inferior antiviral activity of DTG/ABC/3TC fixed dose combination (FDC) once daily (OD) compared to atazanavir plus ritonavir (ATV+RTV) and tenofovir disoproxil fumarate/emtricitabine fixed dose combination (TDF/FTC FDC) OD in HIV-1 infected, ART-naïve women over 48 weeks. This study will also characterize the safety and tolerability of DTG/ABC/3TC FDC compared to ATV+RTV+TDF/FTC FDC. Sufficient number of subjects will be screened in order to ensure a total of approximately 474 subjects will be randomized (237 in each study arm)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infection, Human Immunodeficiency Virus, HIV Infections

Keywords

antiretroviral therapy naïve, women, once daily, HIV infection, atazanavir, tenofovir/emtricitabine, dolutegravir/abacavir/lamivudine fixed dose combination, integrase inhibitor, ritonavir

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

499 (Actual)

8. Arms, Groups, and Interventions

Arm Title

DTG/ABC/3TC FDC

Arm Type

Experimental

Arm Description

Arm Title

ATV +RTV +TDF/FTC FDC

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Dolutegravir/abacavir/lamivudine FDC

Intervention Description

Dolutegravir/abacavir/lamivudine FDC tablets, 50 mg/600 mg/300 mg

Intervention Type

Drug

Intervention Name(s)

Atazanavir

Intervention Description

Atazanavir capsule 300 mg

Intervention Type

Drug

Intervention Name(s)

Ritonavir

Intervention Description

Ritonavir tablet 100 mg

Intervention Type

Drug

Intervention Name(s)

Tenofovir/emtricitabine FDC

Intervention Description

Tenofovir/emtricitabine FDC tablet 300 mg/200 mg of FTC

Primary Outcome Measure Information:

Title

Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48

Description

Time Frame

Week 48

Secondary Outcome Measure Information:

Title

Percentage of Participants With Plasma HIV-1 RNA <50 and <400 c/mL Over Time-Randomized Phase

Description

Time Frame

Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48

Title

Percentage of Participants With Plasma HIV-1 RNA <50 c/mL in Continuation Phase

Description

Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with plasma HIV-1 RNA <50 c/mL were reported. Percentage values are rounded off.

Time Frame

Week 96 and Week 432

Title

Change From Baseline in Plasma HIV-1 RNA at Indicated Time Points-Randomized Phase

Description

Time Frame

Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48

Title

Change From Baseline in Plasma HIV-1 RNA at Indicated Time Points-Continuation Phase

Description

Time Frame

Baseline (Day 1), Week 96 and Week 432

Title

Absolute Values in Plasma HIV-1 RNA at Indicated Time Points-Randomized Phase

Description

Absolute Values in plasma HIV-1 RNA were assessed at indicated time points. The Baseline value was defined as the latest pre-dose assessment (Day 1) value.

Time Frame

Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48

Title

Absolute Values in Plasma HIV-1 RNA at Indicated Time Points-Continuation Phase

Description

Absolute Values in plasma HIV-1 RNA were assessed at indicated time points.

Time Frame

Week 96 and Week 432

Title

Change From Baseline in CD4+ Cell Count at Indicated Timepoints-Randomized Phase

Description

Time Frame

Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48

Title

Change From Baseline in CD4+ Cell Count at Indicated Timepoints-Continuation Phase

Description

Change from Baseline in cluster of differentiation 4(CD4+) cell count were assessed at indicated time points. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.

Time Frame

Baseline (Day 1), Week 96, Week 432

Title

Absolute Values in CD4+ Cell Count at Indicated Timepoints-Randomized Phase

Description

Absolute values in CD4+ cell count were assessed at indicated time points. The Baseline value was defined as the latest pre-dose assessment (Day 1) value.

Time Frame

Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48

Title

Absolute Values in CD4+ Cell Count at Indicated Timepoints-Continuation Phase

Description

Absolute values in CD4+ cell count were assessed at indicated time points.

Time Frame

Week 96 and Week 432

Title

Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points

Description

Time Frame

Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48

Title

Change From Baseline in Bilirubin and Creatinine at Indicated Timepoints

Description

Time Frame

Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48

Title

Change From Baseline in Albumin at Indicated Timepoints

Description

Time Frame

Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48

Title

Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase at Indicated Time Points

Description

Time Frame

Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48

Title

Change From Baseline in Creatinine Clearance at Indicated Time Points

Description

Time Frame

Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48

Title

Change From Baseline in Lipase at Indicated Timepoints

Description

Time Frame

Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48

Title

Change From Baseline in Total CHLS/HDL CHLS Ratio at Indicated Timepoints

Description

Time Frame

Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48

Title

Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes at Indicated Time Points

Description

Time Frame

Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48

Title

Change From Baseline in Erythrocytes at Indicated Time Points

Description

Time Frame

Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48

Title

Change From Baseline in Hematocrit Count at Indicated Time Points

Description

Time Frame

Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48

Title

Change From Baseline in Erythrocyte Mean Corpuscular Volume at Indicated Time Points

Description

Time Frame

Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48

Title

Change From Baseline in Triglycerides at Week 48

Description

Time Frame

Baseline (Day 1) and Week 48

Title

Change From Baseline in TC/HDL Ratio at Week 48

Description

Time Frame

Baseline (Day 1) and Week 48

Title

Change From Baseline in Urine Albumin Creatinine Ratio at Indicated Time Points

Description

Time Frame

Baseline (Day 1), Week 24 and Week 48

Title

Number of Participants With AEs by Maximum Toxicity-Randomized Phase

Description

Time Frame

Up to Week 48

Title

Number of Participants With AEs by Maximum Toxicity-Continuation Phase

Description

Time Frame

From Weeks 48 to 432

Title

Number of Participants With Any Adverse Events (AEs), and Serious Adverse Events (SAEs)-Randomized Phase

Description

Time Frame

Up to Week 48

Title

Number of Participants With Any AEs, and SAEs in Continuation Phase

Description

Time Frame

From Weeks 48 to 432

Title

Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase

Description

Time Frame

Up to Week 48

Title

Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase

Description

Time Frame

From Weeks 48 to 432

Title

Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities-Randomized Phase

Description

Time Frame

Up to Week 48

Title

Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities-Continuation Phase

Description

Time Frame

From Weeks 48 to 432

Title

Number of Participants Who Withdrew From Treatment Due to AEs-Randomized Phase

Description

Time Frame

Up to Week 48

Title

Number of Participants Who Withdrew From Treatment Due to AEs-Continuation Phase

Description

Time Frame

From Weeks 48 to 432

Title

Change From Baseline in Bone Specific Alkaline Phosphatase, Osteocalcin and Procollagen 1 N-terminal Propeptide at Indicated Timepoints

Description

Time Frame

Baseline (Day 1), Weeks 24 and 48

Title

Change From Baseline in Type I Collagen C-telopeptides at Indicated Timepoints

Description

Time Frame

Baseline (Day 1), Weeks 24 and 48

Title

Change From Baseline in Vitamin D, Vitamin D2 and Vitamin D3 at Week 24 and Week 48

Description

Time Frame

Baseline (Day 1), Weeks 24 and 48

Title

Bone Specific Alkaline Phosphatase, Osteocalcin, Procollagen 1 N-terminal Propeptide, Type 1 Collagen C-Telopeptide, Vitamin D Ratio of Week 48 Results Over Baseline

Description

Time Frame

Baseline (Day 1) and Week 48

Title

Change From Baseline at Week 48 in SF-12 Total Score, MCS and PCS

Description

Time Frame

Baseline (Day 1) and Week 48

Title

HIVTSQs Total Score at Indicated Timepoints

Description

Time Frame

Weeks 4, 12, 24 and 48

Title

Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups

Description

Time Frame

Week 48

Title

Number of Participants With Post-Baseline HIV-1 Disease Progression-Randomized Phase

Description

Time Frame

Up to week 48

Title

Number of Participants With Post-Baseline HIV-1 Disease Progression for DTG 50 mg/ABC 600 mg/3TC 300 mg QD (Randomized + Continuation Phase)

Description

Time Frame

Up to week 432

Title

Number of Participants With Treatment Emergent Resistances for DTG 50 mg/ABC 600 mg/3TC 300 mg QD (Randomized + Continuation Phase)

Description

Time Frame

Up to week 432

Title

Number of Participants With Treatment Emergent Resistances for ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200mg QD (Randomized Phase)

Description

Time Frame

Up to week 48

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: HIV-1 infected females (gender at birth) >=18 years of age Women capable of becoming pregnant must use appropriate contraception during the study (as defined by the protocol) HIV-1 infection as documented by Screening plasma HIV-1 RNA >=500 c/mL. Documentation that the subject is negative for the HLA-B*5701 allele. Antiretroviral-naïve (<=10 days of prior therapy with any antiretroviral agent following a diagnosis of HIV-1 infection). Signed and dated written informed consent is obtained from the subject or the subject's legal representative prior to screening. Exclusion Criteria: Women who are pregnant or breastfeeding Women who plan to become pregnant during the first 48 weeks of the study Any subject who has had a medical intervention for gender reassignment Any evidence of an active Centers for Disease Control and Prevention (CDC) Category C disease Subjects with any degree of hepatic impairment Subjects positive for hepatitis B at Screening, or anticipated need for HCV therapy during the study History or presence of allergy to the study drugs or their components or drugs of their class Ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma, or cervical intraepithelial neoplasia poses a significant suicidality risk History of osteoporosis with fracture or requiring pharmacologic therapy Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening Treatment with any of the following agents within 28 days of Screening: radiation therapy; cytotoxic chemotherapeutic agents; any immunomodulators that alter immune responses; Treatment with any agent, with documented activity against HIV-1 in vitro within 28 days of first dose of investigational product (IP) Exposure to an experimental drug or experimental vaccine within either 28 days, 5 half-lives of the test agent, or twice the duration of the biological effect of the test agent, whichever is longer, prior to the first dose of IP Any evidence of primary viral resistance based on the presence of any major resistance-associated mutation in the Screening result or, if known, any historical resistance test result Any verified Grade 4 laboratory abnormality, with the exception of Grade 4 lipid abnormalities (total cholesterol, triglycerides, High Density Lipoprotein (HDL) cholesterol, Low Density Lipoprotein (LDL) cholesterol) Any acute laboratory abnormality at Screening, which, in the opinion of the Investigator, would preclude the subject's participation in the study of an investigational compound Alanine aminotransferase (ALT) ≥5 times the upper limit of normal (ULN), or ALT ≥ 3xULN and bilirubin ≥ 1.5xULN (with >35% direct bilirubin) Subject has CrCL of <50 mL/min via Cockroft-Gault method Corrected QT interval (QTc (Bazett)) ≥450msec or QTc (Bazett) ≥480msec for subjects with bundle branch block.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GSK Clinical Trials

Organizational Affiliation

ViiV Healthcare

Official's Role

Study Director

Facility Information:

Facility Name

GSK Investigational Site

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85015

Country

United States

Facility Name

GSK Investigational Site

City

Bakersfield

State/Province

California

ZIP/Postal Code

93301

Country

United States

Facility Name

GSK Investigational Site

City

Beverly Hills

State/Province

California

ZIP/Postal Code

90211

Country

United States

Facility Name

GSK Investigational Site

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20007

Country

United States

Facility Name

GSK Investigational Site

City

Fort Pierce

State/Province

Florida

ZIP/Postal Code

34982

Country

United States

Facility Name

GSK Investigational Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33133

Country

United States

Facility Name

GSK Investigational Site

City

Orlando

State/Province

Florida

ZIP/Postal Code

32803

Country

United States

Facility Name

GSK Investigational Site

City

Tampa

State/Province

Florida

ZIP/Postal Code

33602

Country

United States

Facility Name

GSK Investigational Site

City

West Palm Beach

State/Province

Florida

ZIP/Postal Code

33401

Country

United States

Facility Name

GSK Investigational Site

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30309

Country

United States

Facility Name

GSK Investigational Site

City

Augusta

State/Province

Georgia

ZIP/Postal Code

30912-3130

Country

United States

Facility Name

GSK Investigational Site

City

Decatur

State/Province

Georgia

ZIP/Postal Code

30033

Country

United States

Facility Name

GSK Investigational Site

City

Savannah

State/Province

Georgia

ZIP/Postal Code

31401

Country

United States

Facility Name

GSK Investigational Site

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

Facility Name

GSK Investigational Site

City

Springfield

State/Province

Massachusetts

ZIP/Postal Code

01199

Country

United States

Facility Name

GSK Investigational Site

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48202

Country

United States

Facility Name

GSK Investigational Site

City

Kansas City

State/Province

Missouri

ZIP/Postal Code

64111

Country

United States

Facility Name

GSK Investigational Site

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Facility Name

GSK Investigational Site

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68198

Country

United States

Facility Name

GSK Investigational Site

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89106

Country

United States

Facility Name

GSK Investigational Site

City

Neptune

State/Province

New Jersey

ZIP/Postal Code

7754

Country

United States

Facility Name

GSK Investigational Site

City

Newark

State/Province

New Jersey

ZIP/Postal Code

07103

Country

United States

Facility Name

GSK Investigational Site

City

Buffalo

State/Province

New York

ZIP/Postal Code

14215

Country

United States

Facility Name

GSK Investigational Site

City

Valhalla

State/Province

New York

ZIP/Postal Code

10595

Country

United States

Facility Name

GSK Investigational Site

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27514

Country

United States

Facility Name

GSK Investigational Site

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28207

Country

United States

Facility Name

GSK Investigational Site

City

Greensboro

State/Province

North Carolina

ZIP/Postal Code

27401-1209

Country

United States

Facility Name

GSK Investigational Site

City

Allentown

State/Province

Pennsylvania

ZIP/Postal Code

18102

Country

United States

Facility Name

GSK Investigational Site

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Facility Name

GSK Investigational Site

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19107

Country

United States

Facility Name

GSK Investigational Site

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19140

Country

United States

Facility Name

GSK Investigational Site

City

Bellaire

State/Province

Texas

ZIP/Postal Code

77401

Country

United States

Facility Name

GSK Investigational Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75235

Country

United States

Facility Name

GSK Investigational Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75246

Country

United States

Facility Name

GSK Investigational Site

City

El Paso

State/Province

Texas

ZIP/Postal Code

79905

Country

United States

Facility Name

GSK Investigational Site

City

Fort Worth

State/Province

Texas

ZIP/Postal Code

76104

Country

United States

Facility Name

GSK Investigational Site

City

Lynchburg

State/Province

Virginia

ZIP/Postal Code

24501

Country

United States

Facility Name

GSK Investigational Site

City

Ciudad Autónoma de Buenos Aires

State/Province

Buenos Aires

ZIP/Postal Code

C1405CKC

Country

Argentina

Facility Name

GSK Investigational Site

City

Ciudad de Buenos Aires

State/Province

Buenos Aires

ZIP/Postal Code

C1202ABB

Country

Argentina

Facility Name

GSK Investigational Site

City

Buenos Aires

ZIP/Postal Code

1141

Country

Argentina

Facility Name

GSK Investigational Site

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V6Z 1Y6

Country

Canada

Facility Name

GSK Investigational Site

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K1H 8L6

Country

Canada

Facility Name

GSK Investigational Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M4N 3M5

Country

Canada

Facility Name

GSK Investigational Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 2N2

Country

Canada

Facility Name

GSK Investigational Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H2X 2P4

Country

Canada

Facility Name

GSK Investigational Site

City

Bobigny

ZIP/Postal Code

93009

Country

France

Facility Name

GSK Investigational Site

City

Nantes

ZIP/Postal Code

44093

Country

France

Facility Name

GSK Investigational Site

City

Paris Cedex 10

ZIP/Postal Code

75475

Country

France

Facility Name

GSK Investigational Site

City

Genova

State/Province

Liguria

ZIP/Postal Code

16128

Country

Italy

Facility Name

GSK Investigational Site

City

Bergamo

State/Province

Lombardia

ZIP/Postal Code

24127

Country

Italy

Facility Name

GSK Investigational Site

City

Brescia

State/Province

Lombardia

ZIP/Postal Code

25123

Country

Italy

Facility Name

GSK Investigational Site

City

Busto Arsizio (VA)

State/Province

Lombardia

ZIP/Postal Code

21052

Country

Italy

Facility Name

GSK Investigational Site

City

Milano

State/Province

Lombardia

ZIP/Postal Code

20127

Country

Italy

Facility Name

GSK Investigational Site

City

Milano

State/Province

Lombardia

ZIP/Postal Code

20157

Country

Italy

Facility Name

GSK Investigational Site

City

Torino

State/Province

Piemonte

ZIP/Postal Code

10149

Country

Italy

Facility Name

GSK Investigational Site

City

Guadalajara

State/Province

Jalisco

ZIP/Postal Code

44280

Country

Mexico

Facility Name

GSK Investigational Site

City

Mexico

ZIP/Postal Code

14000

Country

Mexico

Facility Name

GSK Investigational Site

City

Amadora

ZIP/Postal Code

2720-276

Country

Portugal

Facility Name

GSK Investigational Site

City

Lisboa

ZIP/Postal Code

1150

Country

Portugal

Facility Name

GSK Investigational Site

City

Porto

ZIP/Postal Code

4200-319

Country

Portugal

Facility Name

GSK Investigational Site

City

Ponce

ZIP/Postal Code

00717

Country

Puerto Rico

Facility Name

GSK Investigational Site

City

Rio Piedras

ZIP/Postal Code

00936

Country

Puerto Rico

Facility Name

GSK Investigational Site

City

San Juan

ZIP/Postal Code

00909

Country

Puerto Rico

Facility Name

GSK Investigational Site

City

Moscow

ZIP/Postal Code

115035

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Orel

ZIP/Postal Code

302040

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Smolensk

ZIP/Postal Code

214006

Country

Russian Federation

Facility Name

GSK Investigational Site

City

St. Petersburg

ZIP/Postal Code

190103

Country

Russian Federation

Facility Name

GSK Investigational Site

City

St. Petersburg

ZIP/Postal Code

196645

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Toliyatti

ZIP/Postal Code

445846

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Observatory, Cape Town

State/Province

Western Province

ZIP/Postal Code

7925

Country

South Africa

Facility Name

GSK Investigational Site

City

Mamelodi East

ZIP/Postal Code

122

Country

South Africa

Facility Name

GSK Investigational Site

City

(Móstoles) Madrid

ZIP/Postal Code

28935

Country

Spain

Facility Name

GSK Investigational Site

City

Alicante

ZIP/Postal Code

03010

Country

Spain

Facility Name

GSK Investigational Site

City

Badalona

ZIP/Postal Code

08916

Country

Spain

Facility Name

GSK Investigational Site

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Facility Name

GSK Investigational Site

City

Barcelona

ZIP/Postal Code

08907

Country

Spain

Facility Name

GSK Investigational Site

City

Granada

ZIP/Postal Code

18012

Country

Spain

Facility Name

GSK Investigational Site

City

Madrid

ZIP/Postal Code

28034

Country

Spain

Facility Name

GSK Investigational Site

City

Madrid

ZIP/Postal Code

28046

Country

Spain

Facility Name

GSK Investigational Site

City

Malaga

ZIP/Postal Code

29010

Country

Spain

Facility Name

GSK Investigational Site

City

Murcia

ZIP/Postal Code

30003

Country

Spain

Facility Name

GSK Investigational Site

City

Sevilla

ZIP/Postal Code

41013

Country

Spain

Facility Name

GSK Investigational Site

City

Bangkok

ZIP/Postal Code

10330

Country

Thailand

Facility Name

GSK Investigational Site

City

Nonthaburi

ZIP/Postal Code

11000

Country

Thailand

Facility Name

GSK Investigational Site

City

Birmingham

ZIP/Postal Code

B9 5SS

Country

United Kingdom

Facility Name

GSK Investigational Site

City

London

ZIP/Postal Code

E1 1BB

Country

United Kingdom

Facility Name

GSK Investigational Site

City

London

ZIP/Postal Code

NW3 2QG

Country

United Kingdom

Facility Name

GSK Investigational Site

City

London

ZIP/Postal Code

W2 1NY

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Sheffield

ZIP/Postal Code

S10 2JF

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Tooting, London

ZIP/Postal Code

SW17 0QT

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

28729158

Citation

Orrell C, Hagins DP, Belonosova E, Porteiro N, Walmsley S, Falco V, Man CY, Aylott A, Buchanan AM, Wynne B, Vavro C, Aboud M, Smith KY; ARIA study team. Fixed-dose combination dolutegravir, abacavir, and lamivudine versus ritonavir-boosted atazanavir plus tenofovir disoproxil fumarate and emtricitabine in previously untreated women with HIV-1 infection (ARIA): week 48 results from a randomised, open-label, non-inferiority, phase 3b study. Lancet HIV. 2017 Dec;4(12):e536-e546. doi: 10.1016/S2352-3018(17)30095-4. Epub 2017 Jul 17. Erratum In: Lancet HIV. 2017 Dec;4(12 ):e535.

Results Reference

derived

Learn more about this trial

A Study to Determine Safety and Efficacy of Dolutegravir/Abacavir/Lamivudine (DTG/ABC/3TC) in Human Immunodeficiency Virus (HIV)-1 Infected Antiretroviral Therapy (ART) Naïve Women (ARIA)

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A Study to Determine Safety and Efficacy of Dolutegravir/Abacavir/Lamivudine (DTG/ABC/3TC) in Human Immunodeficiency Virus (HIV)-1 Infected Antiretroviral Therapy (ART) Naïve Women (ARIA)

Infection, Human Immunodeficiency Virus, HIV Infections

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial