Same-Day Treatment With Genvoya vs. EFV/TDF/3TC
Primary Purpose
HIV/AIDS
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Elvitegravir, Cobicistat, TAF, FTC
Efavirenz, TDF, and 3TC
Sponsored by
About this trial
This is an interventional treatment trial for HIV/AIDS focused on measuring HIV/AIDS, Same-Day ART, Genvoya, Efavirenz
Eligibility Criteria
Inclusion Criteria:
- Documentation of positive HIV status (test conducted at GHESKIO);
- At least 18 years of age;
- Unaware of HIV diagnosis prior to date of enrollment, and ART-naïve;
- Ability and willingness to give written informed consent;
- Ready to initiate same-day ART, according to two criteria: (1) HIV medication readiness questionnaire; and (2) social worker assessment;
- WHO Stage 1 or 2 disease, as defined by the following conditions: asymptomatic; persistent generalized lymphadenopathy; unexplained weight loss (under 10%); recurrent upper respiratory tract infections; herpes zoster; angular chelitis; recurrent oral ulcerations; papular pruritic eruptions; seborrheic dermatitis; or fungal nail infections.
- Female participants may be enrolled if they are either: (1) post-menopausal; (2) physically incapable of becoming pregnant due to tubal ligation, hysterectomy, or bilateral oophorectomy; or (3) are of childbearing potential, and agree to use one of the following methods to avoid pregnancy throughout the duration of the study:
Complete abstinence from intercourse; Double barrier method, such as male condom/spermicide, male condom/diaphragm, or diaphragm/spermicide; Hormonal contraception plus a barrier method; Intrauterine device (IUD); Male partner sterilization (if participant has only one sexual partner);
Exclusion Criteria:
- Pregnancy or breastfeeding at the screening visit;
- Active drug, alcohol use, or mental condition that would interfere with the ability to adhere to study requirements, in the opinion of the study physician;
- World Health Organization Stage 3 or 4 disease, as defined by the following conditions: unexplained severe weight loss (over 10% of presumed or measured body weight); unexplained chronic diarrhea for longer than 1 month; unexplained persistent fever (intermittent or constant for longer than 1 month); persistent oral candidiasis; oral hairy leukoplakia; pulmonary tuberculosis; severe bacterial infections (e.g. pneumonia, empyema, meningitis, pyomyositis, bone or joint infection, bacteremia, severe pelvic inflammatory disease); or acute necrotizing ulcerative stomatitis, gingivitis or periodontitis.
- Clinical evidence of cirrhosis (ascites or encephalopathy);
- Anticipated need for hepatitis C therapy during the study period;
- Baseline CrCl <30 mL/minute by the Cockcroft-Gault equation (late exclusion, as creatinine results will not be available at the time of enrollment);
- Either the K65R mutation or more than 3 thymidine analogue mutations on baseline resistance testing (late exclusions, after baseline resistance results are available).
- Planning to transfer care to another clinic during the study period;
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Elvitegravir-Cobicistat-TAF-FTC
EFV-TDF-3TC
Arm Description
Elvitegravir 150mg po QD Cobicistat 150 mg po QD TAF 10 mg po QD FTC 200 mg QD
EFV 600 mg po QD TDF 300 mg po QD 3TC 300 mg po QD
Outcomes
Primary Outcome Measures
48-week viral suppression
To compare the proportion of participants who are retained in care with a plasma HIV-1 RNA level <200 copies/ml
Secondary Outcome Measures
12-week viral suppression
Proportion of participants who are retained in care with a plasma HIV-1 RNA level <200 copies/ml
Baseline resistance to ART medications
Genotypic resistance to EFV and/or nucleoside reverse transcriptase inhibitors
Change in CD4 count
Median change in CD4 count over the study period (baseline to 48 weeks)
Virologic failure
Proportion of patients meeting the WHO definition for ART treatment failure over the study period
Adverse events
Proportion of participants with a new Division of AIDS Grade 3 or 4 adverse event or laboratory abnormality that is at least a one-grade increase from baseline
Neurologic or psychiatric adverse event
Proportion of participants with a new Division of AIDS Grade 1 to 4 neurologic or psychiatric disorder that is at least a one-grade increase from baseline
Sleep Quality
Mean scores on the Pittsburgh Sleep Quality Index
Depression
Mean scores on the Patient Health Questionnaires (PHQ-9) Questionnaire
Change in ART drugs
Proportion of participants who discontinue any drug in the original ART regimen
Full Information
NCT ID
NCT03405194
First Posted
December 24, 2017
Last Updated
March 16, 2020
Sponsor
Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic
Collaborators
Gilead Sciences, Brigham and Women's Hospital, Weill Medical College of Cornell University, Analysis Group, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03405194
Brief Title
Same-Day Treatment With Genvoya vs. EFV/TDF/3TC
Official Title
An Open-Label, Randomized Comparison of Elvitegravir-Cobicistat-Tenofovir Alafenamide-Emtricitabine Versus Efavirenz-Tenofovir Disoproxil Fumarate-Lamivudine in Patients Starting Antiretroviral Therapy on the Day of HIV Diagnosis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Haiti gained access to dolutegravir as first-line ART, so we cancelled the study before any patient was enrolled (we didn't want SOC group to receive EFV)
Study Start Date
May 1, 2018 (Anticipated)
Primary Completion Date
May 1, 2020 (Anticipated)
Study Completion Date
July 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic
Collaborators
Gilead Sciences, Brigham and Women's Hospital, Weill Medical College of Cornell University, Analysis Group, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Randomized, open-label study comparing Elvitegravir-Cobicistat-Tenofovir Alafenamide-Emtricitabine (Genvoya) vs. Efavirenz-Tenofovir Disoproxil Fumarate-Lamivudine (EFV-TDF-3TC) in patients starting ART on the day of HIV diagnosis.
Detailed Description
Patients with WHO Stage 1 or 2 disease at HIV diagnosis will be randomized in a 1:1 ratio to either the Genvoya group or the EFV-TDF-3TC group. ART will be initiated on the day of HIV diagnosis. Participants who are found to have a contraindication to their assigned treatment regimen will change ART, and be classified as a failure for their assigned treatment arm. Participants in the EFV-TDF-3TC group with CrCl of 30-50 mL/minute, or with baseline mutations that significantly reduce the susceptibility of EFV will switch to Genvoya. Participants in the Genvoya group who are diagnosed with TB after enrollment will be switched to an ART regimen that can be administered with rifampin. If the study physician determines that a treatment change is indicated due to intolerability or side effects, the relevant clinical data will be presented to a safety committee that is blinded to group assignment. The ART regimen will be changed if the safety committee determines that it is indicated, and the participant will be considered a failure to their assigned treatment group. Patients will be followed for 48 weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV/AIDS
Keywords
HIV/AIDS, Same-Day ART, Genvoya, Efavirenz
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Same-Day ART with Genvoya vs. EFV/TDF/3TC
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Elvitegravir-Cobicistat-TAF-FTC
Arm Type
Experimental
Arm Description
Elvitegravir 150mg po QD Cobicistat 150 mg po QD TAF 10 mg po QD FTC 200 mg QD
Arm Title
EFV-TDF-3TC
Arm Type
Active Comparator
Arm Description
EFV 600 mg po QD TDF 300 mg po QD 3TC 300 mg po QD
Intervention Type
Drug
Intervention Name(s)
Elvitegravir, Cobicistat, TAF, FTC
Intervention Description
Started on day of HIV diagnosis
Intervention Type
Drug
Intervention Name(s)
Efavirenz, TDF, and 3TC
Intervention Description
Started on day of HIV diagnosis
Primary Outcome Measure Information:
Title
48-week viral suppression
Description
To compare the proportion of participants who are retained in care with a plasma HIV-1 RNA level <200 copies/ml
Time Frame
48 weeks after enrollment
Secondary Outcome Measure Information:
Title
12-week viral suppression
Description
Proportion of participants who are retained in care with a plasma HIV-1 RNA level <200 copies/ml
Time Frame
12 weeks after enrollment
Title
Baseline resistance to ART medications
Description
Genotypic resistance to EFV and/or nucleoside reverse transcriptase inhibitors
Time Frame
Baseline
Title
Change in CD4 count
Description
Median change in CD4 count over the study period (baseline to 48 weeks)
Time Frame
48 weeks after enrollment
Title
Virologic failure
Description
Proportion of patients meeting the WHO definition for ART treatment failure over the study period
Time Frame
48 weeks after enrollment
Title
Adverse events
Description
Proportion of participants with a new Division of AIDS Grade 3 or 4 adverse event or laboratory abnormality that is at least a one-grade increase from baseline
Time Frame
48 weeks after HIV testing
Title
Neurologic or psychiatric adverse event
Description
Proportion of participants with a new Division of AIDS Grade 1 to 4 neurologic or psychiatric disorder that is at least a one-grade increase from baseline
Time Frame
48 weeks
Title
Sleep Quality
Description
Mean scores on the Pittsburgh Sleep Quality Index
Time Frame
4, 12, 24, and 48 weeks after enrollment
Title
Depression
Description
Mean scores on the Patient Health Questionnaires (PHQ-9) Questionnaire
Time Frame
4, 12, 24, and 48 weeks after enrollment
Title
Change in ART drugs
Description
Proportion of participants who discontinue any drug in the original ART regimen
Time Frame
48 weeks after HIV testing after enrollment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Documentation of positive HIV status (test conducted at GHESKIO);
At least 18 years of age;
Unaware of HIV diagnosis prior to date of enrollment, and ART-naïve;
Ability and willingness to give written informed consent;
Ready to initiate same-day ART, according to two criteria: (1) HIV medication readiness questionnaire; and (2) social worker assessment;
WHO Stage 1 or 2 disease, as defined by the following conditions: asymptomatic; persistent generalized lymphadenopathy; unexplained weight loss (under 10%); recurrent upper respiratory tract infections; herpes zoster; angular chelitis; recurrent oral ulcerations; papular pruritic eruptions; seborrheic dermatitis; or fungal nail infections.
Female participants may be enrolled if they are either: (1) post-menopausal; (2) physically incapable of becoming pregnant due to tubal ligation, hysterectomy, or bilateral oophorectomy; or (3) are of childbearing potential, and agree to use one of the following methods to avoid pregnancy throughout the duration of the study:
Complete abstinence from intercourse; Double barrier method, such as male condom/spermicide, male condom/diaphragm, or diaphragm/spermicide; Hormonal contraception plus a barrier method; Intrauterine device (IUD); Male partner sterilization (if participant has only one sexual partner);
Exclusion Criteria:
Pregnancy or breastfeeding at the screening visit;
Active drug, alcohol use, or mental condition that would interfere with the ability to adhere to study requirements, in the opinion of the study physician;
World Health Organization Stage 3 or 4 disease, as defined by the following conditions: unexplained severe weight loss (over 10% of presumed or measured body weight); unexplained chronic diarrhea for longer than 1 month; unexplained persistent fever (intermittent or constant for longer than 1 month); persistent oral candidiasis; oral hairy leukoplakia; pulmonary tuberculosis; severe bacterial infections (e.g. pneumonia, empyema, meningitis, pyomyositis, bone or joint infection, bacteremia, severe pelvic inflammatory disease); or acute necrotizing ulcerative stomatitis, gingivitis or periodontitis.
Clinical evidence of cirrhosis (ascites or encephalopathy);
Anticipated need for hepatitis C therapy during the study period;
Baseline CrCl <30 mL/minute by the Cockcroft-Gault equation (late exclusion, as creatinine results will not be available at the time of enrollment);
Either the K65R mutation or more than 3 thymidine analogue mutations on baseline resistance testing (late exclusions, after baseline resistance results are available).
Planning to transfer care to another clinic during the study period;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean W Pape, MD
Organizational Affiliation
Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Serena P Koenig, MD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Same-Day Treatment With Genvoya vs. EFV/TDF/3TC
We'll reach out to this number within 24 hrs