Back to results

Nevirapine or Atazanavir/Ritonavir Given With Emtricitabine/Tenofovir in Human Immunodeficiency Virus (HIV)-1-infected Treatment Naive Adults

Primary Purpose

HIV Infections

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

nevirapine bid

nevirapine qd

atazanavir

About this trial

This is an interventional treatment trial for HIV Infections

Eligibility Criteria

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

Inclusion criteria:

Inclusion Criteria:

Signed informed consent in accordance with Good Clinical Practice (GCP) and local regulatory requirements prior to trial participation
HIV-1-infected males or females >= 18 years of age with positive serology confirmed by Western blot
No previous antiretroviral treatment (of more than 7 days)
Males with CD4+ counts of < 400 cells/mm3 and females with CD4+ counts of < 250 cells/mm3
NVP- and ATZ/r susceptibility based on HIV-1 genotypic resistance report
Adequate renal function defined as a calculated creatinine clearance (CLCr) >= 50 ml/min according to the Cockcroft-Gault formula
Karnofsky score >= 70
Acceptable medical history, as assessed by the investigator

Exclusion criteria:

Exclusion Criteria:

Active drug abuse or chronic alcoholism at the investigator's discretion
Hepatic cirrhosis stage Child-Pugh B or C
Female patients of child-bearing potential who:
- have a positive serum pregnancy test at screening or during the study,
- are breast feeding,
- are planning to become pregnant,
- are not willing to use a barrier method of contraception, or are not willing to use methods of contraception other than ethinyl estradiol containing oral contraceptives
Laboratory parameters Division of Acquired Immunodeficiency Syndrome (DAIDS) > grade 2 (triglycerides > DAIDS grade 3; total cholesterol no restrictions)
Active hepatitis B or C disease, defined as HBsAg-positive or Hepatitis C-Virus-Ribo Nucleic Acid (HCV-RNA)- positive with Aspartate Transaminase/Alanine Transaminase (AST/ALT) > 2.5x Upper Limit of Normal (ULN) (DAIDS grade 1)
Hypersensitivity to any ingredients of the test products
Have therapy with nephrotoxic drugs (e.g., aminoglycosides, amphotericin B, vancomycin, cidofovir, foscarnet, cisplatin, pentamidine, tacrolimus, cyclosporine) or potential competitors of renal excretion (e.g., cidofovir, acyclovir, valacyclovir, ganciclovir, valganciclovir, probenecid, high-dose non-steroidal anti-inflammatory drugs (i.e., ibuprofen)) within 3 months prior to study screening or are expected to receive these during the study
Patients who are receiving other concomitant treatments which are not permitted
Use of other investigational medications within 30 days before study entry or during the trial
Use of immunomodulatory drugs within 30 days before study entry or during the trial (e.g., interferon, cyclosporin, hydroxyurea, interleukin 2, chronic treatment with prednisone)
Patients with Progressive Multifocal Leukoencephalopathy (PML), Visceral Kaposi's Sarcoma (KS), and/or any lymphoma
Any AIDS defining illness that is unresolved, symptomatic or not stable on treatment for at least 12 weeks at screening visit
Patients who are receiving systemic treatment for malignant disease

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Active Comparator

Arm Label

NVP bid

NVP qd

ATZ/r

Arm Description

nevirapine (NVP) 200 mg BID in combination with emtricitabine (FTC) and tenofovir DF (TDF)

nevirapine (NVP) 400 mg QD in combination with emtricitabine (FTC) and tenofovir DF (TDF)

ritonavir-boosted atazanavir in combination with emtricitabine (FTC) and tenofovir DF (TDF)

Outcomes

Primary Outcome Measures

Treatment Response at Week 48

Treatment response is defined as a viral load (VL) <50 copies/mL measured at two consecutive visits prior to Week 48 and without subsequent rebound or change of antiretroviral (ARV) therapy prior to Week 48.

Secondary Outcome Measures

Treatment Response at Week 48 (TLOVR Algorithm)

Treatment response is defined as a VL <50 copies/mL measured at two consecutive visits up to Week 48 and without subsequent rebound or change of ARV therapy up to Week 48, based on time to loss of virologic response (TLOVR) algorithm, as a sensitivity analysis for the primary analysis.

Proportion of Patients With VL < 50 Copies/ml

VL <50 copies/mL among observed patients on treatment at each visit, with the final visit at Week 144 or end of trial (EOT) for the patient

Proportion of Patients With VL < 400 Copies/ml

VL <400 copies/mL among observed patients on treatment at each visit, with the final visit at Week 144 or end of trial (EOT)

Change in CD4+ Count From Baseline

Change in CD4+ cell count from baseline among patients on treatment at each visit, with the final visit at Week 144 or EOT

Change in Framingham Score From Baseline

Change in the estimated risk of cardiovascular disease using the Framingham algorithm from baseline to after 48, 96 and 144 weeks, last observation carried forward (LOCF). The score is based on age, gender, systolic blood pressure, total cholesterol, high density lipoprotein cholesterol and smoking status. Scores range from 0 to 21 with higher scores indicating a greater risk.

Change in Mental Health Summary (MHS) Score From Baseline

Quality of life (QoL) assessment by change in MHS score from baseline to after 48, 96 and 144 weeks (observed cases), from the Medical Outcomes Study HIV Health Survey (MOS-HIV), a 35-item self-administered questionnaire including 10 scales covering: health perceptions, pain, physical functioning, role functioning, social and cognitive functioning, mental health, energy/fatigue, health distress, and QoL. The MHS is a weighted average of the 10 scales and ranges from 0 to 100 with higher scores indicating better QoL.

Change in Physical Health Summary (PHS) Score From Baseline

QoL assessment by change in PHS score from baseline to after 48, 96 and 144 weeks (observed cases), from the MOS-HIV, a 35-item self-administered questionnaire including 10 scales covering: health perceptions, pain, physical functioning, role functioning, social and cognitive functioning, mental health, energy/fatigue, health distress, and QoL. The PHS is a weighted average of the 10 scales and ranges from 0 to 100 with higher scores indicating better QoL.

Number of Patients Hospitalized

Cost effectiveness assessment by number of patients hospitalized

Non-scheduled Physician Visits

Cost effectiveness assessment by number of patients with non-scheduled physician visits

Genotypic Resistance Associated With Virologic Failure

Number of treatment-emergent drug-associated substitutions in patients with virological failure up to Week 48. The total number of genotypic mutations in those patients who were virologic failures is given, not the number of patients with mutations.

Treatment-emergent AIDS-defining Illness

Treatment-emergent AIDS-defining illness (tr.-emerg. AIDS-def.illness) including worsening during treatment

Treatment-emergent AIDS-defining Illness Leading to Death

Patients with an AIDS-defining illness leading to death broken out by treatment. Statistical analysis shows time to death from AIDS-defining illness.

Lipodystrophy

Number of patients with AE lipodystrophy

Serum Lipid Abnormalities

Number of patients with AE elevated serum lipids (i.e. hypercholesterolaemia)

Glycaemic Abnormalities

Number of patients with AE elevated serum glucose

Treatment Response at Week 96

Treatment response is defined as a viral load (VL) <50 copies/mL measured at two consecutive visits prior to Week 96 and without subsequent rebound or change of antiretroviral (ARV) therapy prior to Week 96.

Treatment Response at Week 144

Treatment response is defined as a viral load (VL) <50 copies/mL measured at two consecutive visits prior to Week 144 and without subsequent rebound or change of antiretroviral (ARV) therapy prior to Week 144.

Proportion of Patients With Virological Rebound With VL >=50 Copies/mL After CVR (Confirmed Virological Response) at Week 24, 48, 96, 144

The analyses of virologic rebound were performed on the original values at each visit(ORGV) rather than calculated results within time windows (CAL)

Proportion of Patients With Virological Rebound With VL >=400 Copies/mL After CVR at Week 24, 48, 96, 144

The analyses of virologic rebound were performed on the original values at each visit(ORGV) rather than calculated results within time windows (CAL)

Proportion of Patients With Virologic Failure at Week 48, 96, 144

Time to Treatment Response (First Confirmed VL<50 Copies/mL)

Time to treatment response was defined as the time from start of treatment until the first measurement of the first confirmed virological response

Time to Loss of Virologic Response (Rebound)

Time to loss of virologic response (TLOVR) was defined as the time from start of treatment to the first measurement showing VL ≥ 50 copies/mL in the first virologic rebound, after having a confirmed virological response.

Time to Treatment Failure

Treatment failure is defined as the occurrence of the first of at least one of the following events: early discontinuation of trial drug, change in ARV therapy, failure to achieve an HIV RNA count < 50 copies/mL up to Visit 10 (week 48) or loss of virologic response

Change in the Calculated Glomerular Filtration Rate (GFR) at Week 48, 96 and 144

Calculations based on the MDRD algorithm.

Proportion of Patients With >= DAIDS Grade 2 Laboratory Abnormalities

Proportion of Patients Reporting Rash of Any Severity

Proportion of Patients reporting rash of any severity

Proportion of Patients Reporting Hepatic Events of Any Severity

Proportion of Patients reporting hepatic events of any severity

Proportion of Patients Reporting CNS (Central Nervous System) Side Effects of Any Severity

Proportion of Patients reporting CNS (central nervous system) side effects of any severity

Change of Cholesterol Values From Baseline to Week 48, 96, 144

Changes frombaseline in total cholesterol, LDL-cholesterol(LDL-c) and HDL

Changes of Apolipoprotein Values From Baseline to Week 48, 96, 144

Changes frombaseline apolipoprotein A1 & B

Change of hsCRP From Baseline to Week 48, 96, 144

Change of hsCRP from baseline to week 48, 96, 144

Change of Total Triglycerides From Baseline to Week 48, 96, 144

Change of total triglycerides from baseline to week 48, 96, 144

Change of Total Cholesterol to HDL-cholesterol Ratio From Baseline to Week 48, 96, 144

Change of Total cholesterol to HDL-cholesterol ratio from baseline to week 48, 96, 144

Full Information

NCT ID

NCT00389207

First Posted

October 17, 2006

Last Updated

December 9, 2013

Sponsor

Boehringer Ingelheim

1. Study Identification

Unique Protocol Identification Number

NCT00389207

Brief Title

Nevirapine or Atazanavir/Ritonavir Given With Emtricitabine/Tenofovir in Human Immunodeficiency Virus (HIV)-1-infected Treatment Naive Adults

Official Title

Randomized, Open Label Study Evaluating the Lipid Profile Difference and Efficacy of a Combined Therapy Including Tenofovir, Emtricitabine + Atazanavir / r or NVP in Naive HIV - 1 Infected Patients.

Study Type

Interventional

2. Study Status

Record Verification Date

December 2013

Overall Recruitment Status

Completed

Study Start Date

October 2006 (undefined)

Primary Completion Date

February 2011 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Boehringer Ingelheim

4. Oversight

5. Study Description

Brief Summary

Primary purpose of this study is to compare the efficacy and safety of two different nevirapine (Viramune) dosing regimens (once daily (QD) and twice daily (BID) application) and of atazanavir/ritonavir (Reyataz/Norvir), all on an emtricitabine/tenofovir disoproxil fumarate (DF) (Truvada) background. Patients will receive either nevirapine (NVP) 200 mg twice daily, or NVP 400 mg once daily , or ritonavir-boosted atazanavir (ATZ/r), all in combination with emtricitabine (FTC) and tenofovir DF (TDF). All patients receiving NVP will start at 200 mg once daily for 2 weeks, because it has been demonstrated that this lead-in dosing regimen reduces the frequency of NVP-induced rash. At Visit 3 (Week 2), patients increase the NVP dose to either 200 mg twice daily or to 400 mg once daily. Patients receiving ATZ/r will be treated with ATZ 300 mg once daily, boosted by 100 mg ritonavir (RTV) once daily. Background antiretroviral therapy for all patients consists of one tablet of Truvada. Treatment duration is 48 weeks (primary endpoint) with an extension to 144 weeks. Patients may also participate in the metabolic sub-study, comparing NVP and ATZ/r for signs and symptoms of lipodystrophy and serum lipid/glycaemic abnormalities.

6. Conditions and Keywords

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

HIV Infections

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

576 (Actual)

8. Arms, Groups, and Interventions

Arm Title

NVP bid

Arm Type

Active Comparator

Arm Description

nevirapine (NVP) 200 mg BID in combination with emtricitabine (FTC) and tenofovir DF (TDF)

Arm Title

NVP qd

Arm Type

Experimental

Arm Description

nevirapine (NVP) 400 mg QD in combination with emtricitabine (FTC) and tenofovir DF (TDF)

Arm Title

ATZ/r

Arm Type

Active Comparator

Arm Description

ritonavir-boosted atazanavir in combination with emtricitabine (FTC) and tenofovir DF (TDF)

Intervention Type

Drug

Intervention Name(s)

nevirapine bid

Intervention Description

nevirapine twice daily

Intervention Type

Drug

Intervention Name(s)

nevirapine qd

Intervention Description

nevirapine once daily

Intervention Type

Drug

Intervention Name(s)

atazanavir

Intervention Description

atazanavir once daily

Primary Outcome Measure Information:

Title

Treatment Response at Week 48

Description

Time Frame

From baseline to Week 48

Secondary Outcome Measure Information:

Title

Treatment Response at Week 48 (TLOVR Algorithm)

Description

Time Frame

From baseline to Week 48

Title

Proportion of Patients With VL < 50 Copies/ml

Description

VL <50 copies/mL among observed patients on treatment at each visit, with the final visit at Week 144 or end of trial (EOT) for the patient

Time Frame

From baseline to Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132 and 144/EOT

Title

Proportion of Patients With VL < 400 Copies/ml

Description

VL <400 copies/mL among observed patients on treatment at each visit, with the final visit at Week 144 or end of trial (EOT)

Time Frame

From baseline to Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132 and 144/EOT

Title

Change in CD4+ Count From Baseline

Description

Change in CD4+ cell count from baseline among patients on treatment at each visit, with the final visit at Week 144 or EOT

Time Frame

From baseline to Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132 and 144/EOT

Title

Change in Framingham Score From Baseline

Description

Time Frame

From baseline to Weeks 48, 96 and 144/EOT

Title

Change in Mental Health Summary (MHS) Score From Baseline

Description

Time Frame

From baseline to Weeks 48, 96 and 144/EOT

Title

Change in Physical Health Summary (PHS) Score From Baseline

Description

Time Frame

From baseline to Weeks 48, 96 and 144/EOT

Title

Number of Patients Hospitalized

Description

Cost effectiveness assessment by number of patients hospitalized

Time Frame

From baseline to Week 24, Week 24 to 48, Week 48 to 96, and Week 96 to 144/EOT

Title

Non-scheduled Physician Visits

Description

Cost effectiveness assessment by number of patients with non-scheduled physician visits

Time Frame

From baseline to Week 24, Week 24 to 48, Week 48 to 96, and Week 96 to 144/EOT

Title

Genotypic Resistance Associated With Virologic Failure

Description

Time Frame

From baseline to Week 48

Title

Treatment-emergent AIDS-defining Illness

Description

Treatment-emergent AIDS-defining illness (tr.-emerg. AIDS-def.illness) including worsening during treatment

Time Frame

From baseline to Week 144

Title

Treatment-emergent AIDS-defining Illness Leading to Death

Description

Patients with an AIDS-defining illness leading to death broken out by treatment. Statistical analysis shows time to death from AIDS-defining illness.

Time Frame

From baseline to Week 144

Title

Lipodystrophy

Description

Number of patients with AE lipodystrophy

Time Frame

From baseline to Week 144

Title

Serum Lipid Abnormalities

Description

Number of patients with AE elevated serum lipids (i.e. hypercholesterolaemia)

Time Frame

From baseline to Week 144

Title

Glycaemic Abnormalities

Description

Number of patients with AE elevated serum glucose

Time Frame

From baseline to Week 144

Title

Treatment Response at Week 96

Description

Time Frame

From baseline to Week 96

Title

Treatment Response at Week 144

Description

Time Frame

From baseline to Week 144

Title

Proportion of Patients With Virological Rebound With VL >=50 Copies/mL After CVR (Confirmed Virological Response) at Week 24, 48, 96, 144

Description

The analyses of virologic rebound were performed on the original values at each visit(ORGV) rather than calculated results within time windows (CAL)

Time Frame

at Week 24, 48, 96, 144

Title

Proportion of Patients With Virological Rebound With VL >=400 Copies/mL After CVR at Week 24, 48, 96, 144

Description

The analyses of virologic rebound were performed on the original values at each visit(ORGV) rather than calculated results within time windows (CAL)

Time Frame

at Week 24, 48, 96, 144

Title

Proportion of Patients With Virologic Failure at Week 48, 96, 144

Time Frame

at Week 48, 96, 144

Title

Time to Treatment Response (First Confirmed VL<50 Copies/mL)

Description

Time to treatment response was defined as the time from start of treatment until the first measurement of the first confirmed virological response

Time Frame

baseline to week 144

Title

Time to Loss of Virologic Response (Rebound)

Description

Time Frame

Baseline to week 144

Title

Time to Treatment Failure

Description

Time Frame

baseline to week 144

Title

Change in the Calculated Glomerular Filtration Rate (GFR) at Week 48, 96 and 144

Description

Calculations based on the MDRD algorithm.

Time Frame

From baseline to Week 48, 96, 144

Title

Proportion of Patients With >= DAIDS Grade 2 Laboratory Abnormalities

Time Frame

week 148

Title

Proportion of Patients Reporting Rash of Any Severity

Description

Proportion of Patients reporting rash of any severity

Time Frame

week 148

Title

Proportion of Patients Reporting Hepatic Events of Any Severity

Description

Proportion of Patients reporting hepatic events of any severity

Time Frame

week 148

Title

Proportion of Patients Reporting CNS (Central Nervous System) Side Effects of Any Severity

Description

Proportion of Patients reporting CNS (central nervous system) side effects of any severity

Time Frame

week 148

Title

Change of Cholesterol Values From Baseline to Week 48, 96, 144

Description

Changes frombaseline in total cholesterol, LDL-cholesterol(LDL-c) and HDL

Time Frame

baseline to week 48, 96, 144

Title

Changes of Apolipoprotein Values From Baseline to Week 48, 96, 144

Description

Changes frombaseline apolipoprotein A1 & B

Time Frame

baseline to week 48, 96, 144

Title

Change of hsCRP From Baseline to Week 48, 96, 144

Description

Change of hsCRP from baseline to week 48, 96, 144

Time Frame

baseline to week 48, 96, 144

Title

Change of Total Triglycerides From Baseline to Week 48, 96, 144

Description

Change of total triglycerides from baseline to week 48, 96, 144

Time Frame

baseline to week 48, 96, 144

Title

Change of Total Cholesterol to HDL-cholesterol Ratio From Baseline to Week 48, 96, 144

Description

Change of Total cholesterol to HDL-cholesterol ratio from baseline to week 48, 96, 144

Time Frame

baseline to week 48, 96, 144

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria: Inclusion Criteria: Signed informed consent in accordance with Good Clinical Practice (GCP) and local regulatory requirements prior to trial participation HIV-1-infected males or females >= 18 years of age with positive serology confirmed by Western blot No previous antiretroviral treatment (of more than 7 days) Males with CD4+ counts of < 400 cells/mm3 and females with CD4+ counts of < 250 cells/mm3 NVP- and ATZ/r susceptibility based on HIV-1 genotypic resistance report Adequate renal function defined as a calculated creatinine clearance (CLCr) >= 50 ml/min according to the Cockcroft-Gault formula Karnofsky score >= 70 Acceptable medical history, as assessed by the investigator Exclusion criteria: Exclusion Criteria: Active drug abuse or chronic alcoholism at the investigator's discretion Hepatic cirrhosis stage Child-Pugh B or C Female patients of child-bearing potential who: have a positive serum pregnancy test at screening or during the study, are breast feeding, are planning to become pregnant, are not willing to use a barrier method of contraception, or are not willing to use methods of contraception other than ethinyl estradiol containing oral contraceptives Laboratory parameters Division of Acquired Immunodeficiency Syndrome (DAIDS) > grade 2 (triglycerides > DAIDS grade 3; total cholesterol no restrictions) Active hepatitis B or C disease, defined as HBsAg-positive or Hepatitis C-Virus-Ribo Nucleic Acid (HCV-RNA)- positive with Aspartate Transaminase/Alanine Transaminase (AST/ALT) > 2.5x Upper Limit of Normal (ULN) (DAIDS grade 1) Hypersensitivity to any ingredients of the test products Have therapy with nephrotoxic drugs (e.g., aminoglycosides, amphotericin B, vancomycin, cidofovir, foscarnet, cisplatin, pentamidine, tacrolimus, cyclosporine) or potential competitors of renal excretion (e.g., cidofovir, acyclovir, valacyclovir, ganciclovir, valganciclovir, probenecid, high-dose non-steroidal anti-inflammatory drugs (i.e., ibuprofen)) within 3 months prior to study screening or are expected to receive these during the study Patients who are receiving other concomitant treatments which are not permitted Use of other investigational medications within 30 days before study entry or during the trial Use of immunomodulatory drugs within 30 days before study entry or during the trial (e.g., interferon, cyclosporin, hydroxyurea, interleukin 2, chronic treatment with prednisone) Patients with Progressive Multifocal Leukoencephalopathy (PML), Visceral Kaposi's Sarcoma (KS), and/or any lymphoma Any AIDS defining illness that is unresolved, symptomatic or not stable on treatment for at least 12 weeks at screening visit Patients who are receiving systemic treatment for malignant disease

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Boehringer Ingelheim

Organizational Affiliation

Boehringer Ingelheim

Official's Role

Study Chair

Facility Information:

Facility Name

1100.1470.54004 Boehringer Ingelheim Investigational Site

City

Capital Federal

Country

Argentina

Facility Name

1100.1470.54002 Boehringer Ingelheim Investigational Site

City

Córdoba

Country

Argentina

Facility Name

1100.1470.54003 Boehringer Ingelheim Investigational Site

City

Mar del Plata

Country

Argentina

Facility Name

1100.1470.54001 Boehringer Ingelheim Investigational Site

City

Rosario

Country

Argentina

Facility Name

1100.1470.49001 Boehringer Ingelheim Investigational Site

City

Berlin

Country

Germany

Facility Name

1100.1470.49002 Boehringer Ingelheim Investigational Site

City

Berlin

Country

Germany

Facility Name

1100.1470.49003 Boehringer Ingelheim Investigational Site

City

Bochum

Country

Germany

Facility Name

1100.1470.49018 Boehringer Ingelheim Investigational Site

City

Bonn

Country

Germany

Facility Name

1100.1470.49014 Boehringer Ingelheim Investigational Site

City

Düsseldorf

Country

Germany

Facility Name

1100.1470.49008 Boehringer Ingelheim Investigational Site

City

Erlangen

Country

Germany

Facility Name

1100.1470.49036 Boehringer Ingelheim Investigational Site

City

Frankfurt am Main

Country

Germany

Facility Name

1100.1470.49035 Boehringer Ingelheim Investigational Site

City

Frankfurt

Country

Germany

Facility Name

1100.1470.49033 Boehringer Ingelheim Investigational Site

City

Freiburg/Breisgau

Country

Germany

Facility Name

1100.1470.49016 Boehringer Ingelheim Investigational Site

City

Hamburg

Country

Germany

Facility Name

1100.1470.49031 Boehringer Ingelheim Investigational Site

City

Hamburg

Country

Germany

Facility Name

1100.1470.49037 Boehringer Ingelheim Investigational Site

City

Hamburg

Country

Germany

Facility Name

1100.1470.49020 Boehringer Ingelheim Investigational Site

City

Hannover

Country

Germany

Facility Name

1100.1470.49038 Boehringer Ingelheim Investigational Site

City

Magdeburg

Country

Germany

Facility Name

1100.1470.49034 Boehringer Ingelheim Investigational Site

City

München

Country

Germany

Facility Name

1100.1470.49000 Boehringer Ingelheim Investigational Site

City

Ulm

Country

Germany

Facility Name

1100.1470.49032 Boehringer Ingelheim Investigational Site

City

Würzburg

Country

Germany

Facility Name

1100.1470.39001 Boehringer Ingelheim Investigational Site

City

Bergamo

Country

Italy

Facility Name

1100.1470.39003 Boehringer Ingelheim Investigational Site

City

Bologna

Country

Italy

Facility Name

1100.1470.39012 Ospedale Sant'Anna

City

Como

Country

Italy

Facility Name

1100.1470.39006 Boehringer Ingelheim Investigational Site

City

Ferrara

Country

Italy

Facility Name

1100.1470.39010 Boehringer Ingelheim Investigational Site

City

Lecco

Country

Italy

Facility Name

1100.1470.39004 Boehringer Ingelheim Investigational Site

City

Torino

Country

Italy

Facility Name

1100.1470.39009 Boehringer Ingelheim Investigational Site

City

Torrette Di Ancona

Country

Italy

Facility Name

1100.1470.39007 Boehringer Ingelheim Investigational Site

City

Varese

Country

Italy

Facility Name

1100.1470.55006 Boehringer Ingelheim Investigational Site

City

Aguascalientes

Country

Mexico

Facility Name

1100.1470.55004 Boehringer Ingelheim Investigational Site

City

Col Obregón

Country

Mexico

Facility Name

1100.1470.55008 Boehringer Ingelheim Investigational Site

City

Col. Los Filtros, San Luis Potosí

Country

Mexico

Facility Name

1100.1470.55001 Boehringer Ingelheim Investigational Site

City

Col. Toriello Guerra

Country

Mexico

Facility Name

1100.1470.55007 Boehringer Ingelheim Investigational Site

City

Guadalajara Jal.

Country

Mexico

Facility Name

1100.1470.55003 Boehringer Ingelheim Investigational Site

City

Tlalpan-México D,F

Country

Mexico

Facility Name

1100.1470.48003 Boehringer Ingelheim Investigational Site

City

Bydgoszcz

Country

Poland

Facility Name

1100.1470.48001 Boehringer Ingelheim Investigational Site

City

Chorzow

Country

Poland

Facility Name

1100.1470.48002 Boehringer Ingelheim Investigational Site

City

Szczecin

Country

Poland

Facility Name

1100.1470.48004 Boehringer Ingelheim Investigational Site

City

Warsaw

Country

Poland

Facility Name

1100.1470.35102 Boehringer Ingelheim Investigational Site

City

Cascais

Country

Portugal

Facility Name

1100.1470.35101 Boehringer Ingelheim Investigational Site

City

Lisboa

Country

Portugal

Facility Name

1100.1470.35103 Boehringer Ingelheim Investigational Site

City

Porto

Country

Portugal

Facility Name

1100.1470.40001 Boehringer Ingelheim Investigational Site

City

Bucharest

Country

Romania

Facility Name

1100.1470.40002 Boehringer Ingelheim Investigational Site

City

Bucharest

Country

Romania

Facility Name

1100.1470.34013 Boehringer Ingelheim Investigational Site

City

Alcalá de Henares (Madrid)

Country

Spain

Facility Name

1100.1470.34008 Boehringer Ingelheim Investigational Site

City

Badalona

Country

Spain

Facility Name

1100.1470.34002 Boehringer Ingelheim Investigational Site

City

Barcelona

Country

Spain

Facility Name

1100.1470.34003 Boehringer Ingelheim Investigational Site

City

Barcelona

Country

Spain

Facility Name

1100.1470.34009 Boehringer Ingelheim Investigational Site

City

L'Hospitalet de Llobregat

Country

Spain

Facility Name

1100.1470.34010 Boehringer Ingelheim Investigational Site

City

Madrid

Country

Spain

Facility Name

1100.1470.34012 Boehringer Ingelheim Investigational Site

City

Madrid

Country

Spain

Facility Name

1100.1470.34014 Boehringer Ingelheim Investigational Site

City

Madrid

Country

Spain

Facility Name

1100.1470.34015 Boehringer Ingelheim Investigational Site

City

Madrid

Country

Spain

Facility Name

1100.1470.34019 Boehringer Ingelheim Investigational Site

City

Malaga

Country

Spain

Facility Name

1100.1470.34007 Boehringer Ingelheim Investigational Site

City

Sabadell (Barcelona)

Country

Spain

Facility Name

1100.1470.34004 Boehringer Ingelheim Investigational Site

City

San Sebastian

Country

Spain

Facility Name

1100.1470.34006 Boehringer Ingelheim Investigational Site

City

Santa Cruz de Tenerife

Country

Spain

Facility Name

1100.1470.34011 Boehringer Ingelheim Investigational Site

City

Vigo

Country

Spain

Facility Name

1100.1470.41004 Boehringer Ingelheim Investigational Site

City

Bern

Country

Switzerland

Facility Name

1100.1470.41001 Boehringer Ingelheim Investigational Site

City

Lugano

Country

Switzerland

Facility Name

1100.1470.41003 Boehringer Ingelheim Investigational Site

City

St. Gallen

Country

Switzerland

Facility Name

1100.1470.41002 Boehringer Ingelheim Investigational Site

City

Zürich

Country

Switzerland

Facility Name

1100.1470.44004 Boehringer Ingelheim Investigational Site

City

Birmingham

Country

United Kingdom

Facility Name

1100.1470.44001 Boehringer Ingelheim Investigational Site

City

London

Country

United Kingdom

Facility Name

1100.1470.44002 Boehringer Ingelheim Investigational Site

City

London

Country

United Kingdom

Facility Name

1100.1470.44005 Boehringer Ingelheim Investigational Site

City

London

Country

United Kingdom

Facility Name

1100.1470.44006 Boehringer Ingelheim Investigational Site

City

London

Country

United Kingdom

Facility Name

1100.1470.44003 Boehringer Ingelheim Investigational Site

City

Manchester

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

21628668

Citation

Seclen E, Soriano V, Gonzalez MM, Martin-Carbonero L, Gellermann H, Distel M, Kadus W, Poveda E. Impact of baseline HIV-1 tropism on viral response and CD4 cell count gains in HIV-infected patients receiving first-line antiretroviral therapy. J Infect Dis. 2011 Jul 1;204(1):139-44. doi: 10.1093/infdis/jir218.

Results Reference

derived

PubMed Identifier

21555816

Citation

Soriano V, Arasteh K, Migrone H, Lutz T, Opravil M, Andrade-Villanueva J, Antunes F, Di Perri G, Podzamczer D, Taylor S, Domingo P, Gellermann H, de Rossi L; ARTEN investigators. Nevirapine versus atazanavir/ritonavir, each combined with tenofovir disoproxil fumarate/emtricitabine, in antiretroviral-naive HIV-1 patients: the ARTEN Trial. Antivir Ther. 2011;16(3):339-48. doi: 10.3851/IMP1745.

Results Reference

derived

Links:

URL

http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1100/1100.1470_U11-2659.pdf

Description

Related Info

Learn more about this trial

Nevirapine or Atazanavir/Ritonavir Given With Emtricitabine/Tenofovir in Human Immunodeficiency Virus (HIV)-1-infected Treatment Naive Adults

We'll reach out to this number within 24 hrs

Nevirapine or Atazanavir/Ritonavir Given With Emtricitabine/Tenofovir in Human Immunodeficiency Virus (HIV)-1-infected Treatment Naive Adults

HIV Infections

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

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