Zidovudine / Lamivudine + Nevirapine Twice Daily, Versus Tenofovir + Lamivudine + Nevirapine Once Daily in ARV-Naive Patients

Study Overview
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Brief Summary
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The study will compare the immuno-virological efficacy, and safety, of a once daily antiretroviral combination (tenofovir + lamivudine + nevirapine) versus a twice daily association (fixed dose combination of zidovudine/lamivudine + nevirapine) in ARV-Naive HIV-1 infected subjects, with CD4 cell count below 350/µL or below 15%, whatever the viral load. Pharmacological (nevirapine concentrations) and virologic data (resistance mutations in case of failure) will also be provided, as well as adherence rate and quality of life in respect of the treatment arms.

Detailed Description
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96-week antiviral efficacy of tenofovir + lamivudine + nevirapine, once daily, versus a reference antiretroviral treatment given twice daily (zidovudine/lamivudine + nevirapine)

Official Title
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Multicenter, Randomized, Open-Label Trial, Assessing the Efficacy of Zidovudine, Lamivudine and Nevirapine Combination Administered Twice Daily, Versus the Association of Tenofovir, Lamivudine and Nevirapine, Once Daily, in Antiretroviral Naive HIV-1 Infected Patients

Conditions
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Hiv Infection With Antiretroviral Therapy Indication, CD4 Below 350/µL or Below 15%

Intervention / Treatment
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* Drug: Nevirapine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: HIV-1 infection, confirmed by a western-blot assay, at least 6 months after primary infection Age > or equal to 18 years of age No prior antiretroviral treatment Karnofsky superior to 60% CD4 T cells < 350/µL (2 measures, with at least a 1-month interval) in women, study will be proposed when CD4 cell count is below 250/µL, as nevirapine liver toxicity increases (X10) when CD4 are > 250/µL Written informed consent Exclusion Criteria: HIV-2 infection or co-infection Prior antiretroviral treatment Intolerance, or contraindication to investigational drugs Pregnant or breast-feeding woman, or plan to become pregnant Active untreated opportunistic infections (AIDS-defining illness, category C, CDC, 1993), or malignancies requiring cytotoxic chemotherapy Biological criteria: hemoglobin < 10 G/DL, neutrophil count < 1000/µL, platelets < 50000/µL, creatinine > 2N, ASAT or ALAT > 2.5N, bilirubin > 2N, hypophosphatemia Prevision of poor adherence HBC co-infection (Ag Hbs positive) or HVC co-infection (positive HCV PCR) Liver failure, alcohol abuse Treatment administration not recommended with investigational drugs Interferon, interleukin, or HIV vaccine treatment Informed consent not obtained

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Nevirapine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the antiviral efficacy of AZT, 3TC, and NVP combination, in two doses per day, to the association of TDF, 3TC, and NVP, once a day, in antiretroviral naive HIV-1-infected patients (plasma viral load below 400 copies/ml at 96 weeks). |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Antiretroviral Therapy, Nevirapine, HIV Viral Load, Adherence, Quality of Life, Resistance Mutations