Zidovudine / Lamivudine + Nevirapine Twice Daily, Versus Tenofovir + Lamivudine + Nevirapine Once Daily in ARV-Naive Patients
Hiv Infection With Antiretroviral Therapy Indication, CD4 Below 350/µL or Below 15%
About this trial
This is an interventional treatment trial for Hiv Infection With Antiretroviral Therapy Indication focused on measuring Antiretroviral Therapy, Nevirapine, HIV Viral Load, Adherence, Quality of Life, Resistance Mutations
Eligibility Criteria
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
Sites / Locations
- Cisih, Clinique Medical A, Hopitaux UniversitairesRecruiting