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

• Status: Unknown status
• Trial end date: 2008-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: MEDEX
• Treatments: Lamivudine; Nevirapine; Tenofovir; Zidovudine

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