Trial | NCT00199979  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    nevirapine ...

  • Study Participants

    250
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.
96-week antiviral efficacy of tenofovir + lamivudine + nevirapine, once daily, versus a reference antiretroviral treatment given twice daily (zidovudine/lamivudine + nevirapine)
Study Started
Apr 30
2005
Study Completion
Jun 30
2008
Last Update
Dec 16
2005
Estimate

Drug Nevirapine

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
No Results Posted