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

Condition(s) targeted: Hiv Infection With Antiretroviral Therapy Indication; CD4 Below 350/µL or Below 15%

Intervention: Nevirapine (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: MEDEX

Official(s) and/or principal investigator(s):
REY MR DAVID, M.D, Principal Investigator, Affiliation: CISIH CHRU STRASBOURG

Overall contact:
REY DAVID, M.D, Phone: 0388116451, Ext: 33, Email: david.rey@chru-strasbourg.fr

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.

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: 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).

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

REY DAVID, M.D, Phone: 0388116451, Ext: 33, Email: david.rey@chru-strasbourg.fr

Cisih, Clinique Medical A, Hopitaux Universitaires, Strasbourg, Alsace 67091, France; Recruiting
REY DAVID, M.D, Phone: 0388116333, Ext: 33, Email: david.rey@chru-strasbourg.fr
REY DAVID, M.D, Principal Investigator

Starting date: April 2005
Last updated: December 15, 2005