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

MEDEX

Status and phase

Unknown

Phase 3

Conditions

Hiv Infection With Antiretroviral Therapy Indication

CD4 Below 350/µL or Below 15%

Treatments

Drug: Nevirapine

Study type

Interventional

Funder types

Other

Identifiers

NCT00199979

DAUFIN

Details and patient eligibility

About

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.

Full description

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

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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