Clinical trial NCT00199979: Zidovudine / Lamivudine + Nevirapine Twice Daily, Versus Tenofovir + Lamivudine + Nevirapine Once Daily in ARV-Naive Patients
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Hiv Infection With Antiretroviral Therapy Indication
CD4 Below 350/µL or Below 15%
Keywords: Antiretroviral Therapy
Nevirapine
HIV Viral Load
Adherence
Quality of Life
Resistance Mutations
Lead sponsor: MEDEX
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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

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

Primary outcomes:
measure: 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).
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Cisih, Clinique Medical A, Hopitaux Universitaires
state: Alsace
Study officials:
affiliation: CISIH CHRU STRASBOURG
name: REY MR DAVID, M.D
role: PRINCIPAL_INVESTIGATOR
References: