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

Sponsor

MEDEX (Other)

Overall Status

Unknown status

CT.gov ID

NCT00199979

Collaborator

(none)

250

Enrollment

Location

Duration (Months)

6.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hiv Infection With Antiretroviral Therapy Indication CD4 Below 350/µL or Below 15%	Drug: Nevirapine	Phase 3

Detailed Description

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

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Apr 1, 2005

Study Completion Date :

Jun 1, 2008

Outcome Measures

Primary Outcome Measures

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). []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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