Status:
UNKNOWN
Zidovudine / Lamivudine + Nevirapine Twice Daily, Versus Tenofovir + Lamivudine + Nevirapine Once Daily in ARV-Naive Patients
Lead Sponsor:
MEDEX
Conditions:
Hiv Infection With Antiretroviral Therapy Indication
CD4 Below 350/µL or Below 15%
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 combin...
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
- 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
- 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
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
End Date :
June 1 2008
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT00199979
Start Date
April 1 2005
End Date
June 1 2008
Last Update
December 16 2005
Active Locations (1)
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1
Cisih, Clinique Medical A, Hopitaux Universitaires
Strasbourg, Alsace, France, 67091