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

Launched by MEDEX · Sep 12, 2005

Keywords

ClinConnect Summary

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

Gender

ALL

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