Conditions: HIV/AIDS
Keywords: HIV;Bioequivalence;Triomune
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 20
Healthy volunteers: no

Brief summary:
The null hypothesis is that there is a difference in the the relative rate and extent of absorption into the systemic circulation of Triomune and brand-name Stavudine/Lamivudine/Nevirapine in HIV-infected Africans and the alternative hypothesis is that there is no difference in the the relative rate and extent of absorption into the systemic circulation of Triomune and brand-name Stavudine/Lamivudine/Nevirapine in HIV-infected Africans. This is a non-inferiority study.

Detailed description:
Generic antiretroviral therapy is the mainstay of HIV treatment in resource-limited settings, yet there is little evidence confirming the bioequivalence of generic and brand name formulations. We compared the steady-state pharmacokinetics of Lamivudine, Stavudine and Nevirapine in HIV-infected subjects who were receiving a generic formulation (Triomune®) or the corresponding brand formulations (Epivir®, Zerit®, and Viramune®). An open-label, randomized, crossover study was carried out in 18 HIV-infected Ugandan subjects stabilized on Triomune-40. Subjects received Lamivudine (150 mg), Stavudine (40 mg), and Nevirapine (200 mg) in either the generic or brand formulation twice a day for 30 days, before switching to the other formulation. At the end of each treatment period, blood samples were collected over 12 h for pharmacokinetic analysis. The main outcome measures were the mean AUC0-12h and Cmax. Bioequivalence was defined as a geometric mean ratio between the generic and brand-name within the 90% confidence interval of 0.8-1.25.

Arms:
arm 1: generic fixed dose combination of Stavudine, Lamivudine and Nevirapine (Triomune) arm 2: 3 separate single pills of Zerit (Stavudine)Epivir (Lamivudine) Viramune (Nevirapine)

Interventions: intervention 1: Triomune intervention 2: Zerit/Epivir/Viramune
Intervention descriptions: intervention 1: Stavudine (40mg) Lamivudine (150mg) Nevirapine (200mg)All twice a day intervention 2: Stavudine (40mg) Lamivudine (150mg) and Nevirapine (200mg) All taken twice daily.

Protocol document: