Project no.: HIV-NAT 006
Introduction:
- Hydroxyurea (HU) blocks DNA synthesis by inhibitoion of the cellular enzyme ribonucleotide reductase. It has been shown in vitro to block HIV-1 infection in acutely infected human lymphocytes and macrophages. In vitro synergy with ddI has also been demonstrated
- Nevirapine, the first drug developed in the non-nucleoside class, has been shown to have beneficial effects on CD cell counts and HIV-1 viral load when given with combination nucleoside antiretroviral regimens
Study Regimens:
- ddI + d4T
- ddI + d4T + hydroxyurea
- ddI + d4T + nevirapine
- ddI + d4T + nevirapine + hydroxyurea
Study Objectives:
- Primary:
- To compare the time weighted change in plasma HIV-1 RNA load from baseline in each arm as a measure of relative efficacy
- To access safety and tolerance of the four different regimens based in clinical and laboratory adverse events
- Secondary:
- To evaluate the time weighted changed in absolute CD4+ cell counts and CD4/CD8 ratio from baseline in each regimens
- To access efficacy of the different regimens on survival and HIV disease progression
Study Design:
- Total of 200 antiretroviral naïve participants will be recruited over a 6 month period and equally randomized to one of the four study arms
- Participants should have CD4+ cell count of at least 150 cells/nn3 and HIV-RNA viral load of at least 10,000 copies/ml
- Duration of study is 48 weeks