Project no.: HIV-NAT 001.1
Study Endpoint:
- Primary:
- Percentage of patients achieving sustained undetectable HIV-1 RNA in plasma (Amplicor HIV-1 Moniror) at 48 weeks
- Degree and duration of increase in CD4+ cell counts from baseline
- Secondary: Development of, or delay in development of, genotypic markers of reduced viral sensitivity to the study drugs
Study design:
- All patients successfully completing 48 weeks of follow-up in study protocal 001 received open label AZT/ddC in standard doses for another 18 weeks in an ‘extension phase’ of study 001.
- After a total of 66 weeks on study 001, they were switched to this study (001.1)
- Participants monitored at baseline (week 66), weeks 70, 74, and every 8 weeks thereafter
Result: A formal, interim analysis is currently in progress (Jan 1999)