A Study of 141W94 Used Alone or in Combination With Zidovudine Plus 3TC in HIV-Infected Patients
Status:
Completed
Trial end date:
1998-09-01
Target enrollment:
Participant gender:
Summary
To determine the proportion of patients whose plasma HIV-1 RNA level remains below a
detectable level (less than 500/ml) after 24 weeks of study therapy with either 141W94
monotherapy or 141W94 plus zidovudine (ZDV) and lamivudine (3TC). To determine the safety and
tolerability of 141W94 monotherapy and the combination of 141W94 plus 3TC in patients with
HIV infection.
Although dramatic inhibition of HIV-1 replication is achieved with ritonavir or indinavir
monotherapy, in both cases maximum suppression required combination treatment together with
nucleoside analog RT inhibitors. This study tests the hypothesis that monotherapy with 141W94
doses that result in Cmin levels far in excess of the IC90 corrected for plasma protein
binding for HIV-1 can achieve the same virologic and immunologic effects in terms of
magnitude and durability, as has been observed with combinations of other protease inhibitors
plus nucleoside analogs.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)