A Study of Three Anti-HIV Drug Combinations in Patients Who Have Taken Amprenavir
Status:
Completed
Trial end date:
1999-10-01
Target enrollment:
Participant gender:
Summary
To determine the proportion of patients treated with amprenavir, zidovudine (ZDV), stavudine
(D4T) and lamivudine (3TC) whose HIV-1 RNA level remains below the level of detection during
96 weeks of therapy. To determine the proportion of patients treated with indinavir (IDV),
nevirapine (NVP), 3TC, and d4T whose HIV-1 RNA level decreases and then remains below the
level of detection, during the 96-week therapy period. To determine the viral effects,
safety, tolerability, and pharmacokinetics of amprenavir in combination with zidovudine,
stavudine, and lamivudine. [AS PER AMENDMENT 2/27/98: To determine the proportion of patients
with undetectable plasma HIV RNA, by treatment and baseline RNA cohort (either detectable or
undetectable). To determine the durability of these regimens by estimating the distribution
of time to loss of virologic suppression (or equivalently, time to virologic failure), by
treatment and baseline RNA cohort.] This study allows patients who have successfully
participated in ACTG 347 or other trials involving amprenavir to continue treatment with
amprenavir, ZDV, d4T, and 3TC. Additionally, this study provides patients whose HIV-1 RNA was
not reduced to undetectable levels or who had a significant increase in plasma levels
("treatment failures") the opportunity to change to a potentially more active regimen that
includes indinavir, nevirapine, lamivudine, and stavudine.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)