The Addition of Indinavir to Anti-HIV Treatment in HIV-Infected Patients
Status:
Completed
Trial end date:
1997-03-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is to evaluate the effect of immediate versus deferred indinavir
(IDV) in addition to background therapy on disease progression or death in patients with CD4+
cell counts between 200 and 500 cells/mm3 and plasma HIV RNA levels >= 10,000 copies/ml.
This study aims to examine two management strategies, immediate versus deferred IDV therapy,
for their clinical effects in the context of background antiretroviral (AR) therapy, given
according to current clinical practice. There is an urgent need to identify the optimal use
of IDV in patient management, since clinical endpoint studies have not been completed in the
United States. Since there is little information about the long term durability of clinical
effects, and even less information about the timing of the initiation of protease inhibitor
therapy, exploring the disease progression and survival impact of immediate versus delayed
use of IDV will yield important information to guide clinical decision making for this group
of patients.
Phase:
N/A
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)