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NCT00000861 · ClinicalTrials.gov registry record · NA
The Addition of Indinavir to Anti-HIV Treatment in HIV-Infected Patients
A NA study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- NA
- Development phase
- 1,900
- Enrollment target
NCT00000861: Completed NA study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00000861 is a NA study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 1,900 participants, above the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (35% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00000861, a NA study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- NA
- Development phase
- 1,900 participants
- Enrollment target
Study 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.
Interventions
- DRUG Indinavir sulfate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,900 participants |
| Est. Completion | 1997-03 |
| Phase | NA |
What the finished NCT00000861 record still lists
NCT00000861 is an interventional study that assigns participants to a tested intervention. Its 1,900 participants enrollment target places it among the larger protocols in the corpus, above the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (35% higher).
The record links to 0 conditions, and to 1 intervention - of which Indinavir sulfate is the first listed.
NCT00000861 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00000861 about?
NCT00000861 is a clinical study titled "The Addition of Indinavir to Anti-HIV Treatment in HIV-Infected Patients". 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 exami...
What is the current status of trial NCT00000861?
This trial is currently completed. It is a NA study. The enrollment target is 1,900 participants. Estimated completion is 1997-03.
What interventions are being tested in trial NCT00000861?
The interventions under investigation include: Indinavir sulfate (DRUG).
Who is sponsoring clinical trial NCT00000861?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00000861's enrollment target sits among peer trials
1,900 55th of 2000 higher than 1,946 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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