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NCT00001133 · ClinicalTrials.gov registry record · Phase 1
Safety and Tolerance of Indinavir Plus Ritonavir in HIV-Positive Patients Failing Therapy With Amprenavir, Nelfinavir, or Saquinavir
A Phase 1 study of HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 50
- Enrollment target
- 7
- Study locations
NCT00001133: Completed Phase 1 study of HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00001133 is a Phase 1 study of HIV Infections that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 50 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (89% lower). The trial reports 7 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00001133, a Phase 1 study of HIV Infections, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 50 participants
- Enrollment target
- 7
- Study locations
Study Summary
In this study, the protease inhibitors indinavir (IDV) and ritonavir (RTV) will be studied in patients who have high levels of virus while taking other protease inhibitors. The purpose of this study is to see how the body takes in, distributes, and gets rid of IDV and RTV. This study will also look at any side effects that IDV or RTV causes. IDV is an effective anti-HIV drug, but it can be difficult for patients to take. For IDV to work against HIV, it must be taken 3 times a day at a high dose and with a certain diet. Doctors believe IDV may be easier to take if it is given with RTV. Patients who take IDV and RTV together may be able to take IDV only twice a day and at a lower dose. This study will gather information about the safety and side effects of using IDV and RTV together.
Conditions Studied
Interventions
- DRUG Ritonavir
- DRUG Indinavir sulfate
Study Locations (7)
California
- USC CRS - Los Angeles
- Ucsf Aids Crs - San Francisco
Alabama
- Alabama Therapeutics CRS - Birmingham
Maryland
- Johns Hopkins Adult AIDS CRS - Baltimore
New York
- NY Univ. HIV/AIDS CRS - New York
Ohio
- Univ. of Cincinnati CRS - Cincinnati
Pennsylvania
- Pitt CRS - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Est. Completion | 2006-08 |
| Phase | Phase 1 |
What the finished NCT00001133 record still lists
NCT00001133 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (89% lower).
The record links to 1 condition, with HIV Infections appearing as the primary indexed condition, and to 2 interventions - of which Ritonavir is the first listed.
NCT00001133 lists 7 locations in 6 states (California, Alabama, Maryland).
Frequently Asked Questions
What is clinical trial NCT00001133 about?
NCT00001133 is a clinical study titled "Safety and Tolerance of Indinavir Plus Ritonavir in HIV-Positive Patients Failing Therapy With Amprenavir, Nelfinavir, or Saquinavir". In this study, the protease inhibitors indinavir (IDV) and ritonavir (RTV) will be studied in patients who have high levels of virus while taking other protease inhibitors. The purpose of this study is to see how the body takes in, distributes, and gets rid of IDV and RTV. This study will also look ...
What is the current status of trial NCT00001133?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 50 participants. Estimated completion is 2006-08.
What conditions does trial NCT00001133 study?
This clinical trial studies the following conditions: HIV Infections.
What interventions are being tested in trial NCT00001133?
The interventions under investigation include: Ritonavir (DRUG), Indinavir sulfate (DRUG).
Who is sponsoring clinical trial NCT00001133?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00001133 being conducted?
This trial has 7 study locations across Alabama, California, Maryland, New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for HIV Infections
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00001133's enrollment target sits among peer trials
50 355th of 542 higher than 177 of 542 other HIV Infections trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV Infections 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.
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