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NCT00012519 · ClinicalTrials.gov registry record · Phase 1
Ritonavir and Indinavir in Children Failing Other Anti-HIV Treatment
A Phase 1 study of HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 29
- Enrollment target
- 12
- Study locations
NCT00012519: Completed Phase 1 study of HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00012519 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 29 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (93% lower). The trial reports 12 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00012519, 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
- 29 participants
- Enrollment target
- 12
- Study locations
Study Summary
Both ritonavir (RTV) and indinavir (IDV) are approved by the FDA to treat HIV, but IDV has not been approved for use in children and the doses for the combination of the two drugs has not been studied in children. The purpose of this study is to find a combination of RTV and IDV that is safe, well tolerated, and produces drug levels in the blood of children that are comparable to effective drug levels in the blood of adults. The effectiveness of the drug combination in decreasing the amount of virus in the body will also be studied. The children enrolled in this study will have high HIV viral loads despite taking anti-HIV drugs.
Conditions Studied
Interventions
- DRUG ritonavir
- DRUG indinavir sulfate
Study Locations (12)
New York
- Metropolitan Hosp. Ctr. - New York
- Columbia IMPAACT CRS - New York
- Harlem Hosp. Ctr. NY NICHD CRS - New York
- SUNY Upstate Med. Univ., Dept. of Peds. - Syracuse
Florida
- Univ. of Florida College of Medicine-Dept of Peds, Div. of Immunology, Infectious Diseases & Allergy - Gainesville
- Univ. of Florida Jacksonville NICHD CRS - Jacksonville
District of Columbia
- Howard Univ. Washington DC NICHD CRS - Washington D.C.
Illinois
- Chicago Children's CRS - Chicago
Tennessee
- St. Jude/UTHSC CRS - Memphis
Texas
- Texas Children's Hosp. CRS - Houston
Virginia
- VCU Health Systems, Dept. of Peds - Richmond
Other
- San Juan City Hosp. PR NICHD CRS - San Juan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Est. Completion | 2005-07 |
| Phase | Phase 1 |
What the finished NCT00012519 record still lists
NCT00012519 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (93% 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.
NCT00012519 lists 12 locations in 8 states (New York, Florida, District of Columbia).
Frequently Asked Questions
What is clinical trial NCT00012519 about?
NCT00012519 is a clinical study titled "Ritonavir and Indinavir in Children Failing Other Anti-HIV Treatment". Both ritonavir (RTV) and indinavir (IDV) are approved by the FDA to treat HIV, but IDV has not been approved for use in children and the doses for the combination of the two drugs has not been studied in children. The purpose of this study is to find a combination of RTV and IDV that is safe, well t...
What is the current status of trial NCT00012519?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 29 participants. Estimated completion is 2005-07.
What conditions does trial NCT00012519 study?
This clinical trial studies the following conditions: HIV Infections.
What interventions are being tested in trial NCT00012519?
The interventions under investigation include: ritonavir (DRUG), indinavir sulfate (DRUG).
Who is sponsoring clinical trial NCT00012519?
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 NCT00012519 being conducted?
This trial has 12 study locations across District of Columbia, Florida, Illinois, New York, Tennessee. 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 NCT00012519's enrollment target sits among peer trials
29 442nd of 542 higher than 97 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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