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NCT00260078 · ClinicalTrials.gov registry record · Phase 1
Blood Levels of Anti-HIV Drugs Used in Combination Regimens in HIV Infected Children
A Phase 1 study of HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 75
- Enrollment target
- 20
- Study locations
NCT00260078: Completed Phase 1 study of HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00260078 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 75 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (83% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00260078, 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
- 75 participants
- Enrollment target
- 20
- Study locations
Study Summary
Limited data exist about combination anti-HIV treatment regimens in children, including how those drugs are cleared by the body in children. The purpose of this study is to measure the blood levels of the following combinations of anti-HIV drugs in HIV infected chilren: tenofovir disoproxil fumurate (TDF) and efavirenz (EFV) or nevirapine (NVP); TDF and darunavir (DRV) with or without EFV; and TDF and ritonavir (RTV) with or without EFV.
Conditions Studied
Interventions
- DRUG Ritonavir
- DRUG Atazanavir
- DRUG Efavirenz
- DRUG Nevirapine
- DRUG Darunavir
Study Locations (20)
California
- Usc La Nichd Crs - Alhambra
- University of California, UC San Diego CRS - La Jolla
- Miller Children's Hosp. Long Beach CA NICHD CRS - Long Beach
- Harbor UCLA Medical Ctr. NICHD CRS - Torrance
Massachusetts
- Children's Hosp. of Boston NICHD CRS - Boston
- Baystate Health, Baystate Med. Ctr. - Springfield
- WNE Maternal Pediatric Adolescent AIDS CRS - Worcester
New York
- SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS - Brooklyn
- Nyu Ny Nichd Crs - New York
- Jacobi Med. Ctr. Bronx NICHD CRS - The Bronx
Illinois
- Rush Univ. Cook County Hosp. Chicago NICHD CRS - Chicago
- Ann & Robert H. Lurie Children's Hospital of Chicago (LCH) CRS - Chicago
Maryland
- Univ. of Maryland Baltimore NICHD CRS - Baltimore
- Johns Hopkins Univ. Baltimore NICHD CRS - Baltimore
Connecticut
- Connecticut Children's Med. Ctr. - Hartford
Florida
- Pediatric Perinatal HIV Clinical Trials Unit CRS - Miami
Michigan
- Children's Hospital of Michigan NICHD CRS - Detroit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2006-02 |
| Est. Completion | 2009-04 |
| Phase | Phase 1 |
What the finished NCT00260078 record still lists
NCT00260078 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (83% lower).
The record links to 1 condition, with HIV Infections appearing as the primary indexed condition, and to 5 interventions - of which Ritonavir is the first listed.
NCT00260078 names 20 study sites across 11 states, led by California, Massachusetts, New York.
Frequently Asked Questions
What is clinical trial NCT00260078 about?
NCT00260078 is a clinical study titled "Blood Levels of Anti-HIV Drugs Used in Combination Regimens in HIV Infected Children". Limited data exist about combination anti-HIV treatment regimens in children, including how those drugs are cleared by the body in children. The purpose of this study is to measure the blood levels of the following combinations of anti-HIV drugs in HIV infected chilren: tenofovir disoproxil fumurate...
What is the current status of trial NCT00260078?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 75 participants. The study started on 2006-02. Estimated completion is 2009-04.
What conditions does trial NCT00260078 study?
This clinical trial studies the following conditions: HIV Infections.
What interventions are being tested in trial NCT00260078?
The interventions under investigation include: Ritonavir (DRUG), Atazanavir (DRUG), Efavirenz (DRUG), Nevirapine (DRUG), Darunavir (DRUG).
Who is sponsoring clinical trial NCT00260078?
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 NCT00260078 being conducted?
This trial has 20 study locations across California, Connecticut, Florida, Illinois, Maryland. 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 NCT00260078's enrollment target sits among peer trials
75 306th of 542 higher than 235 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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