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NCT00040664 · ClinicalTrials.gov registry record · Phase 2
A Clinical Study Of An Investigational Regimen Including Marketed HIV Drugs In HIV-1 Pediatric Subjects Ages 2-18 Years
A Phase 2 study of HIV Infection, sponsored by ViiV Healthcare.
- Completed
- Registry status
- Phase 2
- Development phase
- 69
- Enrollment target
- 20
- Study locations
NCT00040664: Completed Phase 2 study of HIV Infection, sponsored by ViiV Healthcare.
NCT00040664 is a Phase 2 study of HIV Infection that has completed, run by ViiV Healthcare. The registered enrollment target is 69 participants, below the 242-participant average among 73 other HIV Infection trials with a reported enrollment target (71% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00040664, a Phase 2 study of HIV Infection, has completed, sponsored by ViiV Healthcare.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 69 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a 48-week study to collect additional information on the safety, tolerability, pharmacokinetics, and antiviral activity of an investigational regimen (course of therapy) including FDA approved HIV drugs in HIV-infected patients 2 - 18 years old.
Primary Outcome
The number of participants who prematurely discontinued study drug due to adverse events was tabulated. Data are summarized by individual adverse event.
Conditions Studied
Interventions
- DRUG ritonavir
- DRUG fosamprenavir
Study Locations (20)
New York
- GSK Investigational Site - New York
- GSK Investigational Site - New York
- GSK Investigational Site - Stony Brook
- GSK Investigational Site - The Bronx
Florida
- GSK Investigational Site - Jacksonville
- GSK Investigational Site - Tampa
North Carolina
- GSK Investigational Site - Chapel Hill
- GSK Investigational Site - Durham
Texas
- GSK Investigational Site - Dallas
- GSK Investigational Site - Fort Worth
Alabama
- GSK Investigational Site - Birmingham
California
- GSK Investigational Site - Los Angeles
Illinois
- GSK Investigational Site - Chicago
Louisiana
- GSK Investigational Site - New Orleans
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 69 participants |
| Start Date | 2002-07 |
| Est. Completion | 2008-10 |
| Phase | Phase 2 |
What the finished NCT00040664 record still lists
NCT00040664 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 69 participants, a relatively small participant target, below the 242-participant average among 73 other HIV Infection trials with a reported enrollment target (71% lower).
The record links to 1 condition, with HIV Infection appearing as the primary indexed condition, and to 2 interventions - of which ritonavir is the first listed.
NCT00040664 names 20 study sites across 14 states, led by New York, Florida, North Carolina.
Frequently Asked Questions
What is clinical trial NCT00040664 about?
NCT00040664 is a clinical study titled "A Clinical Study Of An Investigational Regimen Including Marketed HIV Drugs In HIV-1 Pediatric Subjects Ages 2-18 Years". This is a 48-week study to collect additional information on the safety, tolerability, pharmacokinetics, and antiviral activity of an investigational regimen (course of therapy) including FDA approved HIV drugs in HIV-infected patients 2 - 18 years old.
What is the current status of trial NCT00040664?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 69 participants. The study started on 2002-07. Estimated completion is 2008-10.
What conditions does trial NCT00040664 study?
This clinical trial studies the following conditions: HIV Infection.
What interventions are being tested in trial NCT00040664?
The interventions under investigation include: ritonavir (DRUG), fosamprenavir (DRUG).
Who is sponsoring clinical trial NCT00040664?
This trial is sponsored by ViiV Healthcare, which has 182 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00040664 being conducted?
This trial has 20 study locations across Alabama, California, Florida, Illinois, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for HIV Infection
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 NCT00040664's enrollment target sits among peer trials
69 32nd of 73 higher than 42 of 73 other HIV Infection trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV Infection 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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