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A Clinical Study Of An Investigational Regimen Including Marketed HIV Drugs In HIV-1 Pediatric Subjects Ages 2-18 Years
NCT00040664 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00040664
The ClinicalTrials.gov registry entry for NCT00040664 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 69 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is ViiV Healthcare, which has 82 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00040664 reports 20 study locations spanning 14 distinct geographic areas — top geographies include New York, Florida, North Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00040664?
The interventions under investigation include: ritonavir (DRUG), fosamprenavir (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00040664?
This trial is sponsored by ViiV Healthcare, which has 82 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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