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NCT00036465 · ClinicalTrials.gov registry record · Phase 2
Effects of Changing HIV Therapy at Lower Versus Higher Viral Loads
A Phase 2 study of HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
- 20
- Study locations
NCT00036465 is a Phase 2 study of HIV Infections that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 60 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (87% lower). The trial reports 20 study locations across 12 states.
The verdict
NCT00036465, a Phase 2 study of HIV Infections, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study will look at people who have been taking anti-HIV drugs but still have detectable levels of HIV. The purpose of the study is to find out what happens in those people who change anti-HIV drugs when their viral load reaches 200 copies compared to those who change anti-HIV drugs when their viral load reaches 10,000 copies. This study will also look at drug resistance (how well HIV responds to drugs), viral fitness (how well drug-resistant HIV copies itself), and immunologic reconstitution (how well the immune system recognizes various infections, including HIV). Many patients experience virologic relapse (increase in viral load after sustained viral load suppression) within 1 to 2 years of taking anti-HIV drugs. The approach to treatment for patients who experience virologic relapse while on a highly active antiretroviral therapy (HAART) has not been defined. Current guidelines recommend switching to a new treatment regimen as soon as possible to prevent HIV from becoming even more resistant to anti-HIV drugs. However, there is evidence that patients can benefit from staying on the same HAART drugs, even after virologic relapse. This study wants to find what happens when drugs are changed immediately after virologic relapse (when the viral load is lower) compared to what happens if drugs are changed only after a delay (when the viral load is higher).
Conditions Studied
Interventions
- BEHAVIORAL Treatment regimen change
Study Locations (20)
California
- Willow Clinic - Menlo Park
- San Mateo AIDS Program / Stanford Univ - Stanford
- Stanford Univ Med Ctr - Stanford
- Harbor General/UCLA - Torrance
Illinois
- Northwestern Univ - Chicago
- Rush Presbyterian - Saint Luke's Med Ctr - Chicago
- The CORE Ctr - Chicago
Massachusetts
- Harvard (Masschusetts General Hosp) - Boston
- Brigham and Womens Hosp - Boston
North Carolina
- Univ of North Carolina - Chapel Hill
- Duke Univ Med Ctr - Durham
Rhode Island
- Brown Univ / Miriam Hosp - Providence
- Miriam Hosp / Brown Univ - Providence
Colorado
- Univ of Colorado Health Sciences Ctr - Denver
Florida
- Univ of Miami School of Medicine - Miami
Hawaii
- Univ of Hawaii - Honolulu
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Est. Completion | 2005-09 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00036465
The ClinicalTrials.gov registry entry for NCT00036465 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (87% lower). The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with HIV Infections appearing as the primary indexed condition, and to 1 intervention - of which Treatment regimen change is the first listed.
NCT00036465 reports 20 study locations spanning 12 distinct geographic areas - top geographies include California, Illinois, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT00036465 about?
NCT00036465 is a clinical study titled "Effects of Changing HIV Therapy at Lower Versus Higher Viral Loads". This study will look at people who have been taking anti-HIV drugs but still have detectable levels of HIV. The purpose of the study is to find out what happens in those people who change anti-HIV drugs when their viral load reaches 200 copies compared to those who change anti-HIV drugs when their v...
What is the current status of trial NCT00036465?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 60 participants. Estimated completion is 2005-09.
What conditions does trial NCT00036465 study?
This clinical trial studies the following conditions: HIV Infections.
What interventions are being tested in trial NCT00036465?
The interventions under investigation include: Treatment regimen change (BEHAVIORAL).
Who is sponsoring clinical trial NCT00036465?
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 NCT00036465 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Hawaii, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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