Effects of Changing HIV Therapy at Lower Versus Higher Viral Loads
Public ClinicalTrials.gov record NCT00036465. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase II, Randomized, Controlled, Pilot Study of Antiretroviral Switch at Lower Versus Higher HIV-1 RNA Levels in Subjects Experiencing Virologic Relapse on a Current HAART Regimen
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT00036465
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 60 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 13 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Not listed
- Primary completion
- Not listed
- Completion
- Aug 31, 2005
- Last update posted
- Jul 28, 2013
Ends 2005
United States locations
- U.S. sites
- 23
- U.S. states
- 14
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Willow Clinic | Menlo Park | California | 94025 | — |
| San Mateo AIDS Program / Stanford Univ | Stanford | California | 94305-5107 | — |
| Stanford Univ Med Ctr | Stanford | California | 94305-5107 | — |
| Harbor General/UCLA | Torrance | California | 90502-2052 | — |
| Univ of Colorado Health Sciences Ctr | Denver | Colorado | 80262 | — |
| Univ of Miami School of Medicine | Miami | Florida | 331361013 | — |
| Univ of Hawaii | Honolulu | Hawaii | 96816 | — |
| Northwestern Univ | Chicago | Illinois | 60611 | — |
| Rush Presbyterian - Saint Luke's Med Ctr | Chicago | Illinois | 60612 | — |
| The CORE Ctr | Chicago | Illinois | 60612 | — |
| Harvard (Masschusetts General Hosp) | Boston | Massachusetts | 02114 | — |
| Brigham and Womens Hosp | Boston | Massachusetts | 02215 | — |
| Bellevue Hosp / New York Univ Med Ctr | New York | New York | 10016 | — |
| Univ of North Carolina | Chapel Hill | North Carolina | 27599-7215 | — |
| Duke Univ Med Ctr | Durham | North Carolina | 27710 | — |
| Univ of Cincinnati | Cincinnati | Ohio | 452670405 | — |
| Univ of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | — |
| Brown Univ / Miriam Hosp | Providence | Rhode Island | 02906 | — |
| Miriam Hosp / Brown Univ | Providence | Rhode Island | 02906 | — |
| Comprehensive Care Clinic / Vanderbilt Univ Med Ctr | Nashville | Tennessee | 37203 | — |
| Univ of Texas, Southwestern Med Ctr of Dallas | Dallas | Texas | 75390 | — |
| Univ of Texas Galveston | Galveston | Texas | 775550435 | — |
| Univ of Washington | Seattle | Washington | 98104 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00036465, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 28, 2013 · Synced Sep 24, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00036465 live on ClinicalTrials.gov.