Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 2 study of HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
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. According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00036465 record still lists
NCT00036465 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (87% lower).
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 names 20 study sites across 12 states, led by 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.
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 NCT00036465's enrollment target sits among peer trials
60 322nd of 542 higher than 205 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.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Phase 2b Study Evaluating Oral VH4524184 Regimens in Treatment Naïve Persons With HIV-1 (INNOVATE Study)
RECRUITING · Phase 2
-
Microbiome Metabolites and Alcohol in HIV to Reduce CVD RCT
RECRUITING · Phase 2
-
Cholesterol and Inflammation Lowering Via Bempedoic Acid, an ACL-inhibiting Regimen in HIV Trial (CLEAR HIV Trial)
RECRUITING · Phase 2
-
Imaging Immune Activation in HIV by PET-MR
RECRUITING · Phase 2
-
A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of a New Formulation of Cabotegravir Long-Acting Administered Intramuscularly in a 4-month Dosing Interval (Q4M)
ACTIVE NOT RECRUITING · Phase 2
-
A Study to Investigate the Virologic Efficacy and Safety of VH3810109 + Cabotegravir Compared to Standard of Care (SOC) in Male and Female Adults Living With Human Immunodeficiency Virus (HIV)
ACTIVE NOT RECRUITING · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00576069 · 60 participants
Mechanism(s)of Airflow Limitation in Moderate-severe Persistent Asthma
- NCT01297400 · 60 participants · Phase 2
Phase 2 Pilot Study of the Safety and Efficacy of Topical MW-III in Thermal Burns
- NCT01734122 · 60 participants
Stereotactic Radiosurgery for Essential Tremor and Parkinsonian Tremor
- NCT01804634 · 60 participants · Phase 2
Reduced Intensity Haploidentical BMT for High Risk Solid Tumors