Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00021463 · ClinicalTrials.gov registry record · Phase 2
Changing to Nonprotease Inhibitor Treatment to Improve Side Effects
A Phase 2 study of HIV Infections and Lipodystrophy, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 342
- Enrollment target
- 11
- Study locations
NCT00021463: Completed Phase 2 study of HIV Infections and Lipodystrophy, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00021463 is a Phase 2 study of HIV Infections and Lipodystrophy that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 342 participants, below the 445-participant average among 542 other HIV Infections trials with a reported enrollment target (23% lower). The trial reports 11 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00021463, a Phase 2 study of HIV Infections and Lipodystrophy, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 342 participants
- Enrollment target
- 11
- Study locations
Study Summary
The purpose of this study is to learn whether changing from a type of anti-HIV drug called a protease inhibitor (PI) to another type of anti-HIV drug will help to lower the amount of fats or sugars in the blood. PIs have been effective at keeping HIV viral load (amount of HIV in the blood) down. However, some people who take PIs have higher than normal levels of fats and/or sugars in the blood. Doctors believe that switching to anti-HIV drugs that do not contain PIs will improve the abnormal side effects. This study will test 3 different combinations of non-PI drugs to see which may improve side effects while keeping viral loads low.
Conditions Studied
Interventions
- DRUG Efavirenz
- DRUG Nevirapine
- DRUG Abacavir sulfate
- DRUG Abacavir sulfate, Lamivudine and Zidovudine
Study Locations (11)
Illinois
- Northwestern Univ Med School - Chicago
- The CORE Ctr - Chicago
Massachusetts
- Boston Med Ctr - Boston
- Brigham and Women's Hosp - Boston
New York
- Beth Israel Med Ctr - New York
- Bellevue Hosp / New York Univ Med Ctr - New York
Pennsylvania
- Univ of Pennsylvania - Philadelphia
- Univ of Pittsburgh - Pittsburgh
Alabama
- Univ of Alabama at Birmingham - Birmingham
District of Columbia
- Georgetown Univ Med Ctr - Washington D.C.
Georgia
- Emory Univ - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 342 participants |
| Phase | Phase 2 |
What the finished NCT00021463 record still lists
NCT00021463 is an interventional study that assigns participants to a tested intervention. The registered 342 participants enrollment target is mid-sized for trials with a published cap, below the 445-participant average among 542 other HIV Infections trials with a reported enrollment target (23% lower).
The record links to 2 conditions, with HIV Infections appearing as the primary indexed condition, and to 4 interventions - of which Efavirenz is the first listed.
NCT00021463 lists 11 locations in 7 states (Illinois, Massachusetts, New York).
Frequently Asked Questions
What is clinical trial NCT00021463 about?
NCT00021463 is a clinical study titled "Changing to Nonprotease Inhibitor Treatment to Improve Side Effects". The purpose of this study is to learn whether changing from a type of anti-HIV drug called a protease inhibitor (PI) to another type of anti-HIV drug will help to lower the amount of fats or sugars in the blood. PIs have been effective at keeping HIV viral load (amount of HIV in the blood) down. Ho...
What is the current status of trial NCT00021463?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 342 participants.
What conditions does trial NCT00021463 study?
This clinical trial studies the following conditions: HIV Infections, Lipodystrophy.
What interventions are being tested in trial NCT00021463?
The interventions under investigation include: Efavirenz (DRUG), Nevirapine (DRUG), Abacavir sulfate (DRUG), Abacavir sulfate, Lamivudine and Zidovudine (DRUG).
Who is sponsoring clinical trial NCT00021463?
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 NCT00021463 being conducted?
This trial has 11 study locations across Alabama, District of Columbia, Georgia, Illinois, Massachusetts. 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 NCT00021463's enrollment target sits among peer trials
342 102nd of 542 higher than 441 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
- NCT05283850 · 342 participants · Phase 2
Surviving PEA in Roanoke (SPEAR) Study
- NCT05714085 · 342 participants · Phase 2
Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036)
- NCT06188702 · 342 participants · Phase 1
S095035 as a Single Agent and in Combination in Adult Participants With Advanced or Metastatic Solid Tumors With Deletion of MTAP
- NCT06544941 · 342 participants · NA
Improving Maternal Sleep and Mental Health