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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 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.

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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.

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

FieldValue
Enrollment Target 342 participants
Phase Phase 2

What the Registry Record Tells You About NCT00021463

The ClinicalTrials.gov registry entry for NCT00021463 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 342 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 445-participant average among 542 other HIV Infections trials with a reported enrollment target (23% 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 2 conditions, with HIV Infections appearing as the primary indexed condition, and to 4 interventions - of which Efavirenz is the first listed.

NCT00021463 reports 11 study locations spanning 7 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.