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NCT00006152 · ClinicalTrials.gov registry record · Phase 2

A Study to See If Taking One or Two Extra Drugs Can Lower HIV Levels in Patients Who Have Failed Their Anti-HIV Drug Treatment

A Phase 2 study of HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Completed
Registry status
Phase 2
Development phase
42
Enrollment target
13
Study locations

NCT00006152 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 42 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (91% lower). The trial reports 13 study locations across 10 states.

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The verdict

NCT00006152, 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
42 participants
Enrollment target
13
Study locations

Study Summary

The purpose of this study is to see if adding 1 or 2 drugs to the anti-HIV therapy of patients whose HIV levels increased while taking their anti-HIV drugs can lower viral load (amount of HIV in the blood) and keep it low up to Week 24. (This study has been changed. Previously, only patients whose levels increased on their first round of anti-HIV drugs were being studied.) Anti-HIV drug treatments that contain a combination of 3 or more drugs can lower HIV levels, raise CD4 cell counts, and improve survival. Unfortunately, many patients "fail" their anti-HIV drug treatment when their HIV levels go above 500 copies/ml. Usually the next step is to switch the patient to different anti-HIV drugs. Doctors would like to see whether adding 1 or 2 different drugs to the "failed" treatment also can lower HIV levels. Adding 1 or 2 drugs might be better than switching all of the drugs since patients who take many different drugs can develop drug-resistant HIV. (This study has been changed. Previously, only patients taking protease inhibitors (PI) whose levels increased on their first round of anti-HIV drugs were being studied.)

Conditions Studied

Interventions

  • DRUG Ritonavir
  • DRUG Abacavir sulfate
  • DRUG Amprenavir

Study Locations (13)

California

  • Univ of Southern California / LA County USC Med Ctr - Los Angeles
  • Univ of California, San Diego - San Diego

Illinois

  • Northwestern Univ Med School - Chicago
  • The CORE Ctr - Chicago

North Carolina

  • Univ of North Carolina - Chapel Hill
  • Duke Univ Med Ctr - Durham

Alabama

  • Univ of Alabama at Birmingham - Birmingham

Colorado

  • Univ of Colorado Health Sciences Ctr - Denver

Massachusetts

  • Beth Israel Deaconess - West Campus - Boston

Missouri

  • St Louis Regional Hosp / St Louis Regional Med Ctr - St Louis

New York

  • Beth Israel Med Ctr - New York

Trial Details

FieldValue
Enrollment Target 42 participants
Est. Completion 2002-08
Phase Phase 2

What the Registry Record Tells You About NCT00006152

The ClinicalTrials.gov registry entry for NCT00006152 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 42 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 (91% 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 3 interventions - of which Ritonavir is the first listed.

NCT00006152 reports 13 study locations spanning 10 distinct geographic areas - top geographies include California, Illinois, North Carolina.

Frequently Asked Questions

What is clinical trial NCT00006152 about?

NCT00006152 is a clinical study titled "A Study to See If Taking One or Two Extra Drugs Can Lower HIV Levels in Patients Who Have Failed Their Anti-HIV Drug Treatment". The purpose of this study is to see if adding 1 or 2 drugs to the anti-HIV therapy of patients whose HIV levels increased while taking their anti-HIV drugs can lower viral load (amount of HIV in the blood) and keep it low up to Week 24. (This study has been changed. Previously, only patients whose l...

What is the current status of trial NCT00006152?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 42 participants. Estimated completion is 2002-08.

What conditions does trial NCT00006152 study?

This clinical trial studies the following conditions: HIV Infections.

What interventions are being tested in trial NCT00006152?

The interventions under investigation include: Ritonavir (DRUG), Abacavir sulfate (DRUG), Amprenavir (DRUG).

Who is sponsoring clinical trial NCT00006152?

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 NCT00006152 being conducted?

This trial has 13 study locations across Alabama, California, Colorado, 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

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