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Completed Phase 2 Interventional

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

ClinicalTrials.gov ID: NCT00006152

Public ClinicalTrials.gov record NCT00006152. 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.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 3:53 AM EDT

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, Restrictively Randomized, Open-Label, Pilot Study of Treatment Intensification of Early Virologic Failure

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.)

Study identification

NCT ID
NCT00006152
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Enrollment
42 participants

Conditions and interventions

Conditions

Interventions

Drug

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
Jul 31, 2002
Last update posted
Oct 31, 2021

Ends 2002

United States locations

U.S. sites
13
U.S. states
10
U.S. cities
12
Facility City State ZIP Site status
Univ of Alabama at Birmingham Birmingham Alabama 35294
Univ of Southern California / LA County USC Med Ctr Los Angeles California 900331079
Univ of California, San Diego San Diego California 92103
Univ of Colorado Health Sciences Ctr Denver Colorado 80262
Northwestern Univ Med School Chicago Illinois 60611
The CORE Ctr Chicago Illinois 60612
Beth Israel Deaconess - West Campus Boston Massachusetts 02215
St Louis Regional Hosp / St Louis Regional Med Ctr St Louis Missouri 63112
Beth Israel Med Ctr New York New York 10003
Univ of North Carolina Chapel Hill North Carolina 275997215
Duke Univ Med Ctr Durham North Carolina 27710
Julio Arroyo West Columbia South Carolina 29169
Univ of Texas Galveston Galveston Texas 775550435

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 NCT00006152, 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 Oct 31, 2021 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00006152 live on ClinicalTrials.gov.

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