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 II, Restrictively Randomized, Open-Label, Pilot Study of Treatment Intensification of Early Virologic Failure
4 other identifiers
interventional
42
1 country
13
Brief 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.)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 hiv-infections
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 7, 2000
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2002
CompletedNovember 1, 2021
October 1, 2021
August 7, 2000
October 28, 2021
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Patients may be eligible for this study if they:
- Are HIV-positive.
- Are taking 3 or more anti-HIV drugs for at least 24 weeks. (This study has been changed. Previously, only patients taking their first round of anti-HIV drugs, which included a PI, were being studied.)
- Had a viral load below 500 copies/ml while on their anti-HIV drugs, and then had an increase in viral load to between 500 and 10,000 copies/ml. (This study has been changed. Previously, only patients whose levels increased on their first round of anti-HIV drugs were being studied.)
- Have a CD4 cell count of 100 cells/mm3 or more.
- Are age 13 or older (consent of a parent or legal guardian is required if under 18).
- Agree to use 2 methods of birth control during the study and for 60 days after. (This study has changed the birth control requirements.)
You may not qualify if:
- Patients will not be eligible for this study if they:
- Are currently being treated for a serious infection or other serious medical illness.
- Have had certain illnesses in the past.
- Have a fever within 7 days of study entry.
- Have already taken all of the study drugs for more than 4 weeks.
- Are unable to take any of the study drugs.
- Have certain types of cancer.
- Received certain vaccines within 21 days of study entry.
- Have received certain medications.
- Are pregnant or breast-feeding.
- Patients will not be eligible for Group A if they:
- Have a history of hypersensitivity reaction to abacavir.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, 900331079, United States
Univ of California, San Diego
San Diego, California, 92103, United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262, United States
Northwestern Univ Med School
Chicago, Illinois, 60611, United States
The CORE Ctr
Chicago, Illinois, 60612, United States
Beth Israel Deaconess - West Campus
Boston, Massachusetts, 02215, United States
St Louis Regional Hosp / St Louis Regional Med Ctr
St Louis, Missouri, 63112, United States
Beth Israel Med Ctr
New York, New York, 10003, United States
Univ of North Carolina
Chapel Hill, North Carolina, 275997215, United States
Duke Univ Med Ctr
Durham, North Carolina, 27710, United States
Julio Arroyo
West Columbia, South Carolina, 29169, United States
Univ of Texas Galveston
Galveston, Texas, 775550435, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Robert Murphy
- STUDY CHAIR
William Powderly
- STUDY CHAIR
Mary Albrecht
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Purpose
- TREATMENT
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 7, 2000
First Posted
August 31, 2001
Study Completion
August 1, 2002
Last Updated
November 1, 2021
Record last verified: 2021-10