Four-Drug Combination Therapy With Zidovudine, Lamivudine, 1592U89 (Abacavir), and 141W94 (Amprenavir) in HIV-Infected Patients
An Open-Label, Single Center Trial to Evaluate the Efficacy and Safety of Quadruple Chemotherapy (Zidovudine, EPIVIR, 1592U89, and 141W94) in Subjects Infected With HIV-1 (GW QUAD)
3 other identifiers
interventional
25
1 country
1
Brief Summary
The purpose of this study is to see if the multidrug combination of zidovudine (ZDV), lamivudine (3TC), 1592U89 (abacavir \[ABC\]), and 141W94 (amprenavir \[APV\]) is a safe and effective treatment for HIV-infected patients and if there is a reduction of active HIV in blood and other tissues. HIV infection is a life-changing illness and new HIV treatments must be tested. This study will test if a 4-drug combination will reduce HIV virus activity in blood and other tissues and if it is safe and well tolerated. Doctors also want to know if the multidrug combination is able to decrease viral activity over a long time period.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable hiv-infections
1 active site
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
December 6, 2000
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2007
CompletedMay 15, 2015
December 1, 2004
December 6, 2000
May 14, 2015
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Patients may be eligible for this study if they:
- Are at least 18 years old.
- Have a chronic (long-term) HIV infection (greater than 90 days) or a recent HIV infection.
- Have a plasma viral load (level of HIV in the blood) of at least 5,000 copies/ml (for chronically infected patients only).
- Are able to follow study requirements.
- Agree to practice reliable forms of birth control such as barrier or surgical methods, starting 1 month prior to entry and while enrolled in the study.
You may not qualify if:
- Patients will not be eligible for this study if they:
- Have had prior anti-HIV treatment (for recently infected patients only).
- Have a history of blood-clotting problems.
- Have ever received treatment with protease inhibitors or 3TC.
- Are at high risk for developing an infection in the heart.
- Are critically ill.
- Are mentally disabled, a prisoner, or confined in an institution.
- Are breast-feeding or pregnant.
- Have gastrointestinal problems that might interfere with drug absorption or are unable to take medicines by mouth.
- Need regular blood transfusions.
- Have had an unexplained fever higher than 38.5 C for more than 14 days within 30 days of enrollment.
- Have an opportunistic (AIDS-related) infection that requires treatment (treatment must be completed 30 days before the start of the study).
- Are taking certain medications that may interfere with the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Aaron Diamond AIDS Res Ctr
New York, New York, 10016, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Martin Markowitz
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Masking
- NONE
- Purpose
- TREATMENT
- Sponsor Type
- NIH
Study Record Dates
First Submitted
December 6, 2000
First Posted
August 31, 2001
Primary Completion
June 1, 2007
Study Completion
June 1, 2007
Last Updated
May 15, 2015
Record last verified: 2004-12