Effectiveness of the Early Addition of Abacavir to an Anti-HIV Drug Combination
NCT ID: NCT00001132
Last Updated: 2008-09-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
80 participants
INTERVENTIONAL
1999-11-30
2001-04-30
Brief Summary
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Many patients who take 3 anti-HIV drugs together are able to achieve very low viral loads, for example, viral loads below 50 copies/ml. However, some patients taking only 3 drugs are not able to achieve a viral load this low. Doctors hope that, by adding the drug ABC to a current treatment, a viral load below 50 copies/ml can be achieved. Doctors would like to find out if it is effective to start patients on 3 drugs and then add another drug (treatment intensification) if the treatment is not working as well as hoped.
Detailed Description
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Patients entering this study will have initiated potent antiretroviral therapy. Between 60 and 90 days \[AS PER AMENDMENT 1/9/01: 60 and 104 days\] after beginning their background regimen, patients are randomized to add either ABC (Arm A) or a matching placebo (Arm B) for 12 weeks. Patients completing 12 weeks of treatment continue on study for an additional 24 weeks to Week 36. Patients discontinue treatment if virologic failure occurs at any time. Patients still return to the clinic for HIV-1 RNA measurements at Weeks 12 and 36, depending on when discontinuation occurred. Patients who discontinue treatment at or after Week 12 due to virologic failure are offered open-label ABC for the remainder of the study (through Week 36). Blood samples are collected at Weeks 4, 8, 12, 20, 28, and 36. Plasma samples for population sequencing of HIV-1 PR and RT genes are collected on all patients at study entry and at the time of virologic failure. Baseline genotype (presence or absence of PR and RT resistance mutations and number of resistance mutations) is correlated to treatment outcome. Samples from the time of failure are analyzed for the accumulation of additional resistance mutations. \[AS PER AMENDMENT 5/5/00: Patients and their primary care physicians will be unblinded to the patient's treatment after the study is completed at Week 36 or if virologic failure occurs at or after Week 12 \[AS PER AMENDMENT 1/9/01: or if ABC hypersensitivity is suspected\].\]
Conditions
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Keywords
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Study Design
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TREATMENT
DOUBLE
Interventions
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Abacavir sulfate
Eligibility Criteria
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Inclusion Criteria
* Are HIV-positive.
* Have been taking anti-HIV therapy that includes at least 3 anti-HIV drugs and is an acceptable anti-HIV drug combination for 60 to 104 days before study treatment. Patients must not have changed any of the drugs in the 28 days before study entry. (This study has been changed by extending the number of days that anti-HIV therapy has been received.)
* Have a viral load greater than 500 but less than or equal to 10,000 copies/ml and have had a significant decrease in viral load between 49 and 84 days after starting this anti-HIV therapy. (This study has been changed by extending the length of time of viral load decrease.)
* Are at least 13 years old (consent of parent or guardian required if under 18).
* Agree to practice abstinence or use barrier method of birth control (such as condoms) during the study and for 3 months after.
Exclusion Criteria
* Have ever taken ABC.
* Have received anti-HIV therapy for more than 104 days in the past. (This study has been changed by extending the number of days that anti-HIV therapy has been received.)
* Have a fever for 7 days in the 30 days before study entry.
* Have cancer, including Kaposi's sarcoma, that requires chemotherapy.
* Have an active infection that requires treatment in the 21 days before study entry.
* Have any opportunistic (AIDS-related) infection or disease that requires a change in medication in the 14 days before study entry.
* Have any medical condition or history of an illness that the doctor feels would place them at risk or make them unable to complete the study.
* Are taking drugs that affect the immune system or any experimental anti-HIV drugs, except for their current drug combination.
* Are taking St. John's wort. (This study has been changed. Previously, patients taking St. John's wort were eligible.)
* Have received a vaccine in the 21 days before study entry.
* Are pregnant or breast-feeding.
13 Years
ALL
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Principal Investigators
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John Bartlett
Role: STUDY_CHAIR
Pablo Tebas
Role: STUDY_CHAIR
Locations
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UCLA CARE Ctr
Los Angeles, California, United States
Willow Clinic
Menlo Park, California, United States
Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium
San Jose, California, United States
San Mateo AIDS Program / Stanford Univ
Stanford, California, United States
Stanford Univ Med Ctr
Stanford, California, United States
Harbor UCLA Med Ctr
Torrance, California, United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, United States
Univ of Miami School of Medicine
Miami, Florida, United States
Emory Univ
Atlanta, Georgia, United States
Northwestern Univ Med School
Chicago, Illinois, United States
Cook County Hosp
Chicago, Illinois, United States
State of MD Div of Corrections / Johns Hopkins Univ Hosp
Baltimore, Maryland, United States
Johns Hopkins Hosp
Baltimore, Maryland, United States
St Louis Regional Hosp / St Louis Regional Med Ctr
St Louis, Missouri, United States
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, United States
Beth Israel Med Ctr
New York, New York, United States
Bellevue Hosp / New York Univ Med Ctr
New York, New York, United States
Aaron Diamond AIDS Rsch Ctr / Rockefeller Univ
New York, New York, United States
Columbia Presbyterian Med Ctr
New York, New York, United States
Univ of Rochester Medical Center
Rochester, New York, United States
Univ of North Carolina
Chapel Hill, North Carolina, United States
Duke Univ Med Ctr
Durham, North Carolina, United States
Univ of Cincinnati
Cincinnati, Ohio, United States
Philadelphia Veterans Administration Med Ctr
Philadelphia, Pennsylvania, United States
Univ of Pennsylvania at Philadelphia
Philadelphia, Pennsylvania, United States
Julio Arroyo
West Columbia, South Carolina, United States
Vanderbilt Univ Med Ctr
Nashville, Tennessee, United States
Univ of Texas, Southwestern Med Ctr of Dallas
Dallas, Texas, United States
Univ of Washington
Seattle, Washington, United States
Univ of Puerto Rico
San Juan, , Puerto Rico
Countries
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References
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Bartlett JA, Tebas P, Bassett R, Huang W, Kuritzkes D, Reisler R, Loyack N, Robison K; ACTG A5064 Team. Early intensification with abacavir in subjects at high risk for incomplete viral suppression. Antivir Ther. 2003 Aug;8(4):361-3. No abstract available.
Other Identifiers
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AACTG A5064
Identifier Type: -
Identifier Source: secondary_id
ACTG A5064
Identifier Type: -
Identifier Source: org_study_id