Effectiveness of the Early Addition of Abacavir to an Anti-HIV Drug Combination
A Pilot Study of Early Treatment Intensification of Antiretroviral Therapy
2 other identifiers
interventional
80
2 countries
30
Brief Summary
The purpose of this study is to see if adding 1 drug to an anti-HIV drug combination early in treatment against HIV can lower the viral load (amount of HIV in the blood) to a level so low that it cannot be measured (undetectable). The drug that will be added to a treatment is abacavir (ABC). 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.
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
Started Nov 1999
Shorter than P25 for phase_2 hiv-infections
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 1999
CompletedFirst Submitted
Initial submission to the registry
January 17, 2000
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2001
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedSeptember 9, 2008
June 1, 2003
January 17, 2000
September 8, 2008
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Patients may be eligible for this study if they:
- 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.
You may not qualify if:
- Patients will not be eligible for this study if they:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (30)
UCLA CARE Ctr
Los Angeles, California, 90095, United States
Willow Clinic
Menlo Park, California, 94025, United States
Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium
San Jose, California, 951282699, United States
San Mateo AIDS Program / Stanford Univ
Stanford, California, 943055107, United States
Stanford Univ Med Ctr
Stanford, California, 943055107, United States
Harbor UCLA Med Ctr
Torrance, California, 90502, United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262, United States
Univ of Miami School of Medicine
Miami, Florida, 331361013, United States
Emory Univ
Atlanta, Georgia, 30308, United States
Northwestern Univ Med School
Chicago, Illinois, 60611, United States
Cook County Hosp
Chicago, Illinois, 60612, United States
State of MD Div of Corrections / Johns Hopkins Univ Hosp
Baltimore, Maryland, 212052196, United States
Johns Hopkins Hosp
Baltimore, Maryland, 21287, United States
St Louis Regional Hosp / St Louis Regional Med Ctr
St Louis, Missouri, 63112, United States
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, 14215, United States
Beth Israel Med Ctr
New York, New York, 10003, United States
Bellevue Hosp / New York Univ Med Ctr
New York, New York, 10016, United States
Aaron Diamond AIDS Rsch Ctr / Rockefeller Univ
New York, New York, 10021, United States
Columbia Presbyterian Med Ctr
New York, New York, 10032, United States
Univ of Rochester Medical Center
Rochester, New York, 14642, United States
Univ of North Carolina
Chapel Hill, North Carolina, 275997215, United States
Duke Univ Med Ctr
Durham, North Carolina, 27710, United States
Univ of Cincinnati
Cincinnati, Ohio, 452670405, United States
Philadelphia Veterans Administration Med Ctr
Philadelphia, Pennsylvania, 19104, United States
Univ of Pennsylvania at Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Julio Arroyo
West Columbia, South Carolina, 29169, United States
Vanderbilt Univ Med Ctr
Nashville, Tennessee, 37203, United States
Univ of Texas, Southwestern Med Ctr of Dallas
Dallas, Texas, 75390, United States
Univ of Washington
Seattle, Washington, 98104, United States
Univ of Puerto Rico
San Juan, 009365067, Puerto Rico
Related Publications (1)
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.
PMID: 14518706BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
John Bartlett
- STUDY CHAIR
Pablo Tebas
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Sponsor Type
- NIH
Study Record Dates
First Submitted
January 17, 2000
First Posted
August 31, 2001
Study Start
November 1, 1999
Study Completion
April 1, 2001
Last Updated
September 9, 2008
Record last verified: 2003-06