Effectiveness of the Early Addition of Abacavir to an Anti-HIV Drug Combination
- Conditions
- HIV Infections
- Registration Number
- NCT00001132
- 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.
- Detailed Description
Combination antiretroviral therapy can offer patients potent suppression of HIV replication and improved immunologic functioning. However, despite aggressive antiretroviral regimens currently in use, only about 50 to 60 percent of patients attain plasma viral loads below 50 copies/ml after 24 weeks. Initiating treatment with a 4-drug regimen may increase this percentage, but this may also contribute to patient non-adherence, drug-related toxicities, potential cross-resistance to drugs used in future regimens, and high financial costs. Another strategy is early intensification (adding a single drug to an existing regimen) in patients who are at risk for attaining incomplete viral suppression after 24 weeks of therapy. ABC may produce a significant antiviral effect when used as an intensification agent in patients on a stable antiretroviral regimen. The results of this study will offer insight into the potential benefits of early treatment intensification.
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 \[AS PER AMENDMENT 1/9/01: or if ABC hypersensitivity is suspected\].\]
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (30)
Univ of Miami School of Medicine
🇺🇸Miami, Florida, United States
Emory Univ
🇺🇸Atlanta, Georgia, United States
Cook County Hosp
🇺🇸Chicago, Illinois, United States
State of MD Div of Corrections / Johns Hopkins Univ Hosp
🇺🇸Baltimore, Maryland, United States
Philadelphia Veterans Administration Med Ctr
🇺🇸Philadelphia, Pennsylvania, United States
Univ of Pennsylvania at Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Vanderbilt Univ Med Ctr
🇺🇸Nashville, Tennessee, United States
Stanford Univ Med Ctr
🇺🇸Stanford, California, United States
Univ of Texas, Southwestern Med Ctr of Dallas
🇺🇸Dallas, Texas, United States
Univ of Washington
🇺🇸Seattle, Washington, United States
San Mateo AIDS Program / Stanford Univ
🇺🇸Stanford, California, United States
St Louis Regional Hosp / St Louis Regional Med Ctr
🇺🇸St Louis, Missouri, United States
Julio Arroyo
🇺🇸West Columbia, South Carolina, United States
Aaron Diamond AIDS Rsch Ctr / Rockefeller Univ
🇺🇸New York, New York, United States
SUNY / Erie County Med Ctr at Buffalo
🇺🇸Buffalo, New York, United States
UCLA CARE Ctr
🇺🇸Los Angeles, California, United States
Harbor UCLA Med Ctr
🇺🇸Torrance, California, United States
Willow Clinic
🇺🇸Menlo Park, California, United States
Univ of Cincinnati
🇺🇸Cincinnati, Ohio, United States
Univ of Puerto Rico
🇵🇷San Juan, Puerto Rico
Univ of Rochester Medical Center
🇺🇸Rochester, New York, United States
Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium
🇺🇸San Jose, California, United States
Univ of Colorado Health Sciences Ctr
🇺🇸Denver, Colorado, United States
Northwestern Univ Med School
🇺🇸Chicago, Illinois, United States
Johns Hopkins Hosp
🇺🇸Baltimore, Maryland, 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
Univ of North Carolina
🇺🇸Chapel Hill, North Carolina, United States
Columbia Presbyterian Med Ctr
🇺🇸New York, New York, United States
Duke Univ Med Ctr
🇺🇸Durham, North Carolina, United States