A Study to Compare The Ability of Different Anti-HIV Drugs to Decrease Viral Load After Nelfinavir (an Anti-HIV Drug)Treatment Failure
- Conditions
- HIV Infections
- Registration Number
- NCT00000918
- Brief Summary
The purpose of this study is to determine the safety and effectiveness of combining several anti-HIV drugs in order to decrease plasma viral load (level of HIV in the blood) in HIV-positive patients who have failed nelfinavir (NFV) treatment.
In order to determine the ability of a drug regimen to decrease viral load after drug treatment has failed, it is best to test a variety different of drug "cocktails" (drug regimens). The drug cocktails in this study include 2 new nucleoside reverse transcriptase inhibitors (NRTIs), efavirenz (an NNRTI, non-nucleoside reverse transcriptase inhibitor), and either 1 or 2 protease inhibitors. It is important to include multiple drugs from different groups in a drug cocktail since combinations containing fewer drugs are likely to fail.
- Detailed Description
To maximize the likelihood of a favorable response to salvage therapy, 4 or 5 drug regimens should be studied. Regimens containing fewer drugs, particularly those lacking a non-nucleoside reverse transcriptase inhibitor (NNRTI) such as efavirenz, are likely to result in an unacceptable rate of virological failure. Therefore, this study examines drug combinations which include two new nucleoside reverse transcriptase inhibitors (NRTIs), the NNRTI efavirenz, and either one or two protease inhibitors which are known not to produce cross-resistance to nelfinavir.
Patients are randomly selected to receive 1 of the following 4 treatment regimens:
Arm A: Ritonavir, saquinavir, efavirenz, and 2 new NRTIs. Arm B: Indinavir, efavirenz and 2 new NRTIs. Arm C: Amprenavir, efavirenz, and 2 new NRTIs. \[AS PER AMENDMENT 3/22/00: Patients have the option to increase the APV dose or to add low-dose ritonavir. APV will continue to be provided by the study; ritonavir will not be provided by the study.\] Arm D: Indinavir, amprenavir, efavirenz, and 2 new NRTIs. \[AS PER AMENDMENT 6/28/99: All treatment regimens must include at least 1 new NRTI.\] \[AS PER AMENDMENT 3/22/00: ACTG 400 will continue to provide originally randomized study medications to all patients until approximately May 10, 2000, regardless of virologic response. Patients may also add antiretrovirals of their choice to this regimen (not provided by the study).\] Clinical assessments are taken at Weeks 2, 4, 8, 12, 16, and every 8 weeks thereafter for the duration of the study. In addition, 2 substudies are being conducted: a drug-interaction substudy and a drug-exposure substudy. \[AS PER AMENDMENT 3/22/00: Both substudies are closed to accrual and their pharmacokinetics assessments are discontinued.\]
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 300
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
Related Research Topics
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Trial Locations
- Locations (39)
UCLA CARE Ctr
🇺🇸Los Angeles, California, United States
Univ of Miami School of Medicine
🇺🇸Miami, Florida, United States
Cook County Hosp
🇺🇸Chicago, Illinois, United States
Case Western Reserve Univ
🇺🇸Cleveland, Ohio, United States
Univ of Pennsylvania at Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Division of Inf Diseases/ Indiana Univ Hosp
🇺🇸Indianapolis, Indiana, United States
Methodist Hosp of Indiana / Life Care Clinic
🇺🇸Indianapolis, Indiana, United States
Beth Israel Deaconess - West Campus
🇺🇸Boston, Massachusetts, United States
Marin County Specialty Clinic
🇺🇸San Rafael, California, United States
Emory Univ
🇺🇸Atlanta, Georgia, United States
Rush Presbyterian - Saint Luke's Med Ctr
🇺🇸Chicago, Illinois, United States
Harvard (Massachusetts Gen Hosp)
🇺🇸Boston, Massachusetts, United States
Univ of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Northwestern Univ Med School
🇺🇸Chicago, Illinois, United States
Indiana Univ Hosp
🇺🇸Indianapolis, Indiana, United States
Ohio State Univ Hosp Clinic
🇺🇸Columbus, Ohio, United States
Univ of Washington
🇺🇸Seattle, Washington, United States
Univ of Colorado Health Sciences Ctr
🇺🇸Denver, Colorado, United States
San Francisco AIDS Clinic / San Francisco Gen Hosp
🇺🇸San Francisco, California, United States
Univ of Southern California / LA County USC Med Ctr
🇺🇸Los Angeles, California, United States
Willow Clinic
🇺🇸Menlo Park, California, United States
San Francisco Gen Hosp
🇺🇸San Francisco, 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
Howard Univ
🇺🇸Washington, District of Columbia, 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
Cornell Univ Med Ctr
🇺🇸New York, New York, United States
Chelsea Ctr
🇺🇸New York, 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
Mount Sinai 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
Julio Arroyo
🇺🇸West Columbia, South Carolina, United States
Univ of Puerto Rico
🇵🇷San Juan, Puerto Rico