A Study on Amprenavir in Combination With Other Anti-HIV Drugs in HIV-Positive Patients
- Conditions
- HIV Infections
- Registration Number
- NCT00000912
- Brief Summary
The purpose of this study is to compare 4 different combinations of anti-HIV drugs and to determine the number of people whose HIV blood levels decrease to 200 copies/ml or less while on the treatment. This study evaluates the safety of these drug combinations, which include an experimental protease inhibitor (PI), amprenavir.
Despite the success that many patients have had with PI treatment regimens, there is still a possibility that patients receiving PIs may continue to have high HIV blood levels. Because of this possibility, alternative drug combinations containing PIs are being studied. It appears that amprenavir, when taken with 3 or 4 other anti-HIV drugs, may be effective in patients with prior PI treatment experience.
- Detailed Description
A number of studies both within and outside the ACTG have been initiated or are in development to try to address the issue of alternative treatments for patients who either do not achieve or lose virologic control while receiving protease inhibitors (PIs). Amprenavir (APV) is an attractive candidate to investigate as part of salvage regimens because: 1) it has substantial antiretroviral activity; 2) there are preliminary in vitro and in vivo data that suggest that resistance to this agent may be mediated in part by a unique mutation (I50V); and 3) its cross-resistance profile to the approved PIs is uncertain.
Patients are selectively randomized to 1 of 4 study arms based on prior PI experience. Those randomized to Arms A, B, or C receive 2 PIs, 1 of which is amprenavir (APV), and those randomized to Arm D receive a single PI (APV) as part of their treatment regimen, as follows:
Arm A: APV plus saquinavir soft gel capsule (SQVsgc) plus abacavir (ABC) plus efavirenz (EFV) plus adefovir (ADV).
Arm B: APV plus indinavir (IDV) plus ABC plus EFV plus ADV. Arm C: APV plus nelfinavir (NFV) plus ABC plus EFV plus ADV. Arm D: APV plus placebo (NFV, IDV, or SQVsgc) plus ABC plus EFV plus ADV. All patients receive L-carnitine supplementation. All patients receive clinical physical assessments and laboratory testing during study as follows: Weeks 2, 4, and every 4 weeks thereafter. A primary analysis is performed after the last patient has reached 24 weeks. \[AS PER AMENDMENT 3/2/00: At that time, all patients are unblinded to their original treatment assignment.\] Patients who experience virologic failure are unblinded and may choose 1 of the following 3 options: Continue study medications open-label, permanently discontinue study medications, or selectively continue study medications \[AS PER AMENDMENT 3/2/00: from the arm the patient was originally randomized to\] and combine with other approved antiretroviral agents. \[AS PER AMENDMENT 3/2/00: For patients adding didanosine (ddI) to their regimens, monitoring for the development of pancreatitis is crucial.\] Final evaluations are required for those patients who are off drug during the immediate 8-week period following the last dose of study treatment. Beyond 8 weeks, they are followed for incidence of death, cancer, congenital anomalies, and permanent disabilities. \[AS PER AMENDMENT 3/2/00: Gilead Sciences has terminated its U.S. development of ADV for HIV infection. Gilead will continue to supply ADV for patients in ACTG 398 until the study closes. Patients who are receiving ADV at the completion of the study may continue to access ADV through the Expanded Access Program, provided that the physician and patient have determined that continued use of ADV is beneficial.\]
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 475
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 (45)
USC Univ Hosp & Ambulatory Hlth Care Ctr / USC Med Ctr
🇺🇸Los Angeles, California, United States
Emory Univ
🇺🇸Atlanta, Georgia, United States
UCLA CARE Ctr
🇺🇸Los Angeles, California, United States
Univ of Pittsburgh Med Ctr
🇺🇸Pittsburgh, Pennsylvania, United States
Cook County Hosp
🇺🇸Chicago, Illinois, United States
Boston Med Ctr
🇺🇸Boston, Massachusetts, United States
Univ of Southern California / LA County USC Med Ctr
🇺🇸Los Angeles, California, United States
San Francisco AIDS Clinic / San Francisco Gen Hosp
🇺🇸San Francisco, California, United States
Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium
🇺🇸San Jose, California, United States
Stanford Univ Med Ctr
🇺🇸Stanford, California, United States
Howard Univ
🇺🇸Washington, District of Columbia, United States
Univ of Miami School of Medicine
🇺🇸Miami, Florida, United States
Univ of Colorado Health Sciences Ctr
🇺🇸Denver, Colorado, United States
Univ of Hawaii
🇺🇸Honolulu, Hawaii, United States
Charity Hosp / Tulane Univ Med School
🇺🇸New Orleans, Louisiana, United States
Rush Presbyterian - Saint Luke's Med Ctr
🇺🇸Chicago, Illinois, United States
St Louis Regional Hosp / St Louis Regional Med Ctr
🇺🇸Saint Louis, Missouri, United States
Bellevue Hosp / New York Univ Med Ctr
🇺🇸New York, New York, United States
SUNY / Erie County Med Ctr at Buffalo
🇺🇸Buffalo, New York, United States
Mem Sloan - Kettering Cancer Ctr
🇺🇸New York, New York, United States
Cornell Univ Med Ctr
🇺🇸New York, New York, United States
Chelsea Ctr
🇺🇸New York, New York, United States
Ohio State Univ Hosp Clinic
🇺🇸Columbus, Ohio, United States
Univ of Pennsylvania at Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Univ of Cincinnati
🇺🇸Cincinnati, Ohio, United States
Duke Univ Med Ctr
🇺🇸Durham, North Carolina, United States
Milton S Hershey Med Ctr
🇺🇸Hershey, Pennsylvania, United States
Univ of Rochester Medical Center
🇺🇸Rochester, New York, United States
Univ of Washington
🇺🇸Seattle, Washington, United States
Univ of Texas Galveston
🇺🇸Galveston, Texas, United States
Northwestern Univ Med School
🇺🇸Chicago, Illinois, United States
Univ of California / San Diego Treatment Ctr
🇺🇸San Diego, California, United States
San Mateo AIDS Program / Stanford Univ
🇺🇸Stanford, California, United States
Willow Clinic
🇺🇸Menlo Park, California, United States
San Francisco Gen Hosp
🇺🇸San Francisco, California, United States
Emory Hemo Comp Evaluation Clinic / East TN Comp Hemo Ctr
🇺🇸Atlanta, Georgia, United States
Queens Med Ctr
🇺🇸Honolulu, Hawaii, United States
Tripler Army Med Ctr
🇺🇸Tripler AMC, Hawaii, United States
Tulane Univ School of Medicine
🇺🇸New Orleans, Louisiana, United States
Univ of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Johns Hopkins Hosp
🇺🇸Baltimore, Maryland, United States
Harvard (Massachusetts Gen Hosp)
🇺🇸Boston, Massachusetts, United States
Mount Sinai Med Ctr
🇺🇸New York, New York, United States
Univ of Puerto Rico
🇵🇷San Juan, Puerto Rico
Moses H Cone Memorial Hosp
🇺🇸Greensboro, North Carolina, United States