A Study of Indinavir Sulfate Plus Zidovudine (AZT) Plus Lamivudine in HIV-Infected Patients Who Have Taken AZT for Six or More Months
- Conditions
- HIV Infections
- Registration Number
- NCT00000841
- Brief Summary
To determine the clinical efficacy of indinavir sulfate or placebo in combination with zidovudine ( AZT ) and lamivudine ( 3TC ) in AIDS patients.
Protease inhibitors such as indinavir sulfate may be effective in patients with advanced HIV disease who have received prior AZT therapy. Since studies suggest that triple drug therapy may have an advantage over both monotherapy and two drug therapy, the combination of indinavir sulfate with AZT and 3TC should be evaluated.
- Detailed Description
Protease inhibitors such as indinavir sulfate may be effective in patients with advanced HIV disease who have received prior AZT therapy. Since studies suggest that triple drug therapy may have an advantage over both monotherapy and two drug therapy, the combination of indinavir sulfate with AZT and 3TC should be evaluated.
Patients are randomized to receive open-label AZT and 3TC with or without indinavir sulfate for at least 48 weeks. Patients who develop intolerance to AZT or have progressive disease after 24 weeks on study may substitute stavudine ( d4T ) for AZT. Patients are followed at weeks 4, 8, 16, 24, 32, 40, and 48 and every 8 weeks thereafter up to week 96. \[AS PER 02/25/97 AMENDMENT: Accrual has been halted because interim analysis has shown triple therapy superior to double-agent therapy. An open label extension phase has been added for the period through 06/30/97. Patients who had been randomized to AZT/3TC are given the option of continuing on assigned ACTG 320 study drugs, crossing over to open-label indinavir, or permanently discontinuing all study therapies and going off study. Patients who were randomized to AZT/3TC plus indinavir or who were crossed to such therapy are given the option of continuing their currently assigned therapies. It is strongly suggested that patients who were on AZT/3TC who wish to receive open-label indinavir consider changing the nucleoside analog component of their regimen if at all possible.\] \[ AS PER 06/06/97 AMENDMENT: The availability of the current ACTG 320 treatment has been further extended for approximately 12 additional weeks (but not beyond 09/30/97). This extension will allow patients to continue receiving study medications until ACTG 372 is open to accrual (the rollover protocol for subjects originally randomized to the triple drug component of ACTG 320 or who are crossed over due to a confirmed study endpoint is finalized).\] \[ AS PER 09/15/97 AMENDMENT: Open-label therapy will be provided for no more than 90 days beyond the enrollment of the first subject on ACTG 372.\]
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1750
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 (87)
Univ of Southern California / LA County USC Med Ctr
🇺🇸Los Angeles, California, United States
UCLA CARE Ctr
🇺🇸Los Angeles, California, United States
Emory Univ
🇺🇸Atlanta, Georgia, United States
Emory Hemo Comp Evaluation Clinic / East TN Comp Hemo Ctr
🇺🇸Atlanta, Georgia, United States
Louis A Weiss Memorial Hosp
🇺🇸Chicago, Illinois, United States
Johns Hopkins Hosp
🇺🇸Baltimore, Maryland, United States
Harvard (Massachusetts Gen Hosp)
🇺🇸Boston, Massachusetts, United States
Boston Med Ctr
🇺🇸Boston, Massachusetts, United States
Univ of Miami School of Medicine
🇺🇸Miami, Florida, United States
Indiana Univ Hosp
🇺🇸Indianapolis, Indiana, United States
Univ of Miami (Pediatric)
🇺🇸Miami, Florida, United States
Division of Inf Diseases/ Indiana Univ Hosp
🇺🇸Indianapolis, Indiana, United States
Univ of Kentucky Lexington
🇺🇸Cincinnati, Ohio, United States
Kaiser Permanente Franklin Med Ctr
🇺🇸Denver, Colorado, United States
Mountain States Reg Hemo Ctr / Univ of Colorado
🇺🇸Denver, Colorado, United States
San Francisco AIDS Clinic / San Francisco Gen Hosp
🇺🇸San Francisco, California, United States
Stanford at Kaiser / Kaiser Permanente Med Ctr
🇺🇸San Francisco, California, United States
Hennepin County Med Clinic
🇺🇸Minneapolis, Minnesota, United States
Univ of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Univ of Nebraska Med Ctr
🇺🇸Omaha, Nebraska, United States
Children's Hosp of Los Angeles
🇺🇸Los Angeles, California, United States
Univ of California / San Diego Treatment Ctr
🇺🇸San Diego, California, United States
Univ of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
San Francisco Gen Hosp
🇺🇸San Francisco, California, United States
Harbor UCLA Med Ctr
🇺🇸Torrance, California, United States
Stanford Univ Med Ctr
🇺🇸Stanford, California, United States
San Mateo AIDS Program / Stanford Univ
🇺🇸Stanford, California, United States
Univ of Colorado Health Sciences Ctr
🇺🇸Denver, Colorado, United States
George Washington Univ / Hershey Med Ctr
🇺🇸Washington, District of Columbia, United States
Georgetown Univ Hosp
🇺🇸Washington, District of Columbia, United States
Northwestern Univ Med School
🇺🇸Chicago, Illinois, United States
Rush Presbyterian - Saint Luke's Med Ctr
🇺🇸Chicago, Illinois, United States
Chicago Children's Memorial Hosp
🇺🇸Chicago, Illinois, United States
Illinois Masonic Med Ctr
🇺🇸Chicago, Illinois, United States
Univ of Iowa Hosp and Clinic
🇺🇸Iowa City, Iowa, United States
Methodist Hosp of Indiana / Life Care Clinic
🇺🇸Indianapolis, Indiana, United States
State of MD Div of Corrections / Johns Hopkins Univ Hosp
🇺🇸Baltimore, Maryland, United States
Beth Israel Deaconess - West Campus
🇺🇸Boston, Massachusetts, United States
Worcester Memorial Hosp / Med Ctr of Cntrl MA-Memorial
🇺🇸Worcester, Massachusetts, United States
St Paul Ramsey Med Ctr
🇺🇸Saint Paul, Minnesota, United States
St Louis Regional Hosp / St Louis Regional Med Ctr
🇺🇸Saint Louis, Missouri, United States
Montefiore Med Ctr Adolescent AIDS Program
🇺🇸Bronx, New York, United States
Bronx Veterans Administration / Mount Sinai Hosp
🇺🇸Bronx, New York, United States
SUNY / Erie County Med Ctr at Buffalo
🇺🇸Buffalo, New York, United States
North Shore Univ Hosp
🇺🇸Great Neck, 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
Manhattan Veterans Administration / New York Univ Med Ctr
🇺🇸New York, New York, United States
Kaplan Cancer Ctr / New York Univ Med Ctr
🇺🇸New York, New York, United States
Saint Clare's Hosp and Health Ctr
🇺🇸New York, New York, United States
Mem Sloan - Kettering Cancer Ctr
🇺🇸New York, New York, United States
Mount Sinai Med Ctr / Pediatrics
🇺🇸New York, New York, United States
Cornell Univ Med Ctr
🇺🇸New York, New York, United States
Univ of Rochester Medical Center
🇺🇸Rochester, New York, United States
Mount Sinai Med Ctr
🇺🇸New York, New York, United States
St Vincent's Hosp / Mem Sloan-Kettering Cancer Ctr
🇺🇸New York, New York, United States
Mount Sinai Med Ctr / Hemophilia Treatment Ctr
🇺🇸New York, New York, United States
Duke Univ Med Ctr
🇺🇸Durham, North Carolina, United States
Carolinas Med Ctr
🇺🇸Charlotte, North Carolina, United States
Harlem Hosp Ctr
🇺🇸New York, New York, United States
SUNY / State Univ of New York
🇺🇸Syracuse, New York, United States
Case Western Reserve Univ
🇺🇸Cleveland, Ohio, United States
Moses H Cone Memorial Hosp
🇺🇸Greensboro, North Carolina, United States
Univ of Cincinnati
🇺🇸Cincinnati, Ohio, United States
Ohio State Univ Hosp Clinic
🇺🇸Columbus, Ohio, United States
Central Prison/Women's Prison in Raleigh / NC
🇺🇸Raleigh, North Carolina, United States
Columbus Children's Hosp
🇺🇸Columbus, Ohio, United States
Thomas Jefferson Univ Hosp
🇺🇸Philadelphia, Pennsylvania, United States
Milton S Hershey Med Ctr
🇺🇸Hershey, Pennsylvania, United States
Meharry Med College
🇺🇸Nashville, Tennessee, United States
Univ of Washington
🇺🇸Seattle, Washington, United States
Univ of Texas Galveston
🇺🇸Galveston, Texas, United States
Univ Texas Health Science Ctr / Univ Texas Med School
🇺🇸Houston, Texas, United States
Vanderbilt Univ Med Ctr
🇺🇸Nashville, Tennessee, United States
Great Lakes Hemophilia Foundation
🇺🇸Wauwatosa, Wisconsin, United States
Ramon Ruiz Arnau Univ Hosp / Pediatrics
🇵🇷Bayamon, Puerto Rico
Univ of Puerto Rico
🇵🇷San Juan, Puerto Rico
Univ of Tennessee / E Tennessee Comprehensive Hemophilia Ctr
🇺🇸Knoxville, Tennessee, United States
Julio Arroyo
🇺🇸West Columbia, South Carolina, United States
Charity Hosp / Tulane Univ Med School
🇺🇸New Orleans, Louisiana, United States
Tulane Med Ctr Hosp
🇺🇸New Orleans, Louisiana, United States
Tulane Univ School of Medicine
🇺🇸New Orleans, Louisiana, United States
Queens Med Ctr
🇺🇸Honolulu, Hawaii, United States
Univ of Hawaii
🇺🇸Honolulu, Hawaii, United States
Univ of North Carolina
🇺🇸Chapel Hill, North Carolina, United States
Med Univ of South Carolina
🇺🇸Charleston, South Carolina, United States
Howard Univ
🇺🇸Washington, District of Columbia, United States