A Randomized, Double-Blind, Four-Arm Study Comparing Combination Nucleoside, Alternating Nucleoside, and Triple-Drug Therapy for the Treatment of Advanced HIV Disease (CD4 <= 50/mm3)
- Conditions
- HIV Infections
- Registration Number
- NCT00000781
- Brief Summary
To determine the relative clinical efficacy of zidovudine ( AZT ) plus didanosine (ddI), AZT plus zalcitabine ( ddC ), AZT alternating monthly with ddI, and AZT/ddI plus nevirapine in HIV-infected patients with advanced disease.
The rapid emergence of resistant HIV strains has been observed in patients receiving monotherapy with a nucleoside analog or non-nucleoside reverse transcriptase inhibitor. Use of combination therapy with two nucleoside drugs or convergent combination therapy with two nucleosides and a non-nucleoside RT inhibitor may minimize the evolution of these resistant HIV strains. Since toxicity is a major problem in patients with advanced disease who are receiving combination nucleoside therapy, alternating the two drugs may provide a way of retaining several benefits of combination therapy while minimizing the increased toxicity.
- Detailed Description
The rapid emergence of resistant HIV strains has been observed in patients receiving monotherapy with a nucleoside analog or non-nucleoside reverse transcriptase inhibitor. Use of combination therapy with two nucleoside drugs or convergent combination therapy with two nucleosides and a non-nucleoside RT inhibitor may minimize the evolution of these resistant HIV strains. Since toxicity is a major problem in patients with advanced disease who are receiving combination nucleoside therapy, alternating the two drugs may provide a way of retaining several benefits of combination therapy while minimizing the increased toxicity.
Patients are randomized to receive either AZT/ddC, AZT/ddI, AZT alternating monthly with ddI, or AZT/ddI/nevirapine. Patients are evaluated at week 0 and every 4 weeks thereafter for 2 years. Pharmacologic, virologic, and macroneurologic substudies will be conducted. Patients who are already enrolled on protocol ACTG 193 will be given the option of continuing on their originally assigned ACTG 193 therapy for an additional 6 months or undergoing re-randomization to one of the four treatment arms on ACTG 193A.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1292
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 (96)
Beth Israel Deaconess - West Campus
🇺🇸Boston, Massachusetts, United States
Univ of Pennsylvania at Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Univ of Puerto Rico
🇵🇷San Juan, Puerto Rico
Northern Wisconsin Hemophilia Ctr / Saint Vincent's Hosp
🇺🇸Green Bay, Wisconsin, United States
Univ of Texas Galveston
🇺🇸Galveston, Texas, United States
Univ of Tennessee / E Tennessee Comprehensive Hemophilia Ctr
🇺🇸Knoxville, Tennessee, United States
Girard Med Ctr
🇺🇸Philadelphia, Pennsylvania, United States
Thomas Jefferson Univ Hosp
🇺🇸Philadelphia, Pennsylvania, United States
Med Univ of South Carolina / UNC
🇺🇸Charleston, South Carolina, United States
Meharry Med College
🇺🇸Nashville, Tennessee, United States
Great Lakes Hemophilia Foundation
🇺🇸Wauwatosa, Wisconsin, United States
Milton S Hershey Med Ctr
🇺🇸Hershey, Pennsylvania, United States
Saint Michael's Med Ctr / Milton S Hershey Med Ctr
🇺🇸Hershey, Pennsylvania, United States
Julio Arroyo
🇺🇸West Columbia, South Carolina, United States
Univ of Washington
🇺🇸Seattle, Washington, United States
San Francisco Gen Hosp
🇺🇸San Francisco, California, United States
Univ of Minnesota
🇺🇸Minneapolis, Minnesota, United States
St Louis Regional Hosp / St Louis Regional Med Ctr
🇺🇸Saint Louis, Missouri, United States
Robert Wood Johnson Med School / Hershey Med Ctr
🇺🇸New Brunswick, New Jersey, United States
St Paul Ramsey Med Ctr
🇺🇸Saint Paul, Minnesota, United States
Children's Hosp of Los Angeles
🇺🇸Los Angeles, California, United States
Univ of Southern California / LA County USC Med Ctr
🇺🇸Los Angeles, California, United States
Huntington Memorial Hosp / Children's Hosp of Los Angeles
🇺🇸Pasadena, California, United States
Univ of California / San Diego Treatment Ctr
🇺🇸San Diego, California, 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
Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium
🇺🇸San Jose, California, United States
San Mateo AIDS Program / Stanford Univ
🇺🇸Stanford, California, United States
Olive View Med Ctr
🇺🇸Sylmar, California, United States
Harbor UCLA Med Ctr
🇺🇸Torrance, California, United States
Yale Univ / New Haven
🇺🇸New Haven, Connecticut, United States
HIV Ctr - District of Columbia Gen Hosp
🇺🇸Washington, District of Columbia, United States
Whitman - Walker Clinic / Georgetown Univ Med Ctr
🇺🇸Washington, District of Columbia, United States
Georgetown Univ Med Ctr
🇺🇸Washington, District of Columbia, United States
George Washington Univ / Hershey Med Ctr
🇺🇸Washington, District of Columbia, United States
Univ of Miami School of Medicine
🇺🇸Miami, Florida, United States
Howard Univ
🇺🇸Washington, District of Columbia, United States
Univ of Hawaii
🇺🇸Honolulu, Hawaii, United States
Northwestern Univ Med School
🇺🇸Chicago, Illinois, United States
Cook County Hosp
🇺🇸Chicago, Illinois, United States
Rush Presbyterian - Saint Luke's Med Ctr
🇺🇸Chicago, Illinois, United States
Louis A Weiss Memorial Hosp
🇺🇸Chicago, Illinois, United States
Indiana Univ Hosp
🇺🇸Indianapolis, Indiana, United States
Univ of Louisville / East Tennesee Comprehensive Hem Ctr
🇺🇸Louisville, Kentucky, United States
Harvard (Massachusetts Gen Hosp)
🇺🇸Boston, Massachusetts, United States
Boston Med Ctr
🇺🇸Boston, Massachusetts, United States
Worcester Memorial Hosp / Med Ctr of Cntrl MA-Memorial
🇺🇸Worcester, Massachusetts, United States
Hennepin County Med Clinic
🇺🇸Minneapolis, Minnesota, United States
Dartmouth - Hitchcock Med Ctr / Med Ctr Cntrl Massachusetts
🇺🇸Lebanon, New Hampshire, United States
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
🇺🇸Newark, New Jersey, United States
Adirondack Med Ctr at Saranac Lake
🇺🇸Albany, New York, United States
Albany Med College / Division of HIV Medicine A158
🇺🇸Albany, New York, United States
Mid - Hudson Care Ctr
🇺🇸Albany, New York, United States
Bronx Municipal Hosp Ctr/Jacobi Med Ctr
🇺🇸Bronx, New York, United States
Comprehensive Health Care Ctr / Bronx Municipal Hosp
🇺🇸Bronx, New York, United States
Montefiore Drug Treatment Ctr / Bronx Municipal Hosp
🇺🇸Bronx, New York, United States
Montefiore Family Health Ctr / Bronx Municipal Hosp
🇺🇸Bronx, New York, United States
Samaritan Village Inc / Bronx Municipal Hosp
🇺🇸Bronx, New York, United States
Jack Weiler Hosp / Bronx Municipal Hosp
🇺🇸Bronx, New York, United States
Montefiore Med Ctr / Bronx Municipal Hosp
🇺🇸Bronx, New York, United States
Montefiore Med Ctr Adolescent AIDS Program
🇺🇸Bronx, New York, United States
North Central Bronx Hosp / Bronx Municipal Hosp
🇺🇸Bronx, New York, United States
Bronx Veterans Administration / Mount Sinai Hosp
🇺🇸Bronx, New York, United States
SUNY / Health Sciences Ctr at Brooklyn
🇺🇸Brooklyn, New York, United States
SUNY / Erie County Med Ctr at Buffalo
🇺🇸Buffalo, New York, United States
Beth Israel Med Ctr
🇺🇸New York, New York, United States
City Hosp Ctr at Elmhurst / Mount Sinai Hosp
🇺🇸Elmhurst, New York, United States
North Shore Univ Hosp
🇺🇸Manhasset, New York, United States
Bellevue Hosp / New York Univ Med Ctr
🇺🇸New York, New York, United States
Cornell Univ Med Ctr
🇺🇸New York, New York, United States
Mount Sinai Med Ctr / Hemophilia Treatment Ctr
🇺🇸New York, New York, United States
Mount Sinai Med Ctr
🇺🇸New York, New York, United States
Columbia Presbyterian Med Ctr
🇺🇸New York, New York, United States
Harlem Hosp 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
SUNY / State Univ of New York
🇺🇸Syracuse, New York, United States
Moses H Cone Memorial Hosp
🇺🇸Greensboro, North Carolina, United States
Univ of Cincinnati
🇺🇸Cincinnati, Ohio, United States
Univ of Kentucky Lexington
🇺🇸Cincinnati, Ohio, United States
Case Western Reserve Univ
🇺🇸Cleveland, Ohio, United States
MetroHealth Med Ctr
🇺🇸Cleveland, Ohio, United States
Columbus Children's Hosp
🇺🇸Columbus, Ohio, United States
Med College of Ohio
🇺🇸Toledo, Ohio, United States
Univ of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Denver Dept of Health and Hosps
🇺🇸Denver, Colorado, United States
Mountain States Reg Hemo Ctr / Univ of Colorado
🇺🇸Denver, Colorado, United States
Univ of South Florida
🇺🇸Tampa, Florida, United States
Rose Med Ctr
🇺🇸Denver, Colorado, United States
Univ of Colorado Health Sciences Ctr
🇺🇸Denver, Colorado, United States
Univ of Nebraska Med Ctr
🇺🇸Omaha, Nebraska, United States
Stanford Univ Med Ctr
🇺🇸Stanford, California, United States
Methodist Hosp of Indiana / Life Care Clinic
🇺🇸Indianapolis, Indiana, United States
Univ Texas Health Science Ctr / Univ Texas Med School
🇺🇸Houston, Texas, 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