Virologic Responses To New Nucleoside Regimens After Prolonged ZDV or ddI Monotherapy
- Conditions
- HIV Infections
- Registration Number
- NCT00000831
- Brief Summary
To elucidate the relationship between virologic risk factors and immunologic and clinical progression in patients receiving monotherapy in protocol ACTG 175, and to compare new treatment regimens with combinations of reverse transcriptase inhibitors in long-term recipients of monotherapy. Specifically, to determine, in patients who have been taking zidovudine (AZT) alone for a long time, whether it is beneficial to add lamivudine (3TC) to AZT or to switch to d4T alone, and also to determine, in patients who have been taking didanosine (ddI) alone for a long time, whether it is beneficial to add AZT or AZT/3TC to ddI.
Characteristics of virus replication, pathogenicity, and resistance are thought to determine the durability of virologic and clinical response to nucleoside reverse transcriptase inhibitors. Previous results of ACTG 175 suggest that either a switch to ddI or addition of ddI in patients receiving AZT results in better clinical, virologic, and CD4 cell response compared to continuation of AZT alone.
- Detailed Description
Characteristics of virus replication, pathogenicity, and resistance are thought to determine the durability of virologic and clinical response to nucleoside reverse transcriptase inhibitors. Previous results of ACTG 175 suggest that either a switch to ddI or addition of ddI in patients receiving AZT results in better clinical, virologic, and CD4 cell response compared to continuation of AZT alone.
Patients with prior AZT experience only are randomized to receive either d4T alone or AZT/3TC. Patients with prior ddI experience only are randomized to receive ddI/AZT or ddI/AZT/3TC. PER AMENDMENT 8/27/96: The study has been extended 6 months and treatment will be available until March 15, 1997 at the latest. Each patient will have regularly scheduled 12 week safety visits during the extension period.
AS PER AMENDMENT 1/22/97: The study has been extended for approximately 16 additional weeks beyond the current 6-month extension. Subjects will be unblinded to their assigned regimen beginning 2/21/97 and will continue therapy for up to 16 weeks in open-label fashion. AS PER AMENDMENT 5/9/97: The study has been extended for an additional 8 weeks; study drug will not be provided after 9/15/97.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 280
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 (40)
USC CRS
馃嚭馃嚫Los Angeles, California, United States
Regional Center for Infectious Disease, Wendover Medical Center CRS
馃嚭馃嚫Greensboro, North Carolina, United States
Beth Israel Deaconess - East Campus A0102 CRS
馃嚭馃嚫Boston, Massachusetts, United States
UCLA CARE Center CRS
馃嚭馃嚫Los Angeles, California, United States
Stanford CRS
馃嚭馃嚫Palo Alto, California, United States
Santa Clara Valley Med. Ctr.
馃嚭馃嚫San Jose, California, United States
Harbor-UCLA Med. Ctr. CRS
馃嚭馃嚫Torrance, California, United States
San Mateo County AIDS Program
馃嚭馃嚫San Mateo, California, United States
Emory Univ. Hemophilia Program Office
馃嚭馃嚫Atlanta, Georgia, United States
Northwestern University CRS
馃嚭馃嚫Chicago, Illinois, United States
Cook County Hosp. CORE Ctr.
馃嚭馃嚫Chicago, Illinois, United States
Rush Univ. Med. Ctr. ACTG CRS
馃嚭馃嚫Chicago, Illinois, United States
Massachusetts General Hospital ACTG CRS
馃嚭馃嚫Boston, Massachusetts, United States
Bmc Actg Crs
馃嚭馃嚫Boston, Massachusetts, United States
Beth Israel Deaconess Med. Ctr., ACTG CRS
馃嚭馃嚫Boston, Massachusetts, United States
St. Louis ConnectCare, Infectious Diseases Clinic
馃嚭馃嚫Saint Louis, Missouri, United States
SUNY - Buffalo, Erie County Medical Ctr.
馃嚭馃嚫Buffalo, New York, United States
Washington U CRS
馃嚭馃嚫Saint Louis, Missouri, United States
NY Univ. HIV/AIDS CRS
馃嚭馃嚫New York, New York, United States
Cornell University A2201
馃嚭馃嚫New York, New York, United States
Univ. of Rochester ACTG CRS
馃嚭馃嚫Rochester, New York, United States
Carolinas HealthCare System, Carolinas Med. Ctr.
馃嚭馃嚫Charlotte, North Carolina, United States
The Ohio State Univ. AIDS CRS
馃嚭馃嚫Columbus, Ohio, United States
Hosp. of the Univ. of Pennsylvania CRS
馃嚭馃嚫Philadelphia, Pennsylvania, United States
Case CRS
馃嚭馃嚫Cleveland, Ohio, United States
Puerto Rico-AIDS CRS
馃嚨馃嚪San Juan, Puerto Rico
Mbeya Med. Research Program, Mbeya Referral Hosp. CRS
馃嚬馃嚳Mbeya, Tanzania
Ucsd, Avrc Crs
馃嚭馃嚫San Diego, California, United States
Univ. of Miami AIDS CRS
馃嚭馃嚫Miami, Florida, United States
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
馃嚭馃嚫Indianapolis, Indiana, United States
Univ. of Cincinnati CRS
馃嚭馃嚫Cincinnati, Ohio, United States
University of Washington AIDS CRS
馃嚭馃嚫Seattle, Washington, United States
Alabama Therapeutics CRS
馃嚭馃嚫Birmingham, Alabama, United States
Ucsf Aids Crs
馃嚭馃嚫San Francisco, California, United States
University of Minnesota, ACTU
馃嚭馃嚫Minneapolis, Minnesota, United States
Univ. of Nebraska Med. Ctr., Durham Outpatient Ctr.
馃嚭馃嚫Omaha, Nebraska, United States
University of Colorado Hospital CRS
馃嚭馃嚫Aurora, Colorado, United States
Tulane Hemophilia Treatment Ctr.
馃嚭馃嚫New Orleans, Louisiana, United States
Unc Aids Crs
馃嚭馃嚫Chapel Hill, North Carolina, United States
Johns Hopkins Adult AIDS CRS
馃嚭馃嚫Baltimore, Maryland, United States