The Effectiveness of Three Drug Combinations in HIV-Infected Patients Who Have Taken Zidovudine for More Than 12 Weeks
- Conditions
- HIV Infections
- Registration Number
- NCT00001063
- Brief Summary
To compare the effect of stavudine (d4T) alone or with zidovudine (AZT) versus didanosine (ddI) alone or with AZT on CD4 counts, HIV RNA levels, and viral load in HIV-infected patients \[AS PER AMENDMENT 3/21/97: To compare the effects of d4T alone versus ddI alone versus AZT plus ddI\]. To compare the safety of d4T/AZT. AS PER AMENDMENT 3/21/97: To evaluate the pharmacokinetic interactions of AZT and d4T both at an extracellular and intracellular level.
Although AZT and ddI can delay the advancement of HIV disease, the benefit of either of these drugs has proven to be only temporary. d4T, a new nucleoside analog with a favorable toxicity profile and demonstrated activity against HIV, offers an additional therapeutic option. It is reasonably assumed that the benefit of an antiretroviral agent in terms of delaying clinical disease progression is directly related to its ability to achieve and sustain viral suppression; thus, this study measures effects on viral load and CD4 count.
- Detailed Description
Although AZT and ddI can delay the advancement of HIV disease, the benefit of either of these drugs has proven to be only temporary. d4T, a new nucleoside analog with a favorable toxicity profile and demonstrated activity against HIV, offers an additional therapeutic option. It is reasonably assumed that the benefit of an antiretroviral agent in terms of delaying clinical disease progression is directly related to its ability to achieve and sustain viral suppression; thus, this study measures effects on viral load and CD4 count.
Patients are randomized in a blinded fashion to receive AZT or placebo in combination with open-label d4T or ddI for up to 48 weeks. AS PER AMENDMENT 3/21/97: The study is now composed of three arms: open-label d4T versus open-label ddI plus blinded AZT placebo versus blinded AZT plus open-label ddI. Patients originally assigned to the d4T + AZT arm, which was closed 10/96, will be given the option of discontinuing AZT and remaining on d4T monotherapy or discontinuing all study drugs. In addition, all study participants will be asked to participate in a pharmacology substudy.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
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 (33)
Massachusetts General Hospital ACTG CRS
🇺🇸Boston, Massachusetts, United States
Bmc Actg Crs
🇺🇸Boston, Massachusetts, United States
Beth Israel Deaconess Med. Ctr., ACTG CRS
🇺🇸Boston, Massachusetts, United States
University of Washington AIDS CRS
🇺🇸Seattle, Washington, United States
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
🇺🇸Indianapolis, Indiana, United States
Ucsd, Avrc Crs
🇺🇸San Diego, California, United States
Univ. of Cincinnati CRS
🇺🇸Cincinnati, Ohio, United States
UCLA CARE Center CRS
🇺🇸Los Angeles, California, United States
Stanford CRS
🇺🇸Palo Alto, California, United States
Harbor-UCLA Med. Ctr. CRS
🇺🇸Torrance, California, United States
Children's National Med. Ctr., ACTU
🇺🇸Washington, District of Columbia, United States
Univ. of Florida Jacksonville NICHD CRS
🇺🇸Jacksonville, Florida, United States
Univ. of Miami AIDS CRS
🇺🇸Miami, Florida, United States
Northwestern University CRS
🇺🇸Chicago, Illinois, United States
Cook County Hosp. CORE Ctr.
🇺🇸Chicago, Illinois, United States
Rush Univ. Med. Ctr. ACTG CRS
🇺🇸Chicago, Illinois, United States
Indiana Univ. School of Medicine, Wishard Memorial
🇺🇸Indianapolis, Indiana, United States
Methodist Hosp. of Indiana
🇺🇸Indianapolis, Indiana, United States
St. Louis ConnectCare, Infectious Diseases Clinic
🇺🇸Saint Louis, Missouri, United States
Washington U CRS
🇺🇸Saint Louis, Missouri, United States
SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS
🇺🇸Brooklyn, New York, United States
SUNY - Buffalo, Erie County Medical Ctr.
🇺🇸Buffalo, New York, United States
Puerto Rico-AIDS CRS
🇵🇷San Juan, Puerto Rico
San Juan City Hosp. PR NICHD CRS
🇵🇷San Juan, Puerto Rico
Univ. of Rochester ACTG CRS
🇺🇸Rochester, New York, United States
Weiss Memorial Hosp.
🇺🇸Chicago, Illinois, United States
The Ohio State Univ. AIDS CRS
🇺🇸Columbus, Ohio, United States
Hennepin County Med. Ctr., Div. of Infectious Diseases
🇺🇸Minneapolis, Minnesota, United States
Tulane Hemophilia Treatment Ctr.
🇺🇸New Orleans, Louisiana, United States
Ucsf Aids Crs
🇺🇸San Francisco, California, United States
University of Colorado Hospital CRS
🇺🇸Aurora, Colorado, United States
Univ. of Hawaii at Manoa, Leahi Hosp.
🇺🇸Honolulu, Hawaii, United States
University of Minnesota, ACTU
🇺🇸Minneapolis, Minnesota, United States