Antiviral Activity of and Resistance to Lamivudine in Combination With Zidovudine, Stavudine, or Didanosine
- Conditions
- HIV Infections
- Registration Number
- NCT00000838
- Brief Summary
To evaluate the efficacy, safety, and pharmacokinetics of lamivudine (3TC) combined with zidovudine (AZT), stavudine (d4T), or didanosine (ddI) in comparison with d4T or ddI monotherapy in HIV-infected patients with no prior nucleoside therapy.
3TC may be uniquely effective in combination with AZT due to the interaction of AZT and 3TC resistance mutations. One explanation is that the M184V mutation, which confers resistance to 3TC, suppresses AZT resistance. This benefit of 3TC may not extend to combination therapy with other nucleoside analogs.
- Detailed Description
3TC may be uniquely effective in combination with AZT due to the interaction of AZT and 3TC resistance mutations. One explanation is that the M184V mutation, which confers resistance to 3TC, suppresses AZT resistance. This benefit of 3TC may not extend to combination therapy with other nucleoside analogs.
Patients are randomized to either a ddI limb or d4T limb, then randomized a second time to one of six treatment arms, as follows: ddI alone, d4T alone, 3TC/AZT (on both ddI and d4T limbs), 3TC/ddI, and 3TC/d4T. Treatment is given for 48 weeks. At study week 24, patients on monotherapy will have 3TC added to their regimen (in a blinded fashion).
PER AMENDMENT 10/18/96: A treatment extension phase has been added to the study design in order to allow subjects who complete 48 weeks of therapy to remain on their same blinded treatment until approximately 2 months after the last enrolled subject completes 48 weeks on the study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 256
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 (32)
Stanford CRS
🇺🇸Palo Alto, California, United States
Santa Clara Valley Med. Ctr.
🇺🇸San Jose, California, United States
San Mateo County AIDS Program
🇺🇸San Mateo, California, United States
St. Louis ConnectCare, Infectious Diseases Clinic
🇺🇸Saint Louis, Missouri, United States
Washington U CRS
🇺🇸Saint Louis, Missouri, United States
SUNY - Buffalo, Erie County Medical Ctr.
🇺🇸Buffalo, New York, United States
Beth Israel Med. Ctr. (Mt. Sinai)
🇺🇸New York, New York, United States
NYU Med. Ctr., Dept. of Medicine
🇺🇸New York, New York, United States
Univ. of Rochester ACTG CRS
🇺🇸Rochester, New York, United States
Carolinas HealthCare System, Carolinas Med. Ctr.
🇺🇸Charlotte, North Carolina, United States
Puerto Rico-AIDS CRS
🇵🇷San Juan, Puerto Rico
The Ohio State University Medical Center
🇺🇸Columbus, Ohio, United States
UCLA CARE Center CRS
🇺🇸Los Angeles, California, United States
Cook County Hosp. CORE Ctr.
🇺🇸Chicago, Illinois, United States
Rush Univ. Med. Ctr. ACTG CRS
🇺🇸Chicago, Illinois, United States
Weiss Memorial Hosp.
🇺🇸Chicago, Illinois, United States
Northwestern University CRS
🇺🇸Chicago, Illinois, United States
Johns Hopkins Adult AIDS CRS
🇺🇸Baltimore, Maryland, United States
Beth Israel Deaconess Med. Ctr., ACTG CRS
🇺🇸Boston, Massachusetts, United States
Regional Center for Infectious Disease, Wendover Medical Center CRS
🇺🇸Greensboro, North Carolina, United States
MetroHealth CRS
🇺🇸Cleveland, Ohio, United States
Hosp. of the Univ. of Pennsylvania CRS
🇺🇸Philadelphia, Pennsylvania, United States
University of Washington AIDS CRS
🇺🇸Seattle, Washington, United States
Queens Med. Ctr.
🇺🇸Honolulu, Hawaii, United States
Univ. of Hawaii at Manoa, Leahi Hosp.
🇺🇸Honolulu, Hawaii, United States
Alabama Therapeutics CRS
🇺🇸Birmingham, Alabama, United States
Ucsd, Avrc Crs
🇺🇸San Diego, California, United States
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
🇺🇸Indianapolis, Indiana, United States
Univ. of Miami AIDS CRS
🇺🇸Miami, Florida, United States
Methodist Hosp. of Indiana
🇺🇸Indianapolis, Indiana, United States
University of Colorado Hospital CRS
🇺🇸Aurora, Colorado, United States
Unc Aids Crs
🇺🇸Chapel Hill, North Carolina, United States