A Comparison of Lamivudine and Zidovudine, Used Alone and Together, in HIV-Infected Patients Who Have Not Used Zidovudine in the Past
- Conditions
- HIV Infections
- Registration Number
- NCT00002320
- Lead Sponsor
- Glaxo Wellcome
- Brief Summary
To evaluate the safety and efficacy of high-dose lamivudine (3TC) alone versus zidovudine (AZT) alone versus 3TC at high and low doses in combination with AZT in HIV-1 infected patients.
PER 02/27/95 AMENDMENT: To evaluate the efficacy and safety of both blinded and open-label combination therapy.
- Detailed Description
Patients are randomized to one of four treatment arms: 3TC alone, AZT alone, low-dose 3TC plus AZT, or high-dose 3TC plus AZT. Patients receive treatment for 32 weeks, with possible extension to 52 weeks.
PER 02/27/95 AMENDMENT: Patients may continue therapy on AZT and low-dose 3TC on an open-label basis. Open-label therapy continues with follow-up every 8 weeks until intolerable toxicity occurs or study terminates.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 320
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 (22)
AIDS Research Consortium of Atlanta
🇺🇸Atlanta, Georgia, United States
Chicago Ctr for Clinical Research
🇺🇸Chicago, Illinois, United States
Nicholaos Bellos
🇺🇸Dallas, Texas, United States
Infectious Disease Research Institute Inc
🇺🇸Tampa, Florida, United States
CRI of New England
🇺🇸Brookline, Massachusetts, United States
Central Texas Med Foundation
🇺🇸Austin, Texas, United States
Combat Group
🇺🇸Los Angeles, California, United States
Pacific Oaks Med Group
🇺🇸Sherman Oaks, California, United States
Harbor - UCLA Med Ctr
🇺🇸Torrance, California, United States
Med College of Ohio
🇺🇸Toledo, Ohio, United States
Richmond AIDS Consortium
🇺🇸Richmond, Virginia, United States
Portland Veterans Adm Med Ctr / Rsch & Education Grp
🇺🇸Portland, Oregon, United States
San Diego Community Research Group
🇺🇸San Diego, California, United States
Ottawa General Hospital
🇨🇦Ottawa, Ontario, Canada
Saint Luke's - Roosevelt Hosp Ctr
🇺🇸New York, New York, United States
Louisiana Cardiovascular Research Ctr
🇺🇸New Orleans, Louisiana, United States
Univ of North Carolina School of Medicine
🇺🇸Chapel Hill, North Carolina, United States
Mem Hosp of Rhode Island
🇺🇸Pawtucket, Rhode Island, United States
Advance Community Health Services Inc
🇵🇷Santurce, Puerto Rico
Toronto Hosp
🇨🇦Toronto, Ontario, Canada
Wisconsin Community - Based Research Consortium
🇺🇸Milwaukee, Wisconsin, United States
Montreal Gen Hosp
🇨🇦Montreal, Quebec, Canada