The Safety and Effectiveness of Three Anti-HIV Drug Combinations in HIV-Infected Patients Who Have Taken AZT
- Conditions
- HIV Infections
- Registration Number
- NCT00002436
- Lead Sponsor
- Glaxo Wellcome
- Brief Summary
To evaluate the safety and efficacy of low and high doses of lamivudine ( 3TC ) in combination with zidovudine ( AZT ) and zalcitabine ( dideoxycytidine; ddC ) in combination with AZT.
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 three treatment arms: low-dose 3TC plus AZT, high-dose 3TC plus AZT, or ddC plus AZT. Treatment continues 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
- 325
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)
Combat Group
🇺🇸Los Angeles, California, United States
San Diego Community Research Group
🇺🇸San Diego, California, United States
ViRx Inc
🇺🇸San Francisco, California, United States
AIDS Research Consortium of Atlanta
🇺🇸Atlanta, Georgia, United States
Chicago Ctr for Clinical Research
🇺🇸Chicago, Illinois, United States
Louisiana Cardiovascular Research Ctr
🇺🇸New Orleans, Louisiana, United States
Boston City Hosp / FGH-1
🇺🇸Boston, Massachusetts, United States
Nassau County Med Ctr
🇺🇸East Meadow, New York, United States
Saint Luke's - Roosevelt Hosp Ctr
🇺🇸New York, New York, United States
Nalle Clinic
🇺🇸Charlotte, North Carolina, United States
Scroll for more (12 remaining)Combat Group🇺🇸Los Angeles, California, United States