A Study of Zidovudine (AZT) Used Alone or in Combination With Other Anti-HIV Drugs in HIV-Infected Patients With Little or No Previous Treatment
- Conditions
- HIV Infections
- Registration Number
- NCT00002334
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
To compare, in zidovudine (AZT)-naive patients, the safety, tolerance, and efficacy of saquinavir mesylate (Ro 31-8959) alone versus AZT alone versus AZT in combination with Ro 31-8959, zalcitabine (ddC), or both. To compare various disease markers among the different regimens.
- Detailed Description
Patients are randomized to receive a minimum of 80 weeks of AZT alone, AZT plus ddC, AZT plus Ro 31-8959, or all three drugs.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3000
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 (25)
N Texas Ctr for AIDS & Clin Rsch
🇺🇸Dallas, Texas, United States
Cook County Hosp
🇺🇸Chicago, Illinois, United States
Respiratory Associates
🇺🇸Corpus Christi, Texas, United States
Univ TX Galveston Med Branch
🇺🇸Galveston, Texas, United States
Massachusetts Gen Hosp
🇺🇸Boston, Massachusetts, United States
Univ Hosp of Cleveland / Case Western Reserve Univ
🇺🇸Cleveland, Ohio, United States
HIV Wellness Ctr / Univ Med Ctr
🇺🇸Las Vegas, Nevada, United States
Davies Med Ctr
🇺🇸San Francisco, California, United States
Mount Zion Med Ctr / UCSF
🇺🇸San Francisco, California, United States
Univ of Miami School of Medicine
🇺🇸Miami, Florida, United States
Univ of Washington
🇺🇸Seattle, Washington, United States
Thomas Street Clinic / Baylor College of Medicine
🇺🇸Houston, Texas, United States
San Juan Veterans Administration Med Ctr
🇵🇷San Juan, Puerto Rico
Howard Univ
🇺🇸Washington, District of Columbia, United States
UCD Med Ctr
🇺🇸Sacramento, California, United States
Phoenix Body Positive
🇺🇸Phoenix, Arizona, United States
Sunnyvale Med Clinic
🇺🇸Sunnyvale, California, United States
Pacific Oaks Med Group
🇺🇸Sherman Oaks, California, United States
Novum Inc
🇺🇸Pittsburgh, Pennsylvania, United States
Miami Veterans Administration Med Ctr
🇺🇸Miami, Florida, United States
Rush Presbyterian - Saint Luke's Med Ctr
🇺🇸Chicago, Illinois, United States
Tulane Univ Med School
🇺🇸New Orleans, Louisiana, United States
Beth Israel Med Ctr
🇺🇸New York, New York, United States
Harkness Pavilion
🇺🇸New York, New York, United States
Univ of Oklahoma Health Science / Pharmacy Practice
🇺🇸Oklahoma City, Oklahoma, United States