A Study of Saquinavir and Zalcitabine, Used Alone and Together, in the Treatment of Advanced HIV Infection in Patients Who Stopped Taking or Who Cannot Take Zidovudine
- Conditions
- HIV Infections
- Registration Number
- NCT00002333
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
To compare the safety, tolerance, and efficacy of saquinavir mesylate (Ro 31-8959) alone, zalcitabine (dideoxycytidine; ddC) alone, and both in combination, in patients discontinuing or unable to take zidovudine (AZT).
- Detailed Description
Patients are randomized to one of three treatment regimens: ddC alone, Ro 31-8959 alone, and ddC plus Ro 31-8959. Treatment continues for at least 48 weeks. Patients are stratified by baseline CD4 count. (Per 09/26/94 amendment, a fourth arm, lower dose Ro 31-8959 plus ddC, was discontinued.)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 900
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 (47)
Kaiser Foundation Hosp
🇺🇸Harbor City, California, United States
UCSD
🇺🇸La Jolla, California, United States
UCLA School of Medicine
🇺🇸Los Angeles, California, United States
CARE Ctr / UCLA Med Ctr
🇺🇸Los Angeles, California, United States
UCD
🇺🇸Sacramento, California, United States
UCSF - San Francisco Gen Hosp
🇺🇸San Francisco, California, United States
Davies Med Ctr / c/o HIV Institute
🇺🇸San Francisco, California, United States
Mount Zion Med Ctr / UCSF
🇺🇸San Francisco, California, United States
San Francisco Veterans Administration Med Ctr
🇺🇸San Francisco, California, United States
Pacific Oaks Med Group / Rsch & Scientific Investigation
🇺🇸Sherman Oaks, California, United States
Scroll for more (37 remaining)Kaiser Foundation Hosp🇺🇸Harbor City, California, United States