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)
Univ of Miami Dept of Medicine
🇺🇸Miami, Florida, United States
Sunnyvale Med Clinic
🇺🇸Sunnyvale, California, United States
Rush Presbyterian - Saint Luke's Med Ctr
🇺🇸Chicago, Illinois, United States
Davies Med Ctr / c/o HIV Institute
🇺🇸San Francisco, California, United States
Mount Zion Med Ctr / UCSF
🇺🇸San Francisco, California, United States
UCSF - San Francisco Gen Hosp
🇺🇸San Francisco, California, United States
San Francisco Veterans Administration Med Ctr
🇺🇸San Francisco, California, United States
Clinique Medicale L'Actuele
🇨🇦Montreal, Quebec, Canada
Harper Hosp
🇺🇸Detroit, Michigan, United States
Sunnybrook Health Science Ctr
🇨🇦Toronto, Ontario, Canada
New England Med Ctr
🇺🇸Boston, Massachusetts, United States
Massachusetts Gen Hosp / Harvard Med School
🇺🇸Boston, Massachusetts, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Montreal Gen Hosp
🇨🇦Montreal, Quebec, Canada
New England Deaconess Hosp
🇺🇸Boston, Massachusetts, United States
CARE Ctr / UCLA Med Ctr
🇺🇸Los Angeles, California, United States
Veterans Administration Med Ctr
🇺🇸Washington, District of Columbia, United States
UCD
🇺🇸Sacramento, California, United States
Harbor - UCLA Med Ctr
🇺🇸Torrance, California, United States
AIDS Research Consortium of Atlanta
🇺🇸Atlanta, Georgia, United States
Univ of Kansas School of Medicine
🇺🇸Wichita, Kansas, United States
Stratogen of South Florida
🇺🇸Miami Beach, Florida, United States
Tulane Univ Med School
🇺🇸New Orleans, Louisiana, United States
West Paces Clinical Research Incoporated
🇺🇸Atlanta, Georgia, United States
Kaiser Foundation Hosp
🇺🇸Harbor City, California, United States
UCLA School of Medicine
🇺🇸Los Angeles, California, United States
UCSD
🇺🇸La Jolla, California, United States
Pacific Oaks Med Group / Rsch & Scientific Investigation
🇺🇸Sherman Oaks, California, United States
Miami Veterans Administration Med Ctr
🇺🇸Miami, Florida, United States
Washington Univ School of Medicine
🇺🇸St. Louis, Missouri, United States
UMDNJ - New Jersy Med School
🇺🇸Newark, New Jersey, United States
UMDNJ - New Jersey Med School / Cooper Hosp
🇺🇸Camden, New Jersey, United States
Beth Israel Med Ctr
🇺🇸New York, New York, United States
Albany Med College
🇺🇸Albany, New York, United States
Thomas Jefferson Med College
🇺🇸Philadelphia, Pennsylvania, United States
Ohio State Univ Hosp
🇺🇸Columbus, Ohio, United States
Saint Vincent's Hosp and Med Ctr
🇺🇸New York, New York, United States
Harkness Pavilion
🇺🇸New York, New York, United States
Oregon Health Sciences Univ
🇺🇸Portland, Oregon, United States
Graduate Hosp / Tuttleman Cancer Ctr
🇺🇸Philadelphia, Pennsylvania, United States
Univ TX Galveston Med Branch
🇺🇸Galveston, Texas, United States
Univ of Tennessee
🇺🇸Memphis, Tennessee, United States
Southern Alberta HIV Clinic
🇨🇦Calgary, Alberta, Canada
Oaklawn Physicians Group
🇺🇸Dallas, Texas, United States
Univ of Washington / Harborview Med Ctr
🇺🇸Seattle, Washington, United States
McMaster Univ Med Ctr
🇨🇦Hamilton, Ontario, Canada
San Juan Veterans Administration Med Ctr
🇵🇷San Juan, Puerto Rico