A Randomized, Parallel Arm, Comparative, Open Label, Multicenter Study of the Activity and Safety of Two Formulations of Saquinavir in Combination With Other Antiretroviral Drugs
- Conditions
- HIV Infections
- Registration Number
- NCT00002162
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
To evaluate the antiviral activity and safety of two formulations of saquinavir in combination with licensed nucleoside antiretroviral drugs.
- Detailed Description
Patients are randomized to receive either hard gel or soft gel capsules of saquinavir in combination with at least one licensed nucleoside antiretroviral. Treatment will continue for 48 weeks. After the first 16 weeks, patients will be given the opportunity to roll over to the saquinavir formulation of choice.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 140
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 (27)
UCD Med Ctr
🇺🇸Sacramento, California, United States
Rush Presbyterian - Saint Luke's Med Ctr
🇺🇸Chicago, Illinois, United States
UCSD Treatment Ctr
🇺🇸San Diego, California, United States
Mount Zion Hosp of UCSF
🇺🇸San Francisco, California, United States
San Francisco Veterans Adm Med Cntr
🇺🇸San Francisco, California, United States
Whitman Walker Clinic
🇺🇸Washington, District of Columbia, United States
Saint Joseph's Hosp
🇺🇸Tampa, Florida, United States
Cook County Hosp
🇺🇸Chicago, Illinois, United States
Tulane Univ / Tulane / LSU Clinical Trials Unit
🇺🇸New Orleans, Louisiana, United States
New England Med Ctr
🇺🇸Boston, Massachusetts, United States
Harvard Univ / Massachusetts Gen Hosp
🇺🇸Boston, Massachusetts, United States
Infectious Diseases Association of Houston
🇺🇸Houston, Texas, United States
Univ of Oklahoma
🇺🇸Oklahoma City, Oklahoma, United States
Beth Israel Med Ctr
🇺🇸New York, New York, United States
Univ of Colorado Health Sciences Ctr
🇺🇸Denver, Colorado, United States
Miami Veterans Administration Med Ctr
🇺🇸Miami, Florida, United States
St Vincents Hosp and Med Ctr / AIDS Cntr Progrm
🇺🇸New York, New York, United States
Univ of Pennsylvania / Division of Infectious Disease
🇺🇸Philadelphia, Pennsylvania, United States
Univ of Texas Med Branch
🇺🇸Galveston, Texas, United States
Southern Alberta HIV Clinic / Foot Hills Hosp
🇨🇦Calgary, Alberta, Canada
McMaster Univ Med Ctr
🇨🇦Hamilton, Ontario, Canada
Montreal Gen Hosp / Div of Clin Immuno and Allergy
🇨🇦Montreal, Quebec, Canada
AIDS Research Ctr
🇺🇸Palo Alto, California, United States
AIDS Research Consortium of Atlanta
🇺🇸Atlanta, Georgia, United States
Phoenix Body Positive
🇺🇸Phoenix, Arizona, United States
UCLA AIDS Clinical Research Ctr / Dept of Medicine
🇺🇸Los Angeles, California, United States
Saint Paul's Hosp / Canadian HIV Trials Network
🇨🇦Vancouver, British Columbia, Canada