A Comparison of Three Anti-HIV Drug Combinations Containing Saquinavir Soft Gelatin Capsules Used in HIV-1 Infected Patients
Launched by HOFFMANN-LA ROCHE · Aug 30, 2001
Trial Information
Current as of March 23, 2025
Completed
Keywords
ClinConnect Summary
Patients will be randomized to receive 1 of 3 study regimens: Group A - Saquinavir (SQV) sgc plus 2 new reverse transcriptase inhibitors (RTIs), Group B - SQV sgc plus delavirdine plus new RTI, and Group C - SQV sgc plus nelfinavir plus new RTI, or SQV sgc plus ritonavir plus 2 new RTIs.
NOTE: "New RTI" is defined for this study as any reverse transcriptase inhibitor to which the patient has never been exposed.
AS PER AMENDMENT 12/12/97: In this open-label, multicenter, Phase IIIB, comparative study, 825 patients are randomized to treatment arms. (NOTE: 50% of the patients will be treatme...
Gender
ALL
Eligibility criteria
- • Inclusion Criteria
- Patients must have:
- • HIV-1 infection.
- • HIV RNA \>= 5000 copies/ml by Amplicor assay.
- • Signed, informed consent from parent or legal guardian for patients less than 18 years old.
- Prior Medication:
- Required:
- (Note:
- • 50% of the patients will be treatment naive).
- • \> 3 months cumulative therapy with antiretrovirals other than non-nucleoside reverse transcriptase inhibitors and/or protease inhibitors.
- • Stable antiretroviral therapy for at least 4 weeks prior to enrollment.
- Allowed:
- • \<= 2 weeks cumulative treatment with protease inhibitors.
- AS PER AMENDMENT 12/12/97:
- Required:
- NRTI experienced patients:
- • \> 3 months cumulative therapy with antiretrovirals.
- • \<= 2 weeks cumulative previous treatment with non-nucleoside analogue reverse transcriptase inhibitors (NNRTIs).
- • \<= 2 weeks cumulative previous treatment with protease inhibitors.
- • Must have at least one NRTI (preferably two) to which he/she has not been previously exposed.
- * Stable antiretroviral therapy defined as within (+/-) 1 log HIV-1 RNA between the 2 most recent values greater than 8 weeks apart (may include screening visit) prior to study enrollment. (NOTE:
- • If patient does not have a previous HIV-1 RNA value, screening will be accepted.)
- Required:
- * Note:
- • 50% of the patients will be treatment naive and 50% will be NRTI experienced. AS PER AMENDMENT 12/12/97.
About Hoffmann La Roche
Hoffmann-La Roche, commonly known as Roche, is a global leader in biotechnology and pharmaceuticals, committed to advancing healthcare through innovative research and development. With a strong focus on oncology, immunology, infectious diseases, and central nervous system disorders, Roche leverages cutting-edge science to deliver transformative therapies and diagnostics. The company is dedicated to improving patient outcomes by conducting rigorous clinical trials and collaborating with healthcare professionals and organizations worldwide. Roche's unwavering commitment to precision medicine and personalized healthcare positions it at the forefront of the industry, driving progress in the quest for effective treatments and improved patient care.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Rochester, Minnesota, United States
New York, New York, United States
Atlanta, Georgia, United States
Worcester, Massachusetts, United States
New York, New York, United States
Washington, District Of Columbia, United States
Albany, New York, United States
East Meadow, New York, United States
Manhasset, New York, United States
San Francisco, California, United States
San Juan, , Puerto Rico
Tampa, Florida, United States
Annandale, Virginia, United States
Dallas, Texas, United States
Houston, Texas, United States
Redwood City, California, United States
Detroit, Michigan, United States
San Rafael, California, United States
Newark, New Jersey, United States
New York, New York, United States
New York, New York, United States
San Francisco, California, United States
Camden, New Jersey, United States
Tampa, Florida, United States
Denver, Colorado, United States
Providence, Rhode Island, United States
Kansas City, Missouri, United States
Charlotte, North Carolina, United States
Tarzana, California, United States
Los Angeles, California, United States
Fort Lauderdale, Florida, United States
Chicago, Illinois, United States
Austin, Texas, United States
Bronx, New York, United States
Kansas City, Missouri, United States
Washington, District Of Columbia, United States
Los Angeles, California, United States
Brookline, Massachusetts, United States
Dallas, Texas, United States
Tucson, Arizona, United States
Altamonte Springs, Florida, United States
Fort Myers, Florida, United States
Vero Beach, Florida, United States
Philadelphia, Pennsylvania, United States
San Francisco, California, United States
Tampa, Florida, United States
Brooklyn, New York, United States
Mt. Vernon, New York, United States
New York, New York, United States
New York, New York, United States
Columbia, South Carolina, United States
Greenville, North Carolina, United States
Winston Salem, North Carolina, United States
Buffalo, New York, United States
Las Vegas, Nevada, United States
Indianapolis, Indiana, United States
Minneapolis, Minnesota, United States
Cincinnati, Ohio, United States
Houston, Texas, United States
Los Angeles, California, United States
Aniston, Alabama, United States
Phoenix, Arizona, United States
Tucson, Arizona, United States
Berkeley, California, United States
Irving, California, United States
North Hollywood, California, United States
Paramount, California, United States
San Francisco, California, United States
Denver, Colorado, United States
Washington, District Of Columbia, United States
Fort Lauderdale, Florida, United States
Jacksonville, Florida, United States
Miami, Florida, United States
Palm Beach Gardens, Florida, United States
Decatur, Georgia, United States
Springfield, Illinois, United States
Urbana, Illinois, United States
Lexington, Kentucky, United States
Ypsilanti, Michigan, United States
Lebanon, New Hampshire, United States
East Orange, New Jersey, United States
Paterson, New Jersey, United States
Elmhurst, New York, United States
New York, New York, United States
New York, New York, United States
New York, New York, United States
New York, New York, United States
New York, New York, United States
New York, New York, United States
Charlotte, North Carolina, United States
Oklahoma City, Oklahoma, United States
Allentown, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Dallas, Texas, United States
Houston, Texas, United States
Seattle, Washington, United States
Milwaukee, Wisconsin, United States
Duesseldorf, , Germany
Milano, , Italy
Barcelona, , Spain
Liverpool, , United Kingdom
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Discussion 0
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