A Comparison of Three Anti-HIV Drug Combinations Containing Saquinavir Soft Gelatin Capsules Used in HIV-1 Infected Patients
A Randomized Phase IIIB Comparative Study to Evaluate Saquinavir Soft Gel Capsule (SGC) TID Regimen in Combination With Two NRTIs Versus Saquinavir Soft Gel Capsule (SGC) BID Regimen in Combination With Two NRTIs Versus Saquinavir Soft Gel Capsule (SGC) BID Plus Nelfinavir BID Plus a NRTI in HIV-1 Infected Patients
3 other identifiers
interventional
825
6 countries
102
Brief Summary
To determine the proportion of patients whose plasma HIV-1 RNA level falls below the level of detection (\< 400 copies/ml) at week 24 of study therapy. To determine the absolute change in plasma HIV-1 RNA during the 24 weeks of study treatment. To collect safety data on the treatment regimens. AS PER AMENDMENT 12/12/97: To compare the virologic response of Fortovase (FTV) (Saquinavir) Soft Gel Capsule (SGC) tid plus nucleoside reverse transcriptase inhibitors (NRTIs) versus FTV bid plus NRTIs. Further, to compare the virologic response of FTV tid plus NRTIs versus FTV bid plus Nelfinavir bid plus a NRTI with respect to: the percentage of patients whose plasma HIV-1 RNA level falls below the Amplicor assay level of detection (\< 400 copies/ml) at week 24 and week 48.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 hiv-infections
102 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
December 1, 1998
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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:
- % 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:
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (102)
ASC Inc
Anniston, Alabama, 36201, United States
CIGNA
Phoenix, Arizona, 85006, United States
Arizona Clinical Research Ctr Inc
Tucson, Arizona, 85712, United States
Univ of Arizona
Tucson, Arizona, 85724, United States
Alta Bates Med Ctr
Berkeley, California, 94705, United States
Ctr for Special Immunology
Irvington District, California, 92718, United States
AIDS Healthcare Foundation Labs
Los Angeles, California, 90027, United States
Beer Med Group
Los Angeles, California, 90036, United States
Dr Charles Farthing
Los Angeles, California, 90048, United States
Gottlieb Med Group
North Hollywood, California, 91607, United States
Dr Wilbert Jordan
Paramount, California, 90723, United States
AIDS Community Research Consortium
Redwood City, California, 94063, United States
Dr Daniel Pearce
San Francisco, California, 92101, United States
UCSF - San Francisco Gen Hosp
San Francisco, California, 94110, United States
Kaiser Permanente Med Ctr
San Francisco, California, 94115, United States
QUEST Clinical Research
San Francisco, California, 94115, United States
Marin County Specialty Clinic
San Rafael, California, 94903, United States
Shared Med Research Foundation
Tarzana, California, 91356, United States
Denver Public Health Dept / Disease Control Services
Denver, Colorado, 80204, United States
Kaiser Permanente, Infectious Disease
Denver, Colorado, 80205, United States
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, 20007, United States
Anderson Clinical Research
Washington D.C., District of Columbia, 20037, United States
Providence Hosp
Washington D.C., District of Columbia, 20037, United States
IDC Research Initiative
Altamonte Springs, Florida, 32701, United States
Urgent Care Ctr
Fort Lauderdale, Florida, 33316, United States
Stratogen of Ft Lauderdale
Fort Lauderdale, Florida, 33334, United States
Dr Robert Schwartz
Fort Myers, Florida, 33901, United States
Duval County Health Dept
Jacksonville, Florida, 32206, United States
Steinhart Medical Associates
Miami, Florida, 33133, United States
Stratogen Health of Palm Beach
Palm Beach Gardens, Florida, 33410, United States
Ctr for Quality Care
Tampa, Florida, 33609, United States
Univ of South Florida
Tampa, Florida, 33612, United States
Infectious Disease Research Institute Inc
Tampa, Florida, 33614, United States
Treasure Coast Infectious Disease Consultants
Vero Beach, Florida, 32960, United States
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 30308, United States
Infectious Disease Specialists of Atlanta
Decatur, Georgia, 30033, United States
Northwestern Univ Med Ctr
Chicago, Illinois, 60611, United States
SIU School of Medicine
Springfield, Illinois, 62702, United States
Carle Clinic Association
Urbana, Illinois, 61801, United States
Indiana Univ Hosp
Indianapolis, Indiana, 462025250, United States
Univ of Kentucky / Kentucky Clinic Annex #
Lexington, Kentucky, 40536, United States
Community Research Initiative
Brookline, Massachusetts, 02445, United States
Univ of Massachusetts Med Ctr
Worcester, Massachusetts, 01655, United States
Harper Hosp
Detroit, Michigan, 48201, United States
Saint Joseph's / Mercy Hosp
Ypsilanti, Michigan, 48197, United States
Abbott Northwestern Hosp
Minneapolis, Minnesota, 55407, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Univ of Missouri at Kansas City School of Medicine
Kansas City, Missouri, 64108, United States
Antibiotic Research Associates
Kansas City, Missouri, 64132, United States
HIV Wellness Ctr / Univ Med Ctr
Las Vegas, Nevada, 89102, United States
Dartmouth-Hitchcock Med Ctr
Lebanon, New Hampshire, 03756, United States
UMDNJ - New Jersey Med School / Cooper Hosp
Camden, New Jersey, 08103, United States
VAMC New Jersey Healthcare System
East Orange, New Jersey, 07018, United States
New Jersey Community Research Initiative
Newark, New Jersey, 07103, United States
St Joseph's Hosp & Med Center
Paterson, New Jersey, 07503, United States
Albany Med College / Division of HIV Medicine A158
Albany, New York, 122083479, United States
Brookdale Univ Med Ctr
Brooklyn, New York, 11212, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
Nassau County Med Ctr
East Meadow, New York, 11554, United States
Elmhurst Hosp
Elmhurst, New York, 11373, United States
North Shore Univ Hosp
Manhasset, New York, 11030, United States
Mt Vernon Hosp
Mount Vernon, New York, 10550, United States
Dr Michael Mullen
New York, New York, 10003, United States
Peter Krueger Clinic
New York, New York, 10003, United States
Howard Grossman
New York, New York, 10011, United States
AIDS Clinical Trials Unit
New York, New York, 10016, United States
Dr Douglas Dieterich
New York, New York, 10016, United States
Dr Ron Grossman
New York, New York, 10016, United States
Liberty Med Group
New York, New York, 10016, United States
St Lukes / Roosevelt Hosp / HIV Center
New York, New York, 10019, United States
New York / Cornell Med Ctr
New York, New York, 10021, United States
New York Hosp - Cornell Med Ctr
New York, New York, 10021, United States
New York Hosp / Cornell Med Ctr
New York, New York, 10021, United States
Harlem Hosp Ctr
New York, New York, 10037, United States
Montefiore Med Ctr
The Bronx, New York, 10467, United States
Carolinas Research Associates
Charlotte, North Carolina, 28203, United States
Nalle Clinic
Charlotte, North Carolina, 28207, United States
East Carolina Univ School of Medicine
Greenville, North Carolina, 27858, United States
Bowman Gray School of Medicine
Winston-Salem, North Carolina, 27157, United States
Univ of Cincinnati Med Ctr / Holmes Division
Cincinnati, Ohio, 45267, United States
Oklahoma Univ Health Science Ctr
Oklahoma City, Oklahoma, 73104, United States
Lehigh Valley Hosp
Allentown, Pennsylvania, 18105, United States
Allegheny Univ Hosp
Philadelphia, Pennsylvania, 19129, United States
Dr Jay Kostman
Philadelphia, Pennsylvania, 19140, United States
Roger Williams Med Ctr
Providence, Rhode Island, 02908, United States
Burnside Clinic
Columbia, South Carolina, 29206, United States
Austin Infectious Disease Consultants
Austin, Texas, 78705, United States
Dr Nicholaos Bellos
Dallas, Texas, 75225, United States
Univ of Texas Southwestern Med Ctr of Dallas
Dallas, Texas, 75235, United States
North Texas Infectious Disease Consultants
Dallas, Texas, 75246, United States
Houston Clinical Research Network
Houston, Texas, 77004, United States
ONCOL Med Associates / PA
Houston, Texas, 77027, United States
Houston Med Ctr
Houston, Texas, 77030, United States
Houston Clinical Research Network
Houston, Texas, 77098, United States
Infectious Disease Physicians Inc
Annandale, Virginia, 22203, United States
Swedish Med Ctr / Dr Peter Shalit
Seattle, Washington, 98104, United States
Aurora Med Group
Milwaukee, Wisconsin, 53212, United States
Medizinische Einrichtungen der Heinrich U
Düsseldorf, Germany
Ospedale S Raffaele
Milan, Italy
San Juan Veterans Administration Med Ctr
San Juan, 009275800, Puerto Rico
Hosp Valle D Hebron
Barcelona, Spain
Royal Liverpool Univ Hosp
Liverpool, United Kingdom