A Comparison of Three Anti-HIV Drug Combinations Containing Saquinavir Soft Gelatin Capsules Used in HIV-1 Infected Patients
- Conditions
- HIV Infections
- Registration Number
- NCT00002378
- Lead Sponsor
- Hoffmann-La Roche
- 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.
- Detailed Description
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 treatment naive and 50% will be NRTI experienced.) Further, patients are randomized with stratification based on HIV-1 RNA level (5,000-30,000 copies/ml vs. greater than 30,000 copies/ml) and prior antiretroviral therapy to one of the three study arms.
The drug regimens for the three treatment arms are as follows:
ARM A: Fortovase (FTV), plus 2 new NRTIs\*. ARM B: FTV plus 2 new NRTIs\*. ARM C: FTV plus nelfinavir plus new NRTI\*\*.
* Naive patients in Arm A and Arm B will take: d4T (or zidovudine) plus 3TC unless contraindicated.
\*\* Naive patients in Arm C will take: d4T, unless contraindicated.
* NRTI experienced patients in Arms A \& B should be treated with 2 NRTIs to which he/she has not been previously exposed. If the patient has only 1 NRTI to which he/she has never been exposed, then the second NRTI can be one that the patient has been previously exposed to from the most distant past.
Therapy is administered for an initial 24 weeks and may be extended for an additional 24 weeks.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 825
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 (101)
Northwestern Univ Med Ctr
🇺🇸Chicago, Illinois, United States
Lehigh Valley Hosp
🇺🇸Allentown, Pennsylvania, United States
North Texas Infectious Disease Consultants
🇺🇸Dallas, Texas, United States
Dr Daniel Pearce
🇺🇸San Francisco, California, United States
Steinhart Medical Associates
🇺🇸Miami, Florida, United States
UCSF - San Francisco Gen Hosp
🇺🇸San Francisco, California, United States
Kaiser Permanente Med Ctr
🇺🇸San Francisco, California, United States
Abbott Northwestern Hosp
🇺🇸Minneapolis, Minnesota, United States
HIV Wellness Ctr / Univ Med Ctr
🇺🇸Las Vegas, Nevada, United States
ONCOL Med Associates / PA
🇺🇸Houston, Texas, United States
Houston Med Ctr
🇺🇸Houston, Texas, United States
CIGNA
🇺🇸Phoenix, Arizona, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Oklahoma Univ Health Science Ctr
🇺🇸Oklahoma City, Oklahoma, United States
Ctr for Quality Care
🇺🇸Tampa, Florida, United States
Infectious Disease Research Institute Inc
🇺🇸Tampa, Florida, United States
AIDS Community Research Consortium
🇺🇸Redwood City, California, United States
Dr Wilbert Jordan
🇺🇸Paramount, California, United States
Shared Med Research Foundation
🇺🇸Tarzana, California, United States
Roger Williams Med Ctr
🇺🇸Providence, Rhode Island, United States
AIDS Healthcare Foundation Labs
🇺🇸Los Angeles, California, United States
Beer Med Group
🇺🇸Los Angeles, California, United States
Denver Public Health Dept / Disease Control Services
🇺🇸Denver, Colorado, United States
Univ of Arizona
🇺🇸Tucson, Arizona, United States
Alta Bates Med Ctr
🇺🇸Berkeley, California, United States
Dr Charles Farthing
🇺🇸Los Angeles, California, United States
ASC Inc
🇺🇸Aniston, Alabama, United States
IDC Research Initiative
🇺🇸Altamonte Springs, Florida, United States
Univ of Cincinnati Med Ctr / Holmes Division
🇺🇸Cincinnati, Ohio, United States
Gottlieb Med Group
🇺🇸North Hollywood, California, United States
Univ of Texas Southwestern Med Ctr of Dallas
🇺🇸Dallas, Texas, United States
San Juan Veterans Administration Med Ctr
🇵🇷San Juan, Puerto Rico
Medizinische Einrichtungen der Heinrich U
🇩🇪Duesseldorf, Germany
Marin County Specialty Clinic
🇺🇸San Rafael, California, United States
Duval County Health Dept
🇺🇸Jacksonville, Florida, United States
Arizona Clinical Research Ctr Inc
🇺🇸Tucson, Arizona, United States
Ctr for Special Immunology
🇺🇸Irving, California, United States
Providence Hosp
🇺🇸Washington, District of Columbia, United States
Georgetown Univ Med Ctr
🇺🇸Washington, District of Columbia, United States
Kaiser Permanente, Infectious Disease
🇺🇸Denver, Colorado, United States
Anderson Clinical Research
🇺🇸Washington, District of Columbia, United States
QUEST Clinical Research
🇺🇸San Francisco, California, United States
Stratogen of Ft Lauderdale
🇺🇸Fort Lauderdale, Florida, United States
Urgent Care Ctr
🇺🇸Fort Lauderdale, Florida, United States
Dr Robert Schwartz
🇺🇸Fort Myers, Florida, United States
Univ of South Florida
🇺🇸Tampa, Florida, United States
Stratogen Health of Palm Beach
🇺🇸Palm Beach Gardens, Florida, United States
AIDS Research Consortium of Atlanta
🇺🇸Atlanta, Georgia, United States
Treasure Coast Infectious Disease Consultants
🇺🇸Vero Beach, Florida, United States
Infectious Disease Specialists of Atlanta
🇺🇸Decatur, Georgia, United States
SIU School of Medicine
🇺🇸Springfield, Illinois, United States
Univ of Kentucky / Kentucky Clinic Annex #
🇺🇸Lexington, Kentucky, United States
Harper Hosp
🇺🇸Detroit, Michigan, United States
Carle Clinic Association
🇺🇸Urbana, Illinois, United States
Indiana Univ Hosp
🇺🇸Indianapolis, Indiana, United States
Univ of Massachusetts Med Ctr
🇺🇸Worcester, Massachusetts, United States
Saint Joseph's / Mercy Hosp
🇺🇸Ypsilanti, Michigan, United States
Univ of Missouri at Kansas City School of Medicine
🇺🇸Kansas City, Missouri, United States
Community Research Initiative
🇺🇸Brookline, Massachusetts, United States
Antibiotic Research Associates
🇺🇸Kansas City, Missouri, United States
Dartmouth-Hitchcock Med Ctr
🇺🇸Lebanon, New Hampshire, United States
New Jersey Community Research Initiative
🇺🇸Newark, New Jersey, United States
UMDNJ - New Jersey Med School / Cooper Hosp
🇺🇸Camden, New Jersey, United States
VAMC New Jersey Healthcare System
🇺🇸East Orange, New Jersey, United States
St Joseph's Hosp & Med Center
🇺🇸Paterson, New Jersey, United States
Montefiore Med Ctr
🇺🇸Bronx, New York, United States
Albany Med College / Division of HIV Medicine A158
🇺🇸Albany, New York, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Nassau County Med Ctr
🇺🇸East Meadow, New York, United States
Elmhurst Hosp
🇺🇸Elmhurst, New York, United States
Brookdale Univ Med Ctr
🇺🇸Brooklyn, New York, United States
Dr Michael Mullen
🇺🇸New York, New York, United States
Dr Douglas Dieterich
🇺🇸New York, New York, United States
North Shore Univ Hosp
🇺🇸Manhasset, New York, United States
Peter Krueger Clinic
🇺🇸New York, New York, United States
AIDS Clinical Trials Unit
🇺🇸New York, New York, United States
Mt Vernon Hosp
🇺🇸Mt. Vernon, New York, United States
Howard Grossman
🇺🇸New York, New York, United States
New York Hosp - Cornell Med Ctr
🇺🇸New York, New York, United States
Dr Ron Grossman
🇺🇸New York, New York, United States
Liberty Med Group
🇺🇸New York, New York, United States
New York / Cornell Med Ctr
🇺🇸New York, New York, United States
St Lukes / Roosevelt Hosp / HIV Center
🇺🇸New York, New York, United States
New York Hosp / Cornell Med Ctr
🇺🇸New York, New York, United States
East Carolina Univ School of Medicine
🇺🇸Greenville, North Carolina, United States
Harlem Hosp Ctr
🇺🇸New York, New York, United States
Carolinas Research Associates
🇺🇸Charlotte, North Carolina, United States
Nalle Clinic
🇺🇸Charlotte, North Carolina, United States
Bowman Gray School of Medicine
🇺🇸Winston Salem, North Carolina, United States
Allegheny Univ Hosp
🇺🇸Philadelphia, Pennsylvania, United States
Burnside Clinic
🇺🇸Columbia, South Carolina, United States
Dr Jay Kostman
🇺🇸Philadelphia, Pennsylvania, United States
Austin Infectious Disease Consultants
🇺🇸Austin, Texas, United States
Dr Nicholaos Bellos
🇺🇸Dallas, Texas, United States
Houston Clinical Research Network
🇺🇸Houston, Texas, United States
Infectious Disease Physicians Inc
🇺🇸Annandale, Virginia, United States
Aurora Med Group
🇺🇸Milwaukee, Wisconsin, United States
Swedish Med Ctr / Dr Peter Shalit
🇺🇸Seattle, Washington, United States
Ospedale S Raffaele
🇮🇹Milano, Italy
Royal Liverpool Univ Hosp
🇬🇧Liverpool, United Kingdom
Hosp Valle D Hebron
🇪🇸Barcelona, Spain