A Comparison of Three Anti-HIV Drug Combinations Containing Saquinavir Soft Gelatin Capsules Used in HIV-1 Infected Patients
NCT ID: NCT00002378
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
825 participants
INTERVENTIONAL
Brief Summary
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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
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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.
Conditions
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Study Design
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TREATMENT
Interventions
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Ritonavir
Nelfinavir mesylate
Saquinavir
Delavirdine mesylate
Lamivudine
Stavudine
Zidovudine
Eligibility Criteria
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Inclusion Criteria
* 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.
16 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Locations
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ASC Inc
Anniston, Alabama, United States
CIGNA
Phoenix, Arizona, United States
Arizona Clinical Research Ctr Inc
Tucson, Arizona, United States
Univ of Arizona
Tucson, Arizona, United States
Alta Bates Med Ctr
Berkeley, California, United States
Ctr for Special Immunology
Irvington District, California, United States
AIDS Healthcare Foundation Labs
Los Angeles, California, United States
Beer Med Group
Los Angeles, California, United States
Dr Charles Farthing
Los Angeles, California, United States
Gottlieb Med Group
North Hollywood, California, United States
Dr Wilbert Jordan
Paramount, California, United States
AIDS Community Research Consortium
Redwood City, California, United States
Dr Daniel Pearce
San Francisco, California, United States
UCSF - San Francisco Gen Hosp
San Francisco, California, United States
Kaiser Permanente Med Ctr
San Francisco, California, United States
QUEST Clinical Research
San Francisco, California, United States
Marin County Specialty Clinic
San Rafael, California, United States
Shared Med Research Foundation
Tarzana, California, United States
Denver Public Health Dept / Disease Control Services
Denver, Colorado, United States
Kaiser Permanente, Infectious Disease
Denver, Colorado, United States
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, United States
Anderson Clinical Research
Washington D.C., District of Columbia, United States
Providence Hosp
Washington D.C., District of Columbia, United States
IDC Research Initiative
Altamonte Springs, Florida, United States
Urgent Care Ctr
Fort Lauderdale, Florida, United States
Stratogen of Ft Lauderdale
Fort Lauderdale, Florida, United States
Dr Robert Schwartz
Fort Myers, Florida, United States
Duval County Health Dept
Jacksonville, Florida, United States
Steinhart Medical Associates
Miami, Florida, United States
Stratogen Health of Palm Beach
Palm Beach Gardens, Florida, United States
Ctr for Quality Care
Tampa, Florida, United States
Univ of South Florida
Tampa, Florida, United States
Infectious Disease Research Institute Inc
Tampa, Florida, United States
Treasure Coast Infectious Disease Consultants
Vero Beach, Florida, United States
AIDS Research Consortium of Atlanta
Atlanta, Georgia, United States
Infectious Disease Specialists of Atlanta
Decatur, Georgia, United States
Northwestern Univ Med Ctr
Chicago, Illinois, United States
SIU School of Medicine
Springfield, Illinois, United States
Carle Clinic Association
Urbana, Illinois, United States
Indiana Univ Hosp
Indianapolis, Indiana, United States
Univ of Kentucky / Kentucky Clinic Annex #
Lexington, Kentucky, United States
Community Research Initiative
Brookline, Massachusetts, United States
Univ of Massachusetts Med Ctr
Worcester, Massachusetts, United States
Harper Hosp
Detroit, Michigan, United States
Saint Joseph's / Mercy Hosp
Ypsilanti, Michigan, United States
Abbott Northwestern Hosp
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Univ of Missouri at Kansas City School of Medicine
Kansas City, Missouri, United States
Antibiotic Research Associates
Kansas City, Missouri, United States
HIV Wellness Ctr / Univ Med Ctr
Las Vegas, Nevada, United States
Dartmouth-Hitchcock Med Ctr
Lebanon, New Hampshire, 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
New Jersey Community Research Initiative
Newark, New Jersey, United States
St Joseph's Hosp & Med Center
Paterson, New Jersey, United States
Albany Med College / Division of HIV Medicine A158
Albany, New York, United States
Brookdale Univ Med Ctr
Brooklyn, 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
North Shore Univ Hosp
Manhasset, New York, United States
Mt Vernon Hosp
Mount Vernon, New York, United States
Dr Michael Mullen
New York, New York, United States
Peter Krueger Clinic
New York, New York, United States
Howard Grossman
New York, New York, United States
AIDS Clinical Trials Unit
New York, New York, United States
Dr Douglas Dieterich
New York, New York, United States
Dr Ron Grossman
New York, New York, United States
Liberty Med Group
New York, New York, United States
St Lukes / Roosevelt Hosp / HIV Center
New York, New York, United States
New York / Cornell Med Ctr
New York, New York, United States
New York Hosp - Cornell Med Ctr
New York, New York, United States
New York Hosp / Cornell Med Ctr
New York, New York, United States
Harlem Hosp Ctr
New York, New York, United States
Montefiore Med Ctr
The Bronx, New York, United States
Carolinas Research Associates
Charlotte, North Carolina, United States
Nalle Clinic
Charlotte, North Carolina, United States
East Carolina Univ School of Medicine
Greenville, North Carolina, United States
Bowman Gray School of Medicine
Winston-Salem, North Carolina, United States
Univ of Cincinnati Med Ctr / Holmes Division
Cincinnati, Ohio, United States
Oklahoma Univ Health Science Ctr
Oklahoma City, Oklahoma, United States
Lehigh Valley Hosp
Allentown, Pennsylvania, United States
Allegheny Univ Hosp
Philadelphia, Pennsylvania, United States
Dr Jay Kostman
Philadelphia, Pennsylvania, United States
Roger Williams Med Ctr
Providence, Rhode Island, United States
Burnside Clinic
Columbia, South Carolina, United States
Austin Infectious Disease Consultants
Austin, Texas, United States
Dr Nicholaos Bellos
Dallas, Texas, United States
Univ of Texas Southwestern Med Ctr of Dallas
Dallas, Texas, United States
North Texas Infectious Disease Consultants
Dallas, Texas, United States
Houston Clinical Research Network
Houston, Texas, United States
ONCOL Med Associates / PA
Houston, Texas, United States
Houston Med Ctr
Houston, Texas, United States
Houston Clinical Research Network
Houston, Texas, United States
Infectious Disease Physicians Inc
Annandale, Virginia, United States
Swedish Med Ctr / Dr Peter Shalit
Seattle, Washington, United States
Aurora Med Group
Milwaukee, Wisconsin, United States
Medizinische Einrichtungen der Heinrich U
Düsseldorf, , Germany
Ospedale S Raffaele
Milan, , Italy
San Juan Veterans Administration Med Ctr
San Juan, , Puerto Rico
Hosp Valle D Hebron
Barcelona, , Spain
Royal Liverpool Univ Hosp
Liverpool, , United Kingdom
Countries
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Other Identifiers
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NR15520
Identifier Type: -
Identifier Source: secondary_id
M6101
Identifier Type: -
Identifier Source: secondary_id
229H
Identifier Type: -
Identifier Source: org_study_id