A Comparison of Three Anti-HIV Drug Combinations Containing Saquinavir Soft Gelatin Capsules Used in HIV-1 Infected Patients

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002378
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: December 1998
  Purpose

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.


Condition Intervention Phase
HIV Infections
Drug: Ritonavir
Drug: Nelfinavir mesylate
Drug: Saquinavir
Drug: Delavirdine mesylate
Drug: Lamivudine
Drug: Stavudine
Drug: Zidovudine
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment: 825
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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002378

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Locations
United States, Alabama
ASC Inc
Aniston, Alabama, United States, 36201
United States, Arizona
CIGNA
Phoenix, Arizona, United States, 85006
Arizona Clinical Research Ctr Inc
Tucson, Arizona, United States, 85712
Univ of Arizona
Tucson, Arizona, United States, 85724
United States, California
Alta Bates Med Ctr
Berkeley, California, United States, 94705
Ctr for Special Immunology
Irving, California, United States, 92718
Beer Med Group
Los Angeles, California, United States, 90036
AIDS Healthcare Foundation Labs
Los Angeles, California, United States, 90027
Dr Charles Farthing
Los Angeles, California, United States, 90048
Gottlieb Med Group
North Hollywood, California, United States, 91607
Dr Wilbert Jordan
Paramount, California, United States, 90723
AIDS Community Research Consortium
Redwood City, California, United States, 94063
UCSF - San Francisco Gen Hosp
San Francisco, California, United States, 94110
Kaiser Permanente Med Ctr
San Francisco, California, United States, 94115
Dr Daniel Pearce
San Francisco, California, United States, 92101
QUEST Clinical Research
San Francisco, California, United States, 94115
Marin County Specialty Clinic
San Rafael, California, United States, 94903
Shared Med Research Foundation
Tarzana, California, United States, 91356
United States, Colorado
Denver Public Health Dept / Disease Control Services
Denver, Colorado, United States, 80204
Kaiser Permanente, Infectious Disease
Denver, Colorado, United States, 80205
United States, District of Columbia
Georgetown Univ Med Ctr
Washington, District of Columbia, United States, 20007
Anderson Clinical Research
Washington, District of Columbia, United States, 20037
Providence Hosp
Washington, District of Columbia, United States, 20037
United States, Florida
IDC Research Initiative
Altamonte Springs, Florida, United States, 32701
Stratogen of Ft Lauderdale
Fort Lauderdale, Florida, United States, 33334
Urgent Care Ctr
Fort Lauderdale, Florida, United States, 33316
Dr Robert Schwartz
Fort Myers, Florida, United States, 33901
Duval County Health Dept
Jacksonville, Florida, United States, 32206
Steinhart Medical Associates
Miami, Florida, United States, 33133
Stratogen Health of Palm Beach
Palm Beach Gardens, Florida, United States, 33410
Ctr for Quality Care
Tampa, Florida, United States, 33609
Univ of South Florida
Tampa, Florida, United States, 33612
Infectious Disease Research Institute Inc
Tampa, Florida, United States, 33614
Treasure Coast Infectious Disease Consultants
Vero Beach, Florida, United States, 32960
United States, Georgia
AIDS Research Consortium of Atlanta
Atlanta, Georgia, United States, 30308
Infectious Disease Specialists of Atlanta
Decatur, Georgia, United States, 30033
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Northwestern Univ Med Ctr
Chicago, Illinois, United States, 60611
SIU School of Medicine
Springfield, Illinois, United States, 62702
Carle Clinic Association
Urbana, Illinois, United States, 61801
United States, Indiana
Indiana Univ Hosp
Indianapolis, Indiana, United States, 462025250
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Univ of Kentucky / Kentucky Clinic Annex #
Lexington, Kentucky, United States, 40536
United States, Massachusetts
Community Research Initiative
Brookline, Massachusetts, United States, 02445
Univ of Massachusetts Med Ctr
Worcester, Massachusetts, United States, 01655
United States, Michigan
Harper Hosp
Detroit, Michigan, United States, 48201
Saint Joseph's / Mercy Hosp
Ypsilanti, Michigan, United States, 48197
United States, Minnesota
Abbott Northwestern Hosp
Minneapolis, Minnesota, United States, 55407
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Missouri
Univ of Missouri at Kansas City School of Medicine
Kansas City, Missouri, United States, 64108
Antibiotic Research Associates
Kansas City, Missouri, United States, 64132
United States, Nevada
HIV Wellness Ctr / Univ Med Ctr
Las Vegas, Nevada, United States, 89102
United States, New Hampshire
Dartmouth-Hitchcock Med Ctr
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
UMDNJ - New Jersey Med School / Cooper Hosp
Camden, New Jersey, United States, 08103
VAMC New Jersey Healthcare System
East Orange, New Jersey, United States, 07018
New Jersey Community Research Initiative
Newark, New Jersey, United States, 07103
St Joseph's Hosp & Med Center
Paterson, New Jersey, United States, 07503
United States, New York
Albany Med College / Division of HIV Medicine A158
Albany, New York, United States, 122083479
Montefiore Med Ctr
Bronx, New York, United States, 10467
Brookdale Univ Med Ctr
Brooklyn, New York, United States, 11212
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Nassau County Med Ctr
East Meadow, New York, United States, 11554
Elmhurst Hosp
Elmhurst, New York, United States, 11373
North Shore Univ Hosp
Manhasset, New York, United States, 11030
Mt Vernon Hosp
Mt. Vernon, New York, United States, 10550
Dr Douglas Dieterich
New York, New York, United States, 10016
Harlem Hosp Ctr
New York, New York, United States, 10037
New York Hosp - Cornell Med Ctr
New York, New York, United States, 10021
Dr Ron Grossman
New York, New York, United States, 10016
AIDS Clinical Trials Unit
New York, New York, United States, 10016
New York Hosp / Cornell Med Ctr
New York, New York, United States, 10021
Liberty Med Group
New York, New York, United States, 10016
Howard Grossman
New York, New York, United States, 10011
Peter Krueger Clinic
New York, New York, United States, 10003
Dr Michael Mullen
New York, New York, United States, 10003
New York / Cornell Med Ctr
New York, New York, United States, 10021
St Lukes / Roosevelt Hosp / HIV Center
New York, New York, United States, 10019
United States, North Carolina
Nalle Clinic
Charlotte, North Carolina, United States, 28207
Carolinas Research Associates
Charlotte, North Carolina, United States, 28203
East Carolina Univ School of Medicine
Greenville, North Carolina, United States, 27858
Bowman Gray School of Medicine
Winston Salem, North Carolina, United States, 27157
United States, Ohio
Univ of Cincinnati Med Ctr / Holmes Division
Cincinnati, Ohio, United States, 45267
United States, Oklahoma
Oklahoma Univ Health Science Ctr
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Lehigh Valley Hosp
Allentown, Pennsylvania, United States, 18105
Allegheny Univ Hosp
Philadelphia, Pennsylvania, United States, 19129
Dr Jay Kostman
Philadelphia, Pennsylvania, United States, 19140
United States, Rhode Island
Roger Williams Med Ctr
Providence, Rhode Island, United States, 02908
United States, South Carolina
Burnside Clinic
Columbia, South Carolina, United States, 29206
United States, Texas
Austin Infectious Disease Consultants
Austin, Texas, United States, 78705
Dr Nicholaos Bellos
Dallas, Texas, United States, 75225
Univ of Texas Southwestern Med Ctr of Dallas
Dallas, Texas, United States, 75235
North Texas Infectious Disease Consultants
Dallas, Texas, United States, 75246
ONCOL Med Associates / PA
Houston, Texas, United States, 77027
Houston Clinical Research Network
Houston, Texas, United States, 77004
Houston Med Ctr
Houston, Texas, United States, 77030
Houston Clinical Research Network
Houston, Texas, United States, 77098
United States, Virginia
Infectious Disease Physicians Inc
Annandale, Virginia, United States, 22203
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Swedish Med Ctr / Dr Peter Shalit
Seattle, Washington, United States, 98104
United States, Wisconsin
Aurora Med Group
Milwaukee, Wisconsin, United States, 53212
Germany
Medizinische Einrichtungen der Heinrich U
Duesseldorf, Germany
Italy
Ospedale S Raffaele
Milano, Italy
Puerto Rico
San Juan Veterans Administration Med Ctr
San Juan, Puerto Rico, 009275800
Spain
Hosp Valle D Hebron
Barcelona, Spain
United Kingdom
Royal Liverpool Univ Hosp
Liverpool, United Kingdom
Sponsors and Collaborators
Hoffmann-La Roche
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00002378     History of Changes
Other Study ID Numbers: 229H, NR15520, M6101
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
HIV-1
Drug Therapy, Combination
Zidovudine
Stavudine
HIV Protease Inhibitors
Lamivudine
RNA, Viral
Dosage Forms
Saquinavir
Reverse Transcriptase Inhibitors
Anti-HIV Agents
Viral Load
Nelfinavir

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Zidovudine
Stavudine
Lamivudine
Reverse Transcriptase Inhibitors
Delavirdine
Saquinavir
Ritonavir
Nelfinavir
HIV Protease Inhibitors
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on August 01, 2014