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

June 23, 2005 updated by: Hoffmann-La Roche

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

825

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

December 1, 1998

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 229H
  • NR15520
  • M6101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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