Safety and Effectiveness of Adding Saquinavir (FORTOVASE) in Soft Gel Capsule Form to an Anti-HIV Drug Combination in HIV-Infected Patients

June 23, 2005 updated by: Hoffmann-La Roche

A Phase IV, Non-Comparative Study to Evaluate FORTOVASE (Saquinavir) Soft Gel Capsule (SGC) TID Regimen in Combination With Two NRTI's in HIV-1 Infected Women and Men

The purpose of this study is to see if it is safe and effective to give saquinavir (as a soft gel capsule taken by mouth) along with 2 other anti-HIV drugs to HIV-infected patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Prior to initiation of study treatment all patients are screened and baseline lab values are taken. Patients then receive the study treatment, FORTOVASE, two times a day plus 2 new NRTI's. Assessments will be performed at specified intervals throughout the duration of treatment.

Study Type

Interventional

Enrollment

80

Phase

  • Phase 4

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

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
        • Univ of British Columbia Oak Tree Clinic
  • Puerto Rico
      • San Turce, Puerto Rico, 00908
        • Programe DeSIDA De San Juan
  • United States
    • Alabama
      • Hobson City, Alabama, United States, 36201
        • ASC Inc
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Dean Martin
    • California
      • Paramount, California, United States, 90723
        • Wilbert Jordan
    • District of Columbia
      • Washington, District of Columbia, United States, 20009
        • Whitman Walker Clinic
    • Florida
      • Jacksonville, Florida, United States, 32206
        • Duval County Health Department
      • Tampa, Florida, United States, 33609
        • Ctr for Quality Care
    • Georgia
      • Decatur, Georgia, United States, 30033
        • NTouch Research Corp
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Univ of Illinois Hosp at Chicago
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Univ of Kentucky
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • C100 HIV Outpatient Program
    • New Jersey
      • Newark, New Jersey, United States, 07103
        • UMDNJ / Dept of Ob/Gyn
      • Newark, New Jersey, United States, 07103
        • NJ CRI
    • New York
      • Brooklyn, New York, United States, 11203
        • SUNY Health Sciences Ctr
      • Brooklyn, New York, United States, 11212
        • Brookdale Univ Med Ctr
      • Mt. Vernon, New York, United States, 10550
        • Mt Vernon Hosp
      • New York, New York, United States, 100296574
        • Mount Sinai Med Ctr
      • New York, New York, United States, 10037
        • Harlem Hosp Infectious Disease
    • Rhode Island
      • Pawtucket, Rhode Island, United States, 02860
        • Mem Hosp of Rhode Island
    • Texas
      • Houston, Texas, United States, 77027
        • Diversified Med Practices, PA
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Univ of Virginia Health Sciences Ctr

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 to 64 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

You may be eligible for this study if you:

  • Are HIV-positive.
  • Have an HIV count of 5,000 copies/ml or more.
  • Have a CD4 count of 100 cells/mm3 or more.
  • Meet specific requirements if you have ever taken NRTIs.
  • Are 16 - 64 years old (need consent if under 18).
  • Agree to use effective methods of birth control during the study.

Exclusion Criteria

You will not be eligible for this study if you:

  • Have taken non-nucleoside reverse transcriptase inhibitors (NNRTIs) or protease inhibitors (PIs) for more than 2 weeks.
  • Have taken all the available NRTIs.
  • Have certain serious medical conditions, including severe liver disease or active opportunistic (AIDS-related) infection.
  • Have a history of weight loss, muscle pain, and loss of appetite.
  • Have taken certain medications, including anti-HIV drugs other than those required by this study.
  • Are pregnant or breast-feeding.
  • Abuse alcohol or drugs.
  • Are unable to complete the study for any reason.

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
  • Masking: None (Open Label)

Collaborators and Investigators

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

Sponsor

Hoffmann-La Roche

Investigators

  • Study Chair: S Palleja
  • Study Chair: C Karol

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, 1999

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 229Q
  • NR15750

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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