Clinical Trials


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

This study has been completed
Hoffmann-La Roche

Information provided by (Responsible Party)
NIH AIDS Clinical Trials Information Service Identifier

First received: November 2, 1999
Last updated: June 23, 2005
Last Verified: December 1999
History of Changes


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.

Condition Intervention Phase
HIV Infections

Drug : Saquinavir
Phase 4

Study Type: Interventional
Study Design: Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

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

Enrollment: 80

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.



Ages Eligible for Study: 16 Years to 64 Years  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  


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.

contacts and locations

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 identifier: NCT00002229


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

Sponsors and Collaborators

Hoffmann-La Roche


Study Chair: S Palleja
Study Chair: C Karol
More Information

More Information

Responsible Party: Hoffmann-La Roche Identifier: NCT00002229   History of Changes  
Other Study ID Numbers: 229Q  
Study First Received: November 2, 1999  
Last Updated: June 23, 2005  

Keywords provided by NIH AIDS Clinical Trials Information Service:

Drug Therapy, Combination
HIV Protease Inhibitors
Dosage Forms
Reverse Transcriptase Inhibitors
Anti-HIV Agents

Additional relevant MeSH terms:
HIV Infections
Saquinavir processed this data on May 29, 2020
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