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

Completed · Phase 4

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00002229

Run by

Hoffmann-La Roche

People needed

80

Last updated by the study team

2005-06-24

Who can join

Age: 16 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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