Safety and Effectiveness of Adding Saquinavir (FORTOVASE) in Soft Gel Capsule Form to an Anti-HIV Drug Combination in HIV-Infected Patients
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
2 other identifiers
interventional
80
3 countries
22
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 hiv-infections
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
December 1, 1999
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
ASC Inc
Hobson City, Alabama, 36201, United States
Dean Martin
Phoenix, Arizona, 85006, United States
Wilbert Jordan
Paramount, California, 90723, United States
Whitman Walker Clinic
Washington D.C., District of Columbia, 20009, United States
Duval County Health Department
Jacksonville, Florida, 32206, United States
Ctr for Quality Care
Tampa, Florida, 33609, United States
NTouch Research Corp
Decatur, Georgia, 30033, United States
Univ of Illinois Hosp at Chicago
Chicago, Illinois, 60612, United States
Univ of Kentucky
Lexington, Kentucky, 40536, United States
C100 HIV Outpatient Program
New Orleans, Louisiana, 70112, United States
NJ CRI
Newark, New Jersey, 07103, United States
UMDNJ / Dept of Ob/Gyn
Newark, New Jersey, 07103, United States
SUNY Health Sciences Ctr
Brooklyn, New York, 11203, United States
Brookdale Univ Med Ctr
Brooklyn, New York, 11212, United States
Mt Vernon Hosp
Mount Vernon, New York, 10550, United States
Mount Sinai Med Ctr
New York, New York, 100296574, United States
Harlem Hosp Infectious Disease
New York, New York, 10037, United States
Mem Hosp of Rhode Island
Pawtucket, Rhode Island, 02860, United States
Diversified Med Practices, PA
Houston, Texas, 77027, United States
Univ of Virginia Health Sciences Ctr
Charlottesville, Virginia, 22908, United States
Univ of British Columbia Oak Tree Clinic
Vancouver, British Columbia, Canada
Programe DeSIDA De San Juan
Santurce, 00908, Puerto Rico
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
S Palleja
- STUDY CHAIR
C Karol