Safety and Effectiveness of Adding Saquinavir (FORTOVASE) in Soft Gel Capsule Form to an Anti-HIV Drug Combination in HIV-Infected Patients
Information provided by (Responsible Party)
NIH AIDS Clinical Trials Information Service
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.
Drug : Saquinavir
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:
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.Eligibility
|Ages Eligible for Study:||16 Years to 64 Years|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
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.
- 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.
You will not be eligible for this study if you:
Contacts and LocationsChoosing 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 ClinicalTrials.gov identifier: NCT00002229
Locations Show More
|United States, Alabama|
|Hobson City, Alabama, United States, 36201|
|United States, Arizona|
|Phoenix, Arizona, United States, 85006|
|United States, California|
|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|
|Programe DeSIDA De San Juan|
|San Turce, Puerto Rico, 00908|
Sponsors and CollaboratorsHoffmann-La Roche
|Study Chair:||S Palleja|
|Study Chair:||C Karol|
|Responsible Party:||Hoffmann-La Roche|
|ClinicalTrials.gov 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
Reverse Transcriptase Inhibitors
Additional relevant MeSH terms:
ClinicalTrials.gov processed this data on December 06, 2019
This information is provided by ClinicalTrials.gov.