Safety and Effectiveness of Adding Saquinavir (FORTOVASE) in Soft Gel Capsule Form to an Anti-HIV Drug Combination in HIV-Infected Patients
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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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 or disease
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.
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, Learn About Clinical Studies.
Ages Eligible for Study:
16 Years to 64 Years (Child, Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
You may be eligible for this study if you:
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 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.