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

Launched by HOFFMANN-LA ROCHE · Aug 30, 2001

Keywords

ClinConnect Summary

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.

Gender

ALL

Eligibility criteria

• • 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.