HIV Infections
Conditions
Keywords
Drug Therapy, Combination, HIV Protease Inhibitors, Dosage Forms, Saquinavir, Reverse Transcriptase Inhibitors, Anti-HIV Agents
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.
Detailed description
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.
Interventions
DRUGSaquinavir
Sponsors
Hoffmann-La Roche
Study design
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 64 Years
Healthy volunteers
No
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.
Countries
Canada, Puerto Rico, United States
Outcome results
None listed