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

Roche

Status and phase: Completed; Phase 4

Conditions: HIV Infections

Treatments: Drug: Saquinavir

Study type: Interventional

Funder types: Industry

Identifiers

NCT00002229

229Q

NR15750

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 16 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.