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

Hoffmann-La Roche80 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

HIV Infections

Interventions

SaquinavirDRUG

Eligibility

Sex: ALLMin age: 16 YearsMax age: 64 Years

Medical Language ↔ Plain English

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.

Locations (22)

ASC Inc

Hobson City, Alabama, United States

Data from ClinicalTrials.gov

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