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

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

A Phase IV, Non-Comparative Study to Evaluate FORTOVASE (Saquinavir) Soft Gel Capsule (SGC) TID Regimen in Combination With Two NRTI's in HIV-1 Infected Women and Men

NCT00002229•Hoffmann-La Roche

View on ClinicalTrials.gov

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.

Eligibility

Age

16 - 64 years

Sex

ALL

Healthy Volunteers

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

Dean Martin

Phoenix, Arizona, United States

Wilbert Jordan

Paramount, California, United States

Whitman Walker Clinic

Washington D.C., District of Columbia, United States

Duval County Health Department

Jacksonville, Florida, United States

Ctr for Quality Care

Tampa, Florida, United States

NTouch Research Corp

Decatur, Georgia, United States

Univ of Illinois Hosp at Chicago

Chicago, Illinois, United States

Univ of Kentucky

Lexington, Kentucky, United States

C100 HIV Outpatient Program

New Orleans, Louisiana, United States

Key Dates

Last Updated

June 24, 2005

Enrollment

Estimated participants

Conditions

HIV Infections

Interventions

Saquinavir

DRUG

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NCT06694805

HIV Infections

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HIVHIV Infections

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 24, 2005Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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