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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

Phase 4
Completed
Conditions
HIV Infections
Registration Number
NCT00002229
Lead Sponsor
Hoffmann-La Roche
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
80
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (22)

Univ of Illinois Hosp at Chicago

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Chicago, Illinois, United States

Programe DeSIDA De San Juan

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San Turce, Puerto Rico

Univ of Virginia Health Sciences Ctr

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Charlottesville, Virginia, United States

Univ of British Columbia Oak Tree Clinic

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Vancouver, British Columbia, Canada

SUNY Health Sciences Ctr

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Brooklyn, New York, United States

Mount Sinai Med Ctr

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New York, New York, United States

Brookdale Univ Med Ctr

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Brooklyn, New York, United States

Mt Vernon Hosp

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Mt. Vernon, New York, United States

UMDNJ / Dept of Ob/Gyn

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Newark, New Jersey, United States

Mem Hosp of Rhode Island

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Pawtucket, Rhode Island, United States

Dean Martin

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Phoenix, Arizona, United States

Harlem Hosp Infectious Disease

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New York, New York, United States

Diversified Med Practices, PA

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Houston, Texas, United States

ASC Inc

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Hobson City, Alabama, United States

Wilbert Jordan

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Paramount, California, United States

Whitman Walker Clinic

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Washington, District of Columbia, United States

Ctr for Quality Care

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Tampa, Florida, United States

NTouch Research Corp

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Decatur, Georgia, United States

Duval County Health Department

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Jacksonville, Florida, United States

C100 HIV Outpatient Program

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New Orleans, Louisiana, United States

Univ of Kentucky

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Lexington, Kentucky, United States

NJ CRI

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Newark, New Jersey, United States

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