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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

NCT ID: NCT00002229

Last Updated: 2005-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Brief Summary

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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

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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.

Conditions

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HIV Infections

Study Design

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Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Saquinavir

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

16 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Principal Investigators

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S Palleja

Role: STUDY_CHAIR

C Karol

Role: STUDY_CHAIR

Locations

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ASC Inc

Hobson City, Alabama, United States

Site Status

Dean Martin

Phoenix, Arizona, United States

Site Status

Wilbert Jordan

Paramount, California, United States

Site Status

Whitman Walker Clinic

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

Site Status

Duval County Health Department

Jacksonville, Florida, United States

Site Status

Ctr for Quality Care

Tampa, Florida, United States

Site Status

NTouch Research Corp

Decatur, Georgia, United States

Site Status

Univ of Illinois Hosp at Chicago

Chicago, Illinois, United States

Site Status

Univ of Kentucky

Lexington, Kentucky, United States

Site Status

C100 HIV Outpatient Program

New Orleans, Louisiana, United States

Site Status

NJ CRI

Newark, New Jersey, United States

Site Status

UMDNJ / Dept of Ob/Gyn

Newark, New Jersey, United States

Site Status

SUNY Health Sciences Ctr

Brooklyn, New York, United States

Site Status

Brookdale Univ Med Ctr

Brooklyn, New York, United States

Site Status

Mt Vernon Hosp

Mount Vernon, New York, United States

Site Status

Mount Sinai Med Ctr

New York, New York, United States

Site Status

Harlem Hosp Infectious Disease

New York, New York, United States

Site Status

Mem Hosp of Rhode Island

Pawtucket, Rhode Island, United States

Site Status

Diversified Med Practices, PA

Houston, Texas, United States

Site Status

Univ of Virginia Health Sciences Ctr

Charlottesville, Virginia, United States

Site Status

Univ of British Columbia Oak Tree Clinic

Vancouver, British Columbia, Canada

Site Status

Programe DeSIDA De San Juan

Santurce, , Puerto Rico

Site Status

Countries

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United States Canada Puerto Rico

Other Identifiers

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NR15750

Identifier Type: -

Identifier Source: secondary_id

229Q

Identifier Type: -

Identifier Source: org_study_id