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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

Information source: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV Infections

Intervention: Saquinavir (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Hoffmann-La Roche

Official(s) and/or principal investigator(s):
S Palleja, Study Chair
C Karol, Study Chair

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.

Clinical Details

Official title: 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

Study design: Endpoint Classification: Pharmacokinetics Study, Masking: Open Label, Primary Purpose: Treatment

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

Minimum age: 16 Years. Maximum age: 64 Years. Gender(s): Both.

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.

Locations and Contacts

Programe DeSIDA De San Juan, San Turce 00908, Puerto Rico

ASC Inc, Hobson City, Alabama 36201, United States

Dean Martin, Phoenix, Arizona 85006, United States

Univ of British Columbia Oak Tree Clinic, Vancouver, British Columbia, Canada

Wilbert Jordan, Paramount, California 90723, United States

Whitman Walker Clinic, Washington, District of Columbia 20009, United States

Duval County Health Department, Jacksonville, Florida 32206, United States

Ctr for Quality Care, Tampa, Florida 33609, United States

NTouch Research Corp, Decatur, Georgia 30033, United States

Univ of Illinois Hosp at Chicago, Chicago, Illinois 60612, United States

Univ of Kentucky, Lexington, Kentucky 40536, United States

C100 HIV Outpatient Program, New Orleans, Louisiana 70112, United States

NJ CRI, Newark, New Jersey 07103, United States

UMDNJ / Dept of Ob/Gyn, Newark, New Jersey 07103, United States

Brookdale Univ Med Ctr, Brooklyn, New York 11212, United States

SUNY Health Sciences Ctr, Brooklyn, New York 11203, United States

Mt Vernon Hosp, Mt. Vernon, New York 10550, United States

Harlem Hosp Infectious Disease, New York, New York 10037, United States

Mount Sinai Med Ctr, New York, New York 100296574, United States

Mem Hosp of Rhode Island, Pawtucket, Rhode Island 02860, United States

Diversified Med Practices, PA, Houston, Texas 77027, United States

Univ of Virginia Health Sciences Ctr, Charlottesville, Virginia 22908, United States

Additional Information


Last updated: June 23, 2005

Page last updated: August 23, 2015

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