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NCT00002229 Clinical Trial

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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00002229
Other study ID # 229Q
Secondary ID NR15750
Status Completed
Phase Phase 4
First received November 2, 1999
Last updated June 23, 2005

Study information
Verified date December 1999
Source NIH AIDS Clinical Trials Information Service
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

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 information / eligibility
Status Completed
Enrollment 80
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 16 Years to 64 Years
Eligibility 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.

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• Saquinavir

Locations
Country Name City State
Canada Univ of British Columbia Oak Tree Clinic Vancouver British Columbia
Puerto Rico Programe DeSIDA De San Juan San Turce
United States Brookdale Univ Med Ctr Brooklyn New York
United States SUNY Health Sciences Ctr Brooklyn New York
United States Univ of Virginia Health Sciences Ctr Charlottesville Virginia
United States Univ of Illinois Hosp at Chicago Chicago Illinois
United States NTouch Research Corp Decatur Georgia
United States ASC Inc Hobson City Alabama
United States Diversified Med Practices, PA Houston Texas
United States Duval County Health Department Jacksonville Florida
United States Univ of Kentucky Lexington Kentucky
United States Mt Vernon Hosp Mt. Vernon New York
United States C100 HIV Outpatient Program New Orleans Louisiana
United States Harlem Hosp Infectious Disease New York New York
United States Mount Sinai Med Ctr New York New York
United States NJ CRI Newark New Jersey
United States UMDNJ / Dept of Ob/Gyn Newark New Jersey
United States Wilbert Jordan Paramount California
United States Mem Hosp of Rhode Island Pawtucket Rhode Island
United States Dean Martin Phoenix Arizona
United States Ctr for Quality Care Tampa Florida
United States Whitman Walker Clinic Washington District of Columbia

Sponsors (1)
Lead Sponsor Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Canada,  Puerto Rico, 

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