Clinical trial NCT00002229: Safety and Effectiveness of Adding Saquinavir (FORTOVASE) in Soft Gel Capsule Form to an Anti-HIV Drug Combination in HIV-Infected Patients
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV Infections
Keywords: Drug Therapy, Combination
HIV Protease Inhibitors
Dosage Forms
Saquinavir
Reverse Transcriptase Inhibitors
Anti-HIV Agents
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 80
Sex: ALL
Minimum age (years): 16
Maximum age (years): 64
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

Eligibility 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.

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