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

Sponsor:	Hoffmann-La Roche
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00002229

Purpose

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.

Condition	Intervention	Phase
HIV Infections	Drug: Saquinavir	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Open Label, Pharmacokinetics Study
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

Resource links provided by NLM:

MedlinePlus related topics: AIDS AIDS Medicines

Drug Information available for: Saquinavir Saquinavir mesylate

U.S. FDA Resources

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment:

80

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

Ages Eligible for Study:	16 Years to 64 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002229

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Locations

United States, Alabama
ASC Inc
Hobson City, Alabama, United States, 36201
United States, Arizona
Dean Martin
Phoenix, Arizona, United States, 85006
United States, California
Wilbert Jordan
Paramount, California, United States, 90723
United States, District of Columbia
Whitman Walker Clinic
Washington, District of Columbia, United States, 20009
United States, Florida
Ctr for Quality Care
Tampa, Florida, United States, 33609
Duval County Health Department
Jacksonville, Florida, United States, 32206
United States, Georgia
NTouch Research Corp
Decatur, Georgia, United States, 30033
United States, Illinois
Univ of Illinois Hosp at Chicago
Chicago, Illinois, United States, 60612
United States, Kentucky
Univ of Kentucky
Lexington, Kentucky, United States, 40536
United States, Louisiana
C100 HIV Outpatient Program
New Orleans, Louisiana, United States, 70112
United States, New Jersey
UMDNJ / Dept of Ob/Gyn
Newark, New Jersey, United States, 07103
NJ CRI
Newark, New Jersey, United States, 07103
United States, New York
Brookdale Univ Med Ctr
Brooklyn, New York, United States, 11212
SUNY Health Sciences Ctr
Brooklyn, New York, United States, 11203
Harlem Hosp Infectious Disease
New York, New York, United States, 10037
Mount Sinai Med Ctr
New York, New York, United States, 100296574
Mt Vernon Hosp
Mt. Vernon, New York, United States, 10550
United States, Rhode Island
Mem Hosp of Rhode Island
Pawtucket, Rhode Island, United States, 02860
United States, Texas
Diversified Med Practices, PA
Houston, Texas, United States, 77027
United States, Virginia
Univ of Virginia Health Sciences Ctr
Charlottesville, Virginia, United States, 22908
Canada, British Columbia
Univ of British Columbia Oak Tree Clinic
Vancouver, British Columbia, Canada
Puerto Rico
Programe DeSIDA De San Juan
San Turce, Puerto Rico, 00908

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Chair:	S Palleja
Study Chair:	C Karol

More Information

No publications provided

Study ID Numbers:	229Q, NR15750
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002229 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:

Drug Therapy, Combination
HIV Protease Inhibitors
Dosage Forms

Saquinavir
Reverse Transcriptase Inhibitors
Anti-HIV Agents

Additional relevant MeSH terms:

Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Saquinavir
Infection
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Retroviridae Infections
Nucleic Acid Synthesis Inhibitors
RNA Virus Infections
HIV Protease Inhibitors

Anti-HIV Agents
Immune System Diseases
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Antiviral Agents
Immunologic Deficiency Syndromes
Pharmacologic Actions
Protease Inhibitors
Virus Diseases
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections

ClinicalTrials.gov processed this record on November 27, 2009