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

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

This study has been completed.

Sponsored by:	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

MedlinePlus related topics:

AIDS AIDS Medicines

ChemIDplus related topics:

Saquinavir Saquinavir mesylate

U.S. FDA Resources

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

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

Estimated Enrollment:

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

Show 22 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

Investigators


Study Chair:	S Palleja

Study Chair:	C Karol

More Information

Study ID Numbers:	229Q, NR15750
First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002229
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

Study placed in the following topic categories:

Virus Diseases

Sexually Transmitted Diseases, Viral

Saquinavir

HIV Infections

Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome

Retroviridae Infections

Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Anti-Infective Agents

RNA Virus Infections

HIV Protease Inhibitors

Slow Virus Diseases

Anti-HIV Agents

Immune System Diseases

Molecular Mechanisms of Pharmacological Action

Enzyme Inhibitors

Infection

Antiviral Agents

Pharmacologic Actions

Protease Inhibitors

Anti-Retroviral Agents

Therapeutic Uses

Lentivirus Infections

ClinicalTrials.gov processed this record on September 05, 2008