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.

First Received on November 2, 1999. Last Updated on June 23, 2005 History of Changes

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

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS HIV/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:

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

No publications provided

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

HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
HIV Protease Inhibitors

Saquinavir
Reverse Transcriptase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on February 09, 2012