A Phase II Open-Label Exploratory Study of Saquinavir + Zidovudine + Lamivudine 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:	NCT00002190

Purpose

To explore the antiviral efficacy, tolerability and safety of saquinavir plus zidovudine plus lamivudine.

Condition	Intervention	Phase
HIV Infections	Drug: Saquinavir Drug: Lamivudine Drug: Zidovudine	Phase II

MedlinePlus related topics: AIDS

Drug Information available for: Zidovudine Lamivudine Saquinavir Saquinavir mesylate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Safety Study
Official Title:	A Phase II Open-Label Exploratory Study of Saquinavir + Zidovudine + Lamivudine in HIV Infected Patients

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

Estimated Enrollment:

Detailed Description:

A total of 30 patients receive the triple drug regimen saquinavir plus zidovudine plus lamivudine until the completion of the analysis after at least 4 weeks of therapy.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria

Patients must have:

HIV antibody positive.
CD4 count >= 150 and <= 500 cells/mm3.

Exclusion Criteria

Prior Medication:

Excluded:

Prior antiretroviral therapy.
Prior protease inhibitor therapy.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002190

Locations

United States, California
Davies Med Ctr / c/o HIV Institute
San Francisco, California, United States, 94114
Pacific Oaks Med Group / Rsch & Scientific Investigation
Sherman Oaks, California, United States, 91403
United States, New York
Columbia Presbyterian Med Ctr
New York, New York, United States, 10032

Sponsors and Collaborators

Hoffmann-La Roche

More Information

Study ID Numbers:	229N, NV15114
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002190
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:

Drug Therapy, Combination
Zidovudine
HIV Protease Inhibitors
Lamivudine

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
Lamivudine
Zidovudine
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
HIV Protease Inhibitors
RNA Virus Infections
Anti-HIV Agents
Slow Virus Diseases
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors

Infection
Antiviral Agents
Pharmacologic Actions
Protease Inhibitors
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Lentivirus Infections
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on January 14, 2009