A Phase II Open-Label Exploratory Study of Saquinavir + Zidovudine + Lamivudine in HIV Infected Patients

This study has been completed.

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

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

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

Resource links provided by NLM:

MedlinePlus related topics: AIDS

Drug Information available for: Zidovudine Saquinavir Lamivudine Saquinavir mesylate

U.S. FDA Resources

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

No publications provided

Study ID Numbers:	229N, NV15114
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002190 History of Changes
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:

Antimetabolites
Sexually Transmitted Diseases, Viral
HIV Protease Inhibitors
Anti-HIV Agents
Saquinavir
Acquired Immunodeficiency Syndrome
Zidovudine
Lamivudine
Antiviral Agents

Immunologic Deficiency Syndromes
Protease Inhibitors
Reverse Transcriptase Inhibitors
Virus Diseases
Anti-Retroviral Agents
HIV Infections
Sexually Transmitted Diseases
Retroviridae Infections

Additional relevant MeSH terms:

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

HIV Protease Inhibitors
RNA Virus Infections
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 July 02, 2009