A Study of Saquinavir Soft Gelatin Capsules Plus Zidovudine Plus Lamivudine in the Treatment of HIV-1 Infected Patients Who Have Never Taken Anti-HIV Drugs - Full Text View

A Study of Saquinavir Soft Gelatin Capsules Plus Zidovudine Plus Lamivudine in the Treatment of HIV-1 Infected Patients Who Have Never Taken Anti-HIV Drugs

This study has been completed.

Sponsored by:	Hoffmann-La Roche
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00002367

Purpose

To evaluate the efficacy of Saquinavir-SGC combination with Zidovudine and Lamivudine in the treatment of HIV-1 infected patients with no previous anti-retroviral drug therapy.

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

MedlinePlus related topics:

AIDS AIDS Medicines

Drug Information available for:

Zidovudine Lamivudine Saquinavir Saquinavir mesylate Gelatin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Parallel Assignment, Safety Study

Official Title:	An Open-Label, Non-Comparative Study of Saquinavir-SGC in Combination With Zidovudine (AZT) and Lamivudine (3TC) in the Treatment of HIV-1 Infected Patients With No Previous Anti-Retroviral Drug Therapy

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

Estimated Enrollment:

Detailed Description:

All enrolled patients will receive the following 3 drug combination: Saquinavir, Zidovudine and Lamivudine. Efficacy and duration of anti-viral response will be evaluated by monitoring of HIV-1 RNA levels. Patients below the detectable limit of 200 copies/ml will be analyzed using the Ultra-direct method with a detection limit of 20 copies/ml. CD4 and CD8 cell counts will also be analyzed.

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria

Patients must have:

Plasma HIV-1 RNA titers > 10,000 copies/ml.
CD4 cell count > 100 cells/mm3.

Exclusion Criteria

Co-existing Condition:

Patients with any of the following conditions will be excluded:

Any prior anti-retroviral drug therapy.

Prior Medication:

Excluded:

Previous anti-retroviral drug therapy.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002367

Locations


United States, California
	AIDS Healthcare Foundation Labs
	Los Angeles, California, United States, 90048

United States, Florida
	Urgent Care Ctr / North Broward Hosp District
	Fort Lauderdale, Florida, United States, 33316

Sponsors and Collaborators

Hoffmann-La Roche

More Information

Study ID Numbers:	229F, NR15503, M61005
First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002367
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:

Drug Therapy, Combination

Acquired Immunodeficiency Syndrome

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 November 20, 2008