A Comparison of Two Multi-Drug Therapies in HIV-Infected Patients Who Have Never Received Anti-HIV Treatment - Full Text View

Purpose

The purpose of this study is to compare 2 combination drug therapies in HIV-infected patients who have never received anti-HIV treatment.

Condition	Intervention
HIV Infections	Drug: Lamivudine/Zidovudine Drug: Abacavir sulfate Drug: Amprenavir Drug: Nelfinavir mesylate

MedlinePlus related topics:

AIDS

Drug Information available for:

Zidovudine Abacavir Abacavir sulfate Lamivudine Nelfinavir Nelfinavir Mesylate Combivir VX 478

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Efficacy Study

Official Title:	A Comparison of a Four-Drug Regimen Comprised of 141W94, 1592U89, and Combivir With a Three-Drug Regimen Comprised of Nelfinavir and Combivir in Antiretroviral-Naive HIV-Infected Patients.

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

Detailed Description:

In this open-label study antiretroviral-naive patients are randomized to one of two drug regimens:

Arm I: 141W94 (amprenavir), 1592U89 (abacavir), and Combivir (3TC/AZT tablet). Arm II: Nelfinavir and Combivir.

Eligibility

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

Criteria

Inclusion Criteria

Patients must have:

CD4 count > 50.
HIV RNA > 5,000.
No active AIDS (excluding CD4 count < 200).
Ability to comply with dosing schedule and protocol evaluations.

Prior Medication:

Allowed:

3TC or any protease inhibitor, if < 1 week of therapy.
Other nucleoside analogs, if < 4 weeks of therapy.

Exclusion Criteria

Co-existing Condition:

Patients with any of the following symptoms or conditions are excluded:

Active AIDS (not including CD4 count < 200).
Malabsorption syndrome affecting drug absorption.

Concurrent Medication:

Excluded:

Enrollment in any other investigational drug protocol.

Prior Medication:

Excluded:

Non-nucleoside reverse transcriptase inhibitors.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002216

Locations


United States, Pennsylvania
	Anderson Clinical Research
	Pittsburgh, Pennsylvania, United States, 15213

Sponsors and Collaborators

Glaxo Wellcome

More Information

Study ID Numbers:	280C, UNAP 11, NZTA 4002
First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002216
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:

Drug Therapy, Combination

HIV Protease Inhibitors

VX 478

Reverse Transcriptase Inhibitors

Anti-HIV Agents

abacavir

Study placed in the following topic categories:

Virus Diseases

Amprenavir

Sexually Transmitted Diseases, Viral

HIV Infections

Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome

Lamivudine

Zidovudine

Nelfinavir

Abacavir

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

Reverse Transcriptase Inhibitors

Antibiotics, Antitubercular

Protease Inhibitors

Anti-Bacterial Agents

Anti-Retroviral Agents

Therapeutic Uses

Lentivirus Infections

Antitubercular Agents

Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on December 03, 2008

Sponsored by:	Glaxo Wellcome
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00002216