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

This study has been completed.

Sponsor:

Information provided by:

NIH AIDS Clinical Trials Information Service

ClinicalTrials.gov Identifier:

NCT00002216

First received: November 2, 1999

Last updated: June 23, 2005

Last verified: May 1999

History of Changes

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


Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study Masking: Open Label Primary Purpose: Treatment
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.

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Zidovudine Lamivudine Abacavir Nelfinavir Nelfinavir Mesylate Amprenavir Abacavir sulfate

U.S. FDA Resources

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 (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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


ClinicalTrials.gov Identifier:	NCT00002216 History of Changes
Other Study ID Numbers:	280C UNAP 11 NZTA 4002
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 VX 478	Reverse Transcriptase Inhibitors Anti-HIV Agents abacavir

Additional relevant MeSH terms:


HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Abacavir Lamivudine Zidovudine Lamivudine, zidovudine drug combination Reverse Transcriptase Inhibitors Nelfinavir	Amprenavir Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Anti-HIV Agents Antimetabolites HIV Protease Inhibitors Protease Inhibitors Antibiotics, Antitubercular Antitubercular Agents Anti-Bacterial Agents

ClinicalTrials.gov processed this record on September 26, 2016

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