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

This study has been completed.

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

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

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:	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.

Resource links provided by NLM:

MedlinePlus related topics: AIDS

Drug Information available for: Zidovudine Lamivudine Abacavir Nelfinavir Nelfinavir Mesylate VX 478 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
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

No publications provided

Study ID Numbers:	280C, UNAP 11, NZTA 4002
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002216 History of Changes
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:

Antimetabolites
Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Zidovudine
Lamivudine
Infection
Reverse Transcriptase Inhibitors
Anti-Bacterial Agents
Amprenavir
Anti-Retroviral Agents
Therapeutic Uses
Abacavir
Nelfinavir

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
Antibiotics, Antitubercular
Protease Inhibitors
Virus Diseases
HIV Infections

ClinicalTrials.gov processed this record on November 22, 2009