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

This study has been completed.
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: May 1999
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:

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.


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

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:


  • 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:


Enrollment in any other investigational drug protocol.

Prior Medication:


Non-nucleoside reverse transcriptase inhibitors.

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

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

Additional relevant MeSH terms:
Lamivudine, zidovudine drug combination
Reverse Transcriptase Inhibitors
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
HIV Protease Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Protease Inhibitors

ClinicalTrials.gov processed this record on May 26, 2016