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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00002216
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
Information provided by:
NIH AIDS Clinical Trials Information Service

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

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Lamivudine/Zidovudine Drug: Abacavir sulfate Drug: Amprenavir Drug: Nelfinavir mesylate Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Masking: None (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 the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00002216

United States, Pennsylvania
Anderson Clinical Research
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
Glaxo Wellcome Identifier: NCT00002216     History of Changes
Other Study ID Numbers: 280C
NZTA 4002
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: May 1999

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