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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
Sponsored by: 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

MedlinePlus related topics: AIDS
Drug Information available for: Zidovudine Lamivudine Abacavir Nelfinavir Nelfinavir Mesylate VX 478 Abacavir sulfate
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

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

Study placed in the following topic categories:
HIV Protease Inhibitors
Sexually Transmitted Diseases, Viral
Anti-HIV Agents
Acquired Immunodeficiency Syndrome
Zidovudine
Lamivudine
Antiviral Agents
Immunologic Deficiency Syndromes
Protease Inhibitors
Reverse Transcriptase Inhibitors
Virus Diseases
Anti-Bacterial Agents
Amprenavir
Anti-Retroviral Agents
HIV Infections
Sexually Transmitted Diseases
Antitubercular Agents
Abacavir
Nelfinavir
Retroviridae Infections

Additional relevant MeSH terms:
Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Infection
Reverse Transcriptase Inhibitors
Anti-Bacterial Agents
Amprenavir
Anti-Retroviral Agents
Therapeutic Uses
Abacavir
Nelfinavir
Retroviridae Infections
Nucleic Acid Synthesis Inhibitors
RNA Virus Infections
HIV Protease Inhibitors
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
Sexually Transmitted Diseases
Lentivirus Infections
Antitubercular Agents

ClinicalTrials.gov processed this record on May 07, 2009