We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00002216
First Posted: August 31, 2001
Last Update Posted: December 9, 2005
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.
Information provided by:
NIH AIDS Clinical Trials Information Service
  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: 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 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.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): 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
First Submitted: November 2, 1999
First Posted: August 31, 2001
Last Update Posted: December 9, 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
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
Lamivudine
Zidovudine
Abacavir
Lamivudine, zidovudine drug combination
Nelfinavir
Amprenavir
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
Antimetabolites
HIV Protease Inhibitors
Protease Inhibitors
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents