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OpenTrials
Completed

NCT Number: NCT00002217

A Study of Combivir Plus Abacavir Plus 141W94 in Patients Who Previously Have Used Anti-HIV Drugs

The purpose of this study is to test the effectiveness of Combivir plus abacavir plus 141W94 in patients who previously have used anti-HIV drugs.

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Key information

About this study

In this open-label study antiretroviral-experienced patients receive Combivir (3TC/AZT tablet) plus 1592U89 (abacavir) and 141W94 twice daily for 48 weeks.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients must have:

  • CD4 count greater than 50 cells/mm3.
  • HIV RNA less than 50,000 copies/ml.
  • No active AIDS (excluding CD4 count less than 200 cells/mm3).
  • Ability to comply with dosing schedule and protocol evaluations.

Prior Medication:

Allowed:

AZT or non-nucleoside reverse transcriptase inhibitors (NNRTIs).

Exclusion criteria

Co-existing Condition:

Patients with any of the following symptoms or conditions are excluded:

  • Active AIDS (not excluding CD4 count less than 200).
  • Malabsorption syndrome affecting drug absorption.
  • Serious medical condition that would compromise safety of the patient.

Concurrent Medication:

Excluded:

  • AZT or NNRTIs.
  • More than 1 week treatment with any protease inhibitor.
  • Enrollment in any other investigational drug protocol.

Patients with the following prior conditions are excluded:

History of clinically relevant pancreatitis or hepatitis within the past 6 months.

Required:

Antiretroviral therapy with either single or double reverse transcriptase inhibitors.

Treatment and study plan

Lamivudine/Zidovudine

Drug

Abacavir sulfate

Drug

Amprenavir

Drug

Sponsors and collaborators

Lead sponsor

Glaxo Wellcome

Industry

Registry information

Official study title

Combivir, 1592U89, 141W94 Triple Antiretroviral, Experienced Patient Trial

Important dates

First posted
Aug 31, 2001
Registry last updated
Jun 24, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.