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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002217
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: May 1999

November 2, 1999
June 23, 2005
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Complete list of historical versions of study NCT00002217 on ClinicalTrials.gov Archive Site
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A Study of Combivir Plus Abacavir Plus 141W94 in Patients Who Previously Have Used Anti-HIV Drugs
Combivir, 1592U89, 141W94 Triple Antiretroviral, Experienced Patient Trial

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.

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

Interventional
Not Provided
Endpoint Classification: Safety Study
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
  • Drug: Lamivudine/Zidovudine
  • Drug: Abacavir sulfate
  • Drug: Amprenavir
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002217
280D, UNAP 12, NZTA 4005
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Glaxo Wellcome
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NIH AIDS Clinical Trials Information Service
May 1999

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP