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A Study of Retrovir and Epivir Alone or in Combination With 141W94 in HIV-Infected Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00002195
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
November 2, 1999
August 31, 2001
December 9, 2005
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No Changes Posted
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A Study of Retrovir and Epivir Alone or in Combination With 141W94 in HIV-Infected Patients
A Phase III Trial to Evaluate the Safety and Antiviral Efficacy of 141W94 in Combination With Retrovir and Epivir Compared to Retrovir and Epivir Alone in Patients With HIV Infection.
The purpose of this study is to see if it is safe and effective to add 141W94 to an anti-HIV regimen that includes retrovir plus epivir.
This is a double-blind, placebo-controlled, two-arm study comparing treatment with a triple regimen consisting of 141W94, retrovir, and epivir and a double regimen consisting of retrovir and epivir.
Interventional
Phase 3
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
HIV Infections
  • Drug: Amprenavir
  • Drug: Lamivudine
  • Drug: Zidovudine
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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
290
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Inclusion Criteria

Patients must have:

  • HIV-positive status.
  • Screening viral load >= 10,000 copies/mm3 14 days prior to entry.
  • CD4+ cell counts >= 200 cells/mm3 14 days prior to entry.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

Clinical diagnosis of AIDS (CDC 1993 Classification C).

Concurrent Medication:

Excluded:

Terfenadine, astemizole, cisapride, triazolam, medazolam, and ergotamine/dihydroergotamine-containing regimens.

Patients with the following prior conditions are excluded:

Clinically relevant hepatitis in the previous 6 months.

Prior Medication:

Excluded:

  • Greater than 4 weeks of any nucleoside antiretroviral therapy.
  • Previous therapy with an HIV protease inhibitor.
  • Cytotoxic chemotherapeutic agents within 4 weeks prior to entry.
  • Immunomodulating agents within 3 months prior to entry.

Prior Treatment:

Excluded:

Radiotherapy within 4 weeks prior to entry.

Risk Behavior:

Excluded:

Current alcohol or illicit drug use that may interfere with the patient's ability to comply with the dosing schedule or protocol evaluations.

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00002195
264D
PROA3001
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Glaxo Wellcome
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NIH AIDS Clinical Trials Information Service
November 1998

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