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

Launched by GLAXO WELLCOME · Aug 30, 2001

Keywords

ClinConnect Summary

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

Gender

ALL

Eligibility criteria

• • 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.