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

Launched by GLAXO WELLCOME · Aug 30, 2001

Keywords

ClinConnect Summary

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.

Gender

ALL

Eligibility 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.