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

GlaxoSmithKline (GSK)

Status: Completed

Conditions: HIV Infections

Treatments: Drug: Lamivudine/Zidovudine; Drug: Abacavir sulfate; Drug: Amprenavir; Drug: Nelfinavir mesylate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00002216

NZTA 4002

280C

UNAP 11

Details and patient eligibility

About

The purpose of this study is to compare 2 combination drug therapies in HIV-infected patients who have never received anti-HIV treatment.

Full description

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.