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

GlaxoSmithKline (GSK)

Status: Completed

Conditions: HIV Infections

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00002217

UNAP 12

NZTA 4005

280D

Details and patient eligibility

About

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.

Full description

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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.