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

Condition	Treatment or Intervention
HIV Infections	Drug: Lamivudine/Zidovudine  Drug: Abacavir sulfate  Drug: Amprenavir  Drug: Nelfinavir mesylate

Further Study Details: 

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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.

Pennsylvania
      Anderson Clinical Research, Pittsburgh,  Pennsylvania,  15213,  United States

Study ID Numbers:  280C; UNAP 11; NZTA 4002
Record last reviewed:  May 1999
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00002216
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08