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

NCT ID: NCT00002216

Last Updated: 2005-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Brief Summary

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

Detailed Description

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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.

Conditions

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HIV Infections

Study Design

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Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Lamivudine/Zidovudine

Intervention Type DRUG

Abacavir sulfate

Intervention Type DRUG

Amprenavir

Intervention Type DRUG

Nelfinavir mesylate

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Glaxo Wellcome

INDUSTRY

Sponsor Role lead

Locations

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Anderson Clinical Research

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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UNAP 11

Identifier Type: -

Identifier Source: secondary_id

NZTA 4002

Identifier Type: -

Identifier Source: secondary_id

280C

Identifier Type: -

Identifier Source: org_study_id