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

NCT ID: NCT00002217

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 test the effectiveness of Combivir plus abacavir plus 141W94 in patients who previously have used anti-HIV drugs.

Detailed Description

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

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

Eligibility Criteria

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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.
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

References

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Henry K, Shaeffer M, Ross L, Johnson M, Fisher R, Liao Q, Graham N. Response to Combivir and abacavir given bid to nucleoside experienced patients is not affected by the presence of the M184V mutation. 6th Conf Retro and Opportun Infect. 1999 Jan 31 - Feb 4 (abstract no 132)

Reference Type BACKGROUND

Henry K, Wallace RJ, Bellman PC, Norris D, Fisher RL, Ross LL, Liao Q, Shaefer MS; TARGET Study Team. Twice-daily triple nucleoside intensification treatment with lamivudine-zidovudine plus abacavir sustains suppression of human immunodeficiency virus type 1: results of the TARGET Study. J Infect Dis. 2001 Feb 15;183(4):571-8. doi: 10.1086/318527. Epub 2001 Jan 11.

Reference Type BACKGROUND
PMID: 11170982 (View on PubMed)

Other Identifiers

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UNAP 12

Identifier Type: -

Identifier Source: secondary_id

NZTA 4005

Identifier Type: -

Identifier Source: secondary_id

280D

Identifier Type: -

Identifier Source: org_study_id