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

Purpose

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.

Condition	Intervention
HIV Infections	Drug: Lamivudine/Zidovudine Drug: Abacavir sulfate Drug: Amprenavir

MedlinePlus related topics:

AIDS AIDS Medicines

Drug Information available for:

Zidovudine Abacavir Abacavir sulfate Lamivudine Combivir VX 478

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Safety Study

Official Title:	Combivir, 1592U89, 141W94 Triple Antiretroviral, Experienced Patient Trial

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Detailed Description:

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002217

Locations


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

Sponsors and Collaborators

Glaxo Wellcome

More Information

Publications:

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)

Henry K, Wallace RJ, Bellman PC, Norris D, Fisher RL, Ross LL, Liao Q, Shaefer MS. 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.

Study ID Numbers:	280D, UNAP 12, NZTA 4005
First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002217
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:

Drug Therapy, Combination

Patient Compliance

Anti-HIV Agents

abacavir

Study placed in the following topic categories:

Virus Diseases

Amprenavir

Sexually Transmitted Diseases, Viral

HIV Infections

Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome

Lamivudine

Zidovudine

Abacavir

Retroviridae Infections

Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Anti-Infective Agents

RNA Virus Infections

HIV Protease Inhibitors

Anti-HIV Agents

Slow Virus Diseases

Molecular Mechanisms of Pharmacological Action

Immune System Diseases

Enzyme Inhibitors

Infection

Antiviral Agents

Pharmacologic Actions

Reverse Transcriptase Inhibitors

Antibiotics, Antitubercular

Protease Inhibitors

Anti-Bacterial Agents

Anti-Retroviral Agents

Therapeutic Uses

Lentivirus Infections

Antitubercular Agents

Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on November 20, 2008

Sponsored by:	Glaxo Wellcome
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00002217