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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002217
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: May 1999
  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

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Masking: Open Label
Primary Purpose: Treatment
Official Title: Combivir, 1592U89, 141W94 Triple Antiretroviral, Experienced Patient Trial

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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)

ClinicalTrials.gov Identifier: NCT00002217     History of Changes
Other Study ID Numbers: 280D, UNAP 12, NZTA 4005
Study First Received: November 2, 1999
Last Updated: June 23, 2005
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

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Zidovudine
Lamivudine
Abacavir
Lamivudine, zidovudine drug combination
Amprenavir
Anti-HIV Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Antibiotics, Antitubercular
Anti-Bacterial Agents
Antitubercular Agents

ClinicalTrials.gov processed this record on July 26, 2014