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

Primary Purpose

HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lamivudine/Zidovudine
Abacavir sulfate
Amprenavir
Sponsored by
Glaxo Wellcome
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Drug Therapy, Combination, Patient Compliance, Anti-HIV Agents, abacavir

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Anderson Clinical Research

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Glaxo Wellcome
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1. Study Identification

Unique Protocol Identification Number
NCT00002217
Brief Title
A Study of Combivir Plus Abacavir Plus 141W94 in Patients Who Previously Have Used Anti-HIV Drugs
Official Title
Combivir, 1592U89, 141W94 Triple Antiretroviral, Experienced Patient Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 1999
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Glaxo Wellcome

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Drug Therapy, Combination, Patient Compliance, Anti-HIV Agents, abacavir

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Lamivudine/Zidovudine
Intervention Type
Drug
Intervention Name(s)
Abacavir sulfate
Intervention Type
Drug
Intervention Name(s)
Amprenavir

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Anderson Clinical Research
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

Citations:
Citation
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)
Results Reference
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PubMed Identifier
11170982
Citation
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.
Results Reference
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A Study of Combivir Plus Abacavir Plus 141W94 in Patients Who Previously Have Used Anti-HIV Drugs

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