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
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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COMPLETED
NA
INTERVENTIONAL
Brief Summary
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Detailed Description
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Conditions
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Study Design
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TREATMENT
NONE
Interventions
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Lamivudine/Zidovudine
Abacavir sulfate
Amprenavir
Eligibility Criteria
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Inclusion Criteria
* 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
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.
18 Years
ALL
No
Sponsors
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Glaxo Wellcome
INDUSTRY
Locations
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Anderson Clinical Research
Pittsburgh, Pennsylvania, United States
Countries
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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)
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.
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