A Study of the Safety and Effectiveness of Different Doses of 1592U89 in HIV-Infected Patients

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002390
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: August 1997

November 2, 1999
June 23, 2005
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Complete list of historical versions of study NCT00002390 on ClinicalTrials.gov Archive Site
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A Study of the Safety and Effectiveness of Different Doses of 1592U89 in HIV-Infected Patients
A Phase II Randomized, Blinded, Dose-Ranging Multicenter Study to Evaluate the Safety and Efficacy of Different Regimens of 1592U89 Monotherapy Upon Selected Immunological and Virological Markers of HIV-1 Infection in Antiretroviral Therapy-Naive Patients

The purpose of this study is to see if giving 1592U89 to HIV-infected patients is safe and effective in lowering viral load (level of HIV in the blood) and raising the level of CD4 cells (cells of the body that help fight infection).

Patients are randomized to receive one of three doses of 1592U89. During this randomized dosing phase, if a patient meets one of the following criteria, he/she is offered open-label 1592U89 (300 mg) plus zidovudine (ZDV) plus lamivudine (3TC) (or other licensed antiretrovirals according to standard practice). Criteria are based on falling CD4 counts (return to baseline on two occasions at least 1 month apart), disease progression (defined as occurrence of a new AIDS-defining event according to CDC classification excluding CD4 counts less than 200 cells/mm3), or lack of virus suppression (defined as less than 0.7log10 reduction in viral load at Week 4 with a repeat value 1 week later, more than 5000 copies/ml HIV RNA at Weeks 12, 16, 20, or 24, or 5000 copies/ml or more anytime after Week 24).

Interventional
Phase 2
Masking: Double-Blind
Primary Purpose: Treatment
HIV Infections
Drug: Abacavir sulfate
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Staszewski S, Katlama C, Harrer T, Massip P, Yeni P, Cutrell A, Tortell SM, Harrigan RP, Steel H, Lanier RE, Pearce G. A dose-ranging study to evaluate the safety and efficacy of abacavir alone or in combination with zidovudine and lamivudine in antiretroviral treatment-naive subjects. AIDS. 1998 Nov 12;12(16):F197-202.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France,   Germany
 
NCT00002390
238H, CNAB2002
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Glaxo Wellcome
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NIH AIDS Clinical Trials Information Service
August 1997

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP