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

NCT ID: NCT00002390

Last Updated: 2005-06-24

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Brief Summary

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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).

Detailed Description

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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).

Conditions

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HIV Infections

Study Design

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Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Abacavir sulfate

Intervention Type DRUG

Eligibility Criteria

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Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Glaxo Wellcome

INDUSTRY

Sponsor Role lead

Locations

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Group Hospier Pitie-Salpetriere / Maladies Infec et Trop

Paris, , France

Site Status

Groupe Hospitalier Bichat-Claude Bernard

Paris, , France

Site Status

Hopital de Purpan / CHU de Rangueil / Medecine Interue

Toulouse, , France

Site Status

Hopital de Purpan / Service du Professeur Auvergnat

Toulouse, , France

Site Status

Universitat Erlangen

Erlangen, , Germany

Site Status

Universitatsklinikurn Frankfurt

Frankfurt, , Germany

Site Status

Countries

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France Germany

References

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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. doi: 10.1097/00002030-199816000-00001.

Reference Type BACKGROUND
PMID: 9833847 (View on PubMed)

Other Identifiers

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CNAB2002

Identifier Type: -

Identifier Source: secondary_id

238H

Identifier Type: -

Identifier Source: org_study_id