A Study of the Safety & Effectiveness of Different Doses of NCT00002390

Clinical Trial Details — Status: Completed

Administrative data
NCT number	NCT00002390
Other study ID #	238H
Secondary ID	CNAB2002
Status	Completed
Phase	Phase 2
First received	November 2, 1999
Last updated	June 23, 2005

Study information
Verified date	August 1997
Source	NIH AIDS Clinical Trials Information Service
Contact	n/a
Is FDA regulated	No
Health authority	United States: Food and Drug Administration
Study type	Interventional

Clinical Trial Summary

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).

Description:

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).

Recruitment information / eligibility
Status	Completed
Enrollment	0
Est. completion date
Est. primary completion date
Accepts healthy volunteers	No
Gender	Both
Age group	18 Years and older
Eligibility

Study Design

Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

HIV Infections

Intervention

Drug:
• Abacavir sulfate

Locations
Country	Name	City
France	Group Hospier Pitie-Salpetriere / Maladies Infec et Trop	Paris Cedex 13
France	Groupe Hospitalier Bichat-Claude Bernard	Paris Cedex 18
France	Hopital de Purpan / CHU de Rangueil / Medecine Interue	Toulouse Cedex
France	Hopital de Purpan / Service du Professeur Auvergnat	Toulouse Cedex
Germany	Universitat Erlangen	Erlangen
Germany	Universitatsklinikurn Frankfurt	Frankfurt

Sponsors *(1)*
Lead Sponsor	Collaborator
Glaxo Wellcome

Countries where clinical trial is conducted

France, Germany,

References & Publications (1)

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. — View Citation

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

Clinical Trial Details — Status: Completed

Administrative data

Study information