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Tucaresol As Add-On To HAART (Highly Active Antiretroviral Therapy) In Chronic HIV-1 Infected Adults

NCT ID: NCT00343941

Last Updated: 2008-10-13

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

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Brief Summary

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This is a pilot study designed to determine a dose and schedule of Tucaresol that can be administered to HIV-1 infected subjects on HAART (highly active antiretroviral therapy) with viral suppression without occurrence of significant adverse events and that results in significant changes in cell mediated immunity.

Detailed Description

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Conditions

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HIV Infection

Keywords

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HIV-1 infection Tucaresol Viral suppression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Tucaresol tablets 25 mg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Currently on licensed triple combination therapy, which is defined as two nucleoside analogues (2 NRTI) (excluding Abacavir) and a protease inhibitor (PI) (including boosted PI regimens) or non nucleoside reverse transcriptase inhibitor (NNRTI).
* Must be on the same treatment for at least 3 months prior to study without plans to alter therapy for the next 3 months.

Plasma HIV-1 RNA (ribonucleic acid)\< 50 copies/mL at screening with a documented history of continuous suppression defined as: the last two readings \< 50 copies/mL for a period of at least 3 months prior to screening.

* Documented CD4+ lymphocyte cell count =350 cells/ml at screening with at least one reading =350 cells/mL in the preceding 3 months and CD4 nadir \>200 cells/ml.

HBsAg (human hepatitis B Virus surface antigen) and HCV-Ab (human hepatitis C Virus antibody) negative.

Exclusion Criteria

* History of hyperimmune or allergic reactions to drug treatment within 3 months prior to study.
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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GSK

Principal Investigators

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GSK Clinical Trials, MD

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Bergamo, Lombardy, Italy

Site Status

GSK Investigational Site

Busto Arsizio (VA), Lombardy, Italy

Site Status

GSK Investigational Site

Milan, Lombardy, Italy

Site Status

GSK Investigational Site

Milan, Lombardy, Italy

Site Status

GSK Investigational Site

Bagno A Ripoli (FI), Tuscany, Italy

Site Status

GSK Investigational Site

Florence, Tuscany, Italy

Site Status

GSK Investigational Site

Padua, Veneto, Italy

Site Status

Countries

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Italy

Other Identifiers

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100438

Identifier Type: -

Identifier Source: org_study_id