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Clinical Trials

MainTitle

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

This study has been completed
Sponsor
GlaxoSmithKline


Information provided by (Responsible Party)
GlaxoSmithKline
ClinicalTrials.gov Identifier
NCT00343941

First received: June 22, 2006
Last updated: October 9, 2008
Last Verified: October 2008
History of Changes
Purpose

Purpose

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.

Condition Intervention Phase
HIV Infection

Drug : Tucaresol tablets 25 mg
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Phase II Multicentre, Randomized, Double Blind, Parallel Group, Placebo Controlled Pilot Study of Tucaresol at Two Dosing Levels (25,50 mg) in HIV-1 Infected Adult Subjects With Plasma HIV-1 RNA < 50 Copies/ml on Stable Highly Active Antiretroviral Therapy Regimen for at Least 3 Months

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures

  • Significant increase from baseline in IFN-g (Interferon gamma) EliSpot cellular responses at day 70 following peptide stimulation of PBMC (peripheral blood monocytic cells) of subjects after the second dosing cycle of study drug (days 56 to 62).
Secondary Outcome Measures:
  • Proportion of subjects developing drug related and treatment-limiting Adverse Events leading to discontinuation of study drug during the period of study and follow-up.

Enrollment: 45
Study Start Date: November 2004

Eligibility

Eligibility

Ages Eligible for Study: 18 Years to 64 Years  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

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.

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00343941

Locations

Italy
GSK Investigational Site
Bergamo, Lombardia, Italy, 24128
GSK Investigational Site
Busto Arsizio (VA), Lombardia, Italy, 21052
GSK Investigational Site
Milano, Lombardia, Italy, 20127
GSK Investigational Site
Milano, Lombardia, Italy, 20157
GSK Investigational Site
Bagno a Ripoli (FI), Toscana, Italy, 50126
GSK Investigational Site
Firenze, Toscana, Italy, 50139
GSK Investigational Site
Padova, Veneto, Italy, 35128

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director: GSK Clinical Trials, MD GlaxoSmithKline
More Information

More Information


Responsible Party: Study Director, GSK  
ClinicalTrials.gov Identifier: NCT00343941   History of Changes  
Other Study ID Numbers: 100438  
Study First Received: June 22, 2006  
Last Updated: October 9, 2008  

Keywords provided by GlaxoSmithKline:

HIV-1 infection
Tucaresol
Viral suppression

Additional relevant MeSH terms:
HIV Infections

ClinicalTrials.gov processed this data on October 23, 2017
This information is provided by ClinicalTrials.gov.