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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00343941
Recruitment Status : Completed
First Posted : June 23, 2006
Last Update Posted : October 13, 2008
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Brief Summary:
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 or disease Intervention/treatment Phase
HIV Infection Drug: Tucaresol tablets 25 mg Phase 2

Study Type : Interventional  (Clinical Trial)
Enrollment : 45 participants
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
Study Start Date : November 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Primary Outcome Measures :
  1. 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 :
  1. 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.

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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00343941

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
Study Director: GSK Clinical Trials, MD GlaxoSmithKline

Responsible Party: Study Director, GSK Identifier: NCT00343941     History of Changes
Other Study ID Numbers: 100438
First Posted: June 23, 2006    Key Record Dates
Last Update Posted: October 13, 2008
Last Verified: October 2008

Keywords provided by GlaxoSmithKline:
HIV-1 infection
Viral suppression

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases