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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00343941
First received: June 22, 2006
Last updated: October 9, 2008
Last verified: October 2008
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


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.

Estimated Enrollment: 45
Study Start Date: November 2004
Intervention Details:
    Drug: Tucaresol tablets 25 mg
    Other Name: Tucaresol tablets 25 mg
  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
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
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, 20157
GSK Investigational Site
Milano, Lombardia, Italy, 20127
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

No publications provided

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
Health Authority: Italy: Ministry of Health

Keywords provided by GlaxoSmithKline:
HIV-1 infection
Tucaresol
Viral suppression

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

ClinicalTrials.gov processed this record on November 27, 2014