Tucaresol As Add-On To HAART (Highly Active Antiretroviral Therapy) In Chronic HIV-1 Infected Adults
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
1 other identifier
interventional
45
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2004
CompletedFirst Submitted
Initial submission to the registry
June 22, 2006
CompletedFirst Posted
Study publicly available on registry
June 23, 2006
CompletedOctober 13, 2008
October 1, 2008
June 22, 2006
October 9, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (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 Outcomes (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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- History of hyperimmune or allergic reactions to drug treatment within 3 months prior to study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (7)
GSK Investigational Site
Bergamo, Lombardy, 24128, Italy
GSK Investigational Site
Busto Arsizio (VA), Lombardy, 21052, Italy
GSK Investigational Site
Milan, Lombardy, 20127, Italy
GSK Investigational Site
Milan, Lombardy, 20157, Italy
GSK Investigational Site
Bagno A Ripoli (FI), Tuscany, 50126, Italy
GSK Investigational Site
Florence, Tuscany, 50139, Italy
GSK Investigational Site
Padua, Veneto, 35128, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials, MD
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 22, 2006
First Posted
June 23, 2006
Study Start
November 1, 2004
Last Updated
October 13, 2008
Record last verified: 2008-10