Back to resultsTucaresol As Add-On To HAART (Highly Active Antiretroviral Therapy) In Chronic HIV-1 Infected Adults
Primary Purpose
HIV Infection
Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Tucaresol tablets 25 mg
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infection focused on measuring HIV-1 infection, Tucaresol, Viral suppression
Eligibility 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.
Sites / Locations
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
Outcomes
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00343941
Brief Title
Tucaresol As Add-On To HAART (Highly Active Antiretroviral Therapy) In Chronic HIV-1 Infected Adults
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 Type
Interventional
2. Study Status
Record Verification Date
October 2008
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infection
Keywords
HIV-1 infection, Tucaresol, Viral suppression
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
45 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Tucaresol tablets 25 mg
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials, MD
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Bergamo
State/Province
Lombardia
ZIP/Postal Code
24128
Country
Italy
Facility Name
GSK Investigational Site
City
Busto Arsizio (VA)
State/Province
Lombardia
ZIP/Postal Code
21052
Country
Italy
Facility Name
GSK Investigational Site
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20127
Country
Italy
Facility Name
GSK Investigational Site
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20157
Country
Italy
Facility Name
GSK Investigational Site
City
Bagno a Ripoli (FI)
State/Province
Toscana
ZIP/Postal Code
50126
Country
Italy
Facility Name
GSK Investigational Site
City
Firenze
State/Province
Toscana
ZIP/Postal Code
50139
Country
Italy
Facility Name
GSK Investigational Site
City
Padova
State/Province
Veneto
ZIP/Postal Code
35128
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Tucaresol As Add-On To HAART (Highly Active Antiretroviral Therapy) In Chronic HIV-1 Infected Adults
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