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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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HIV Infection

Intervention / Treatment
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* Drug: Tucaresol tablets 25 mg


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Tucaresol tablets 25 mg|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV-1 infection, Tucaresol, Viral suppression