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Tucaresol

Phase 2

HIV Infection | Small molecule | Infectious Disease |GSK plc|Trials Updated: Oct 13, 2008

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment45

FDA Designations

No designations recorded

Tucaresol clinical trials

Tucaresol · 1 trial · 1 indication

Phase 2 1
NCT00343941Tucaresol As Add-On To HAART (Highly Active Antiretroviral Therapy) In Chronic HIV-1 Infected AdultsHIV Infection
COMPLETED45 Analytics
PHASE2COMPLETED
Tucaresol As Add-On To HAART (Highly Active Antiretroviral Therapy) In Chronic HIV-1 Infected Adults
HIV InfectionUnlock trial analytics

Study Endpoints

Primary Endpoints

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 Endpoints

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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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
Tucaresol tablets 25 mgDRUG -
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Eligibility Criteria

Age Range18 Years to 64 Years
SexALL
Healthy VolunteersNo
Study Sites7

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...

Countries:Italy
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Frequently asked questions about Tucaresol

What is Tucaresol used for?

Tucaresol is an investigational small molecule studied as an add-on to highly active antiretroviral therapy (HAART) in adults with chronic HIV-1 infection. It is not approved for any indication and remains in clinical development. The only recorded trial enrolled 45 adults aged 18 and older in Italy.

Who is developing Tucaresol?

Tucaresol is being developed by GSK plc, which trades under the ticker GSK. The company sponsored the Phase 2 study of Tucaresol as an add-on to HAART in chronic HIV-1 infected adults.

What phase is Tucaresol in?

Tucaresol is in Phase 2 development for HIV infection. It is an investigational small molecule and is not FDA approved. One Phase 2 trial has been completed, and no trials are currently active.

What clinical trials is Tucaresol in?

Tucaresol has been studied in one completed Phase 2 trial, NCT00343941, titled Tucaresol As Add-On To HAART (Highly Active Antiretroviral Therapy) In Chronic HIV-1 Infected Adults. The trial enrolled 45 participants in Italy, was randomized and double blind, and used an uncontrolled design.