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Tucaresol

Phase 2

HIV Infection | Small molecule | Infectious Disease |GSK plc|Last 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

Clinical trial landscape

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 being studied for the treatment of HIV Infection. It is being evaluated as an add-on therapy to highly active antiretroviral therapy (HAART) in adults with chronic HIV-1 infection. The drug is currently in Phase 2 clinical development.

Who makes Tucaresol?

Tucaresol is being developed by GSK plc, a global biopharmaceutical company. GSK is listed on the stock exchange under the ticker symbol GSK. The company is conducting clinical trials to evaluate the safety and efficacy of Tucaresol in patients with HIV infection.

What phase is Tucaresol in?

Tucaresol is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials. The drug is being evaluated for its potential use in treating HIV infection.

What clinical trials is Tucaresol in?

Tucaresol has been studied in one clinical trial, identified as NCT00343941. This Phase 2 trial, titled 'Tucaresol As Add-On To HAART (Highly Active Antiretroviral Therapy) In Chronic HIV-1 Infected Adults', was a randomized, double-blind study that has been completed. The trial enrolled 45 participants in Italy.

Is Tucaresol the same as any other drug?

Tucaresol is the primary name for this investigational drug. No alternative names have been reported for this compound. It is being developed by GSK plc and is currently in Phase 2 clinical trials for the treatment of HIV infection.