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GW810781

Phase 2

HIV Infections | Small molecule | Infectious Disease |GSK plc|Last Updated: Feb 21, 2013

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment100

FDA Designations

No designations recorded

Clinical trial landscape

GW810781 · 1 trial · 1 indication

Phase 2 1
NCT00046332A Study Comparing 4 Doses Of GW810781 Versus Placebo In HIV-Infected PatientsHIV Infections
COMPLETED100 Analytics
PHASE2COMPLETED
A Study Comparing 4 Doses Of GW810781 Versus Placebo In HIV-Infected Patients
HIV InfectionsUnlock trial analytics

Study Endpoints

Primary Endpoints

Plasma HIV-1 RNA change from baseline by Day 11.

Secondary Endpoints

HIV-1 RNA slope over 11 days; proportion of subjects with treatment-limiting adverse events; change from baseline in CD4+ cell count at Day 11; plasma pharmacokinetics by dose; emergence of viral resistance.
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
GW810781DRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites23

Inclusion Criteria: * No prior HIV medications. * HIV infection with viral load \>400-50,000 copies/mL. * CD4 cell count \>50 cells/mm. Exclusion Criteria: * Patients requiring medications that cannot be interrupted for the duration of the study. * Abnormal ECG or other chronic health conditions ...

Countries:United States
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Frequently asked questions about GW810781

What is GW810781 used for?

GW810781 is an investigational small molecule being studied for the treatment of HIV infections. It is not approved and remains in clinical development.

Who makes GW810781?

GW810781 is being developed by GSK plc, a pharmaceutical company listed on the stock exchange under the ticker GSK.

What phase is GW810781 in?

GW810781 is in Phase 2 clinical development. It has completed one Phase 2 trial and is not yet approved.

What clinical trials is GW810781 in?

GW810781 has one completed Phase 2 trial, NCT00046332, which compared four doses of the drug versus placebo in HIV-infected patients. The trial enrolled 100 participants in the United States.

Is GW810781 FDA approved?

GW810781 is not FDA approved. It is an investigational drug that has completed a Phase 2 trial but remains in clinical development.