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GSK364735

Phase 2

Infection, Human Immunodeficiency Virus | Small molecule | Infectious Disease |GSK plc|Trials Updated: Jul 30, 2012

GSK364735 development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since Nov 2006

GSK364735 target and mechanism

ModalitySmall molecule

Also known as GSK364735

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials2
Total Enrollment86

FDA Designations

No designations recorded

GSK364735 clinical trials

GSK364735 · 2 trials · 3 indications

Phase 2 1Phase 1 1
NCT00398125Monotherapy Versus Placebo Over 10 Days in Integrase Naive HIV-1 Infected AdultsInfection, Human Immunodeficiency Virus
COMPLETED30 Analytics
PHASE2COMPLETED
Monotherapy Versus Placebo Over 10 Days in Integrase Naive HIV-1 Infected Adults
Infection, Human Immunodeficiency VirusUnlock trial analytics

Study Endpoints

Primary Endpoints

Change in viral load
from Day 1 to Day 11
Amount of drug in blood
on Days 1 and 10.
Part 1: PK parameters Day 1: AUC(0-t), AUC(0-t), Cmax, and C12 and C24 Part 2: PK parameters on Day 6: AUC(0-t), Ct, and Cmax

Secondary Endpoints

Immunologic effect Development of resistance mutations Viral load change and drug levels in semen for a group of patients
throughout the study
Part 1 and 2 safety measures: AE, Clinical labs, con meds, ECGs, and Vital signs Part 1: PK parameters Day 1: tmax, t1/2, tlag and CL/F Part 2: PK parameters Day 1&6: AUC 0-t, AUC 0-infinity, AUC 0-12, Cmax, C12 or C24, tmax, t1/2, CL/F, and tlag.
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
GSK364735DRUG -
GSK364735 oral solution and oral tabletsDRUG -
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites12

Inclusion criteria: * Documented HIV-1 infection with screening viral load between 5000 and 300,000 copies/mL. * Baseline CD4 cell count greater than 100. * Females must be of non-childbearing potential * Not have received antiretroviral therapy in the 12 weeks prior to first dose. Exclusion crite...

Countries:United States
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Frequently asked questions about GSK364735

What is GSK364735?

GSK364735 is an investigational small molecule developed by GSK plc for the treatment of HIV infection, including HIV-1. It was studied as an oral therapy in both solution and tablet formulations. It is not an approved medicine and remains in clinical development.

What is GSK364735 used for in HIV infection?

GSK364735 was studied for the treatment of HIV infection, including HIV-1 infection, in adults. Clinical testing included a monotherapy study in integrase naive HIV-1 infected adults and a formulation and food effect study in healthy subjects. It is investigational and has not been approved for any use.

Who makes GSK364735?

GSK364735 is developed by GSK plc, which trades under the ticker GSK. The company sponsored the clinical studies of the compound, including a Phase 2 monotherapy trial in HIV-1 infected adults and a Phase 1 formulation and food effect study in healthy subjects.

What phase is GSK364735 in?

GSK364735 is in clinical development. The program includes a completed Phase 1 study of formulations and food effect in healthy subjects and a completed Phase 2 monotherapy study in integrase naive HIV-1 infected adults. It is investigational and has not been approved by the FDA.

What clinical trials is GSK364735 in?

GSK364735 has been evaluated in two completed trials: NCT00398125, a Phase 2 monotherapy versus placebo study over 10 days in integrase naive HIV-1 infected adults, and NCT00386347, a Phase 1 study evaluating formulations and food effect in healthy subjects. Both were conducted in the United States.