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GSK364735

Phase 2

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment30

FDA Designations

No designations recorded

Clinical trial landscape

GSK364735 · 1 trial · 2 indications

Phase 2 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.

Secondary Endpoints

Immunologic effect Development of resistance mutations Viral load change and drug levels in semen for a group of patients
throughout the study
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
GSK364735DRUG -
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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 used for?

GSK364735 is an investigational small molecule being developed for the treatment of HIV infection, including HIV-1 infection. It is being studied in adults with HIV who have not previously been treated with integrase inhibitors. The drug is currently in clinical development and is not approved by the FDA.

What does GSK364735 target?

GSK364735 is being studied as a monotherapy in integrase-naive HIV-1 infected adults, indicating it targets the HIV integrase enzyme. By inhibiting integrase, the drug aims to block viral DNA integration into host cells, thereby reducing viral replication. This mechanism is being evaluated in clinical trials.

Who makes GSK364735?

GSK364735 is being developed by GSK plc, a global biopharmaceutical company listed on the stock exchange under the ticker GSK. The company is conducting clinical trials to evaluate the drug's safety and efficacy in treating HIV infection.

What phase is GSK364735 in?

GSK364735 is in Phase 2 clinical development. It has completed a Phase 1 study in healthy subjects and a Phase 2 study in HIV-1 infected adults. The drug is investigational and has not received FDA approval. Its development status is based on completed trials.

What clinical trials is GSK364735 in?

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

Is GSK364735 the same as another drug?

GSK364735 is not known to have alternative names. It is identified by its compound number in clinical trials and is being developed solely by GSK plc. No other names or aliases have been associated with this drug in the available clinical trial information.