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GW640385

Phase 2

Infection, Human Immunodeficiency Virus I | Small molecule | Infectious Disease |GSK plc|Last Updated: May 30, 2017

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment30

FDA Designations

No designations recorded

Clinical trial landscape

GW640385 · 1 trial · 2 indications

Phase 2 1
NCT00257621GW640385 Plus Ritonavir And NRTIs For 48 Weeks In HIV-1 Infected AdultsInfection, Human Immunodeficiency Virus I
COMPLETED30 Analytics
PHASE2COMPLETED
GW640385 Plus Ritonavir And NRTIs For 48 Weeks In HIV-1 Infected Adults
Infection, Human Immunodeficiency Virus I
NCT0025762130
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Study Endpoints

Primary Endpoints

Percentage of subjects with plasma HIV-1 RNA <400 copies/ml. Incidence of serious adverse events, rash and thyroid function abnormalities. GW640385 PK parameters.
throughout the study

Secondary Endpoints

Changes over time in HIV-1 viral load and CD4+ cell counts. Incidence of adverse events and laboratory abnormalities. GW640385 and RTV PK parameters. Development of resistance in subjects with virologic failure.
throughout the study
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Interventions

NameTypeDescription
GW640385DRUG -
RitonavirDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites9

Inclusion criteria: * HIV-1 infected subjects. * Females must be of either non-childbearing potential or have a negative pregnancy test at Screening and agree to use a protocol approved method of contraception. * Plasma HIV-1 RNA (viral load) \>/=1,000 copies/mL at Screening. * CD4+ cell count \>/=...

Countries:United States
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Frequently asked questions about GW640385

What is GW640385 used for?

GW640385 is an investigational small molecule being studied for the treatment of Human Immunodeficiency Virus I (HIV-1) infection. It is being developed as part of a combination regimen for HIV-infected adults.

Who makes GW640385?

GW640385 is being developed by GSK plc, a pharmaceutical company listed on the stock exchange under the ticker symbol GSK.

What phase is GW640385 in?

GW640385 is in Phase 2 clinical development. It has completed one Phase 2 trial and is not yet approved by regulatory authorities, meaning it remains an investigational drug.

What clinical trials is GW640385 in?

GW640385 has been studied in one completed Phase 2 clinical trial, identified as NCT00257621. This trial evaluated GW640385 in combination with ritonavir and nucleoside reverse transcriptase inhibitors (NRTIs) over 48 weeks in HIV-1 infected adults.

Is GW640385 the same as any other drug?

GW640385 is not known to have any alternative names. It is a distinct investigational compound being studied for HIV-1 infection.