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GW695634

Phase 1

HIV Infections | Small molecule | Infectious Disease |GSK plc|Last Updated: Feb 27, 2006

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment50

FDA Designations

No designations recorded

Clinical trial landscape

GW695634 · 1 trial · 1 indication

Phase 1 1
NCT00090077Monotherapy Versus Placebo Over 7 Days-Non-Nucleoside Reverse Transcriptase Inhibitor-Experienced HIV1 Infected AdultsHIV Infections
COMPLETED50 Analytics
PHASE1COMPLETED
Monotherapy Versus Placebo Over 7 Days-Non-Nucleoside Reverse Transcriptase Inhibitor-Experienced HIV1 Infected Adults
HIV Infections
NCT0009007750
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Study Endpoints

Primary Endpoints

Safety & tolerability parameters Change from baseline in plasma HIV-1 RNA Change from baseline in CD4+ cell count Plasma GW678248X pharmacokinetic parameters Days 1 & 7

Secondary Endpoints

Plasma GW695634X pharmacokinetic parameters on Day 1 and Day 7 Exploratory relationship of pharmacokinetic parameters to changes in virology, immunology and/or safety assessments
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
GW695634DRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites18

Inclusion criteria: * CD4 cell count greater than or equal to 200 cells/mm3. * HIV-1 RNA \>2000 copies/mL. * Must have history of NNRTI treatment with subsequent failure and documented evidence of an NNRTI-associated mutation or a phenotype displaying reduced activity to efavirenz, nevirapine or de...

Countries:United States
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Competitive Landscape -Bacterial Infections 61 trials (matched to "HIV Infections")

Top 20 of 28 competitors

CompanyTickerTrialsLead PhaseDrugs
Pfizer Inc.PFE5PHASE3VLA15
Sanofi SA Sponsored ADRSNY2PHASE3PCV21, 20vPCV
GSK plc Sponsored ADRGSK4PHASE2MenABCWY vaccine
Grifols, S.A. Sponsored ADR Class BGRFS1PHASE3Xembify
CorMedix Inc.CRMD2PHASE3catheter lock, Heparin
Sinovac Biotech Ltd.SVA4PHASE3Sinovac PCV13, Prevnar
Novartis AG Sponsored ADRNVS1PHASE2Cryptosporidium parvum oocysts, EDI048
Innoviva, Inc.INVA3PHASE2Eravacycline/kg
BiomX Inc.PHGE1PHASE2BX004
Merck & Co., Inc.MRK2PHASE1V118C, PCV20
ICON PlcICLR1PHASE2AV7909 Full Dose, AV7909 Half Dose
AstraZeneca PLCAZN1PHASE1AZD7760
BioNTech SE Sponsored ADRBNTX1PHASE1BNT163
60 Degrees Pharmaceuticals, Inc.SXTP1PHASE2Tafenoquine
Tarsus Pharmaceuticals, Inc.TARS1PHASE2TP-05 Low Dose
Moderna, Inc.MRNA1PHASE2mRNA-1982
AN2 Therapeutics, Inc.ANTX1PHASE2Epetraborole
Emergent BioSolutions Inc.EBS4 - AIGIV
Abbott LaboratoriesABT1N/AUndisclosed
CareDx, Inc.CDNA1 - Undisclosed
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Frequently asked questions about GW695634

What is GW695634 used for?

GW695634 is an investigational small molecule being studied for the treatment of HIV infections. It is in Phase 1 clinical development and is not yet approved by regulatory authorities.

Who is developing GW695634?

GW695634 is being developed by GSK plc, a biopharmaceutical company listed on the stock exchange under the ticker GSK.

What phase is GW695634 in?

GW695634 is in Phase 1 clinical development. It is an investigational drug and has not been approved for any use.

What clinical trials is GW695634 in?

GW695634 has one completed Phase 1 clinical trial, identified as NCT00090077. This trial was a monotherapy versus placebo study over 7 days in non-nucleoside reverse transcriptase inhibitor-experienced HIV-1 infected adults.

Is GW695634 the same as any other drug?

GW695634 is the primary name for this investigational drug. No alternative names have been established for it.