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abacavir

Phase 3

HIV Infection | Small molecule | Infectious Disease |GSK plc|Last Updated: Sep 30, 2010

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials2
Total Enrollment930

FDA Designations

No designations recorded

Clinical trial landscape

abacavir · 2 trials · 1 indication

Phase 3 1Phase 1 1
NCT00094367A Study Comparing Safety Of Abacavir And Lamivudine Administered Once-Daily As A Single Tablet Versus The Same Drugs Administered Twice-Daily As Separate Tablets (ALOHA Study)HIV Infection
COMPLETED900 Analytics
PHASE3COMPLETED
A Study Comparing Safety Of Abacavir And Lamivudine Administered Once-Daily As A Single Tablet Versus The Same Drugs Administered Twice-Daily As Separate Tablets (ALOHA Study)
HIV Infection
NCT00094367900
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Study Endpoints

Primary Endpoints

The occurrence of treatment-limiting adverse events after starting study drugs.
To assess the pharmacokinetics of intracellular CBV-TP at steady state following administration of 600 mg QD and 300 mg BID ABC-containing regimens in HIV infected adult subjects.
throughout the study

Secondary Endpoints

occurrence of abacavir HSR
completion of educational training
subject satisfaction with treatment
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
Abacavir/LamivudineDRUG -
abacavirDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites178

Inclusion Criteria: * Have HIV-1 infection. * Had not received any prior HIV treatment for more than 14 days. * At least 1000 copies of HIV-1 RNA. * Willing to provide signed informed consent. Exclusion Criteria: * Enrolled in other investigational drug studies. * Female subjects who are pregnant...

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

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 abacavir

What is abacavir used for?

Abacavir is a small molecule drug being developed by GSK plc for the treatment of Human Immunodeficiency Virus I (HIV-1) infection. It is being studied in antiretroviral therapy experienced HIV-1 infected subjects and in healthy subjects for bioavailability studies. The drug is currently in Phase 3 clinical development.

What does abacavir target?

Abacavir is a nucleoside reverse transcriptase inhibitor (NRTI) that works by inhibiting the reverse transcriptase enzyme of HIV, thereby blocking viral replication. It is used in combination with other antiretroviral agents for the treatment of HIV-1 infection.

Who makes abacavir?

Abacavir is being developed by GSK plc, a pharmaceutical company listed on the stock exchange under the ticker symbol GSK. The company is conducting clinical trials to evaluate the drug's safety and efficacy in treating HIV-1 infection.

What phase is abacavir in?

Abacavir is in Phase 3 clinical development for the treatment of HIV-1 infection. It has completed two Phase 3 trials, NCT00044577 and NCT00046176, which evaluated the drug in antiretroviral therapy experienced HIV-1 infected subjects.

What clinical trials is abacavir in?

Abacavir has been studied in several clinical trials, including two Phase 3 trials: NCT00044577, which enrolled 166 participants in the US, Belgium, Canada, France, Germany, Italy, Portugal, Spain, and the UK, and NCT00046176, which enrolled 240 participants in the US, Costa Rica, Panama, and Puerto Rico. Both trials have been completed.

Is abacavir the same as dolutegravir/abacavir/lamivudine?

Abacavir is a component of a fixed-dose combination tablet containing dolutegravir, abacavir, and lamivudine. A Phase 1 trial, NCT01366547, studied the relative bioavailability of two new dolutegravir/abacavir/lamivudine fixed-dose combination tablets in healthy subjects and HIV-infected individuals.