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Capravirine

Phase 2

Human Immunodeficiency Virus | Small molecule | Infectious Disease |Pfizer, Inc.|Last Updated: May 10, 2011

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment179

FDA Designations

No designations recorded

Clinical trial landscape

Capravirine · 2 trials · 2 indications

Phase 2 2
NCT00052117Four-Drug Combination Treatment in Hiv-Infected Subjects Failing Therapy With Antiretroviral RegimensHIV Infections
COMPLETED300 Analytics
NCT00051844Capravirine (AG1549) in Combination With Viracept and Two NRTIs in HIV Infected Patients Who Failed an Initial NNRTI Containing RegimenHuman Immunodeficiency Virus
COMPLETED179 Analytics
PHASE2COMPLETED
Four-Drug Combination Treatment in Hiv-Infected Subjects Failing Therapy With Antiretroviral Regimens
HIV InfectionsUnlock trial analytics
PHASE2COMPLETED
Capravirine (AG1549) in Combination With Viracept and Two NRTIs in HIV Infected Patients Who Failed an Initial NNRTI Containing Regimen
Human Immunodeficiency VirusUnlock trial analytics

Study Endpoints

Primary Endpoints

To determine the optimal safe and effective dose of capravirine in combination with Kaletra plus at least 2 NRTIs
The primary objective was to determine whether the addition of capravirine to a regimen of VIRACEPT and 2 new nucleoside reverse transcriptase inhibitors would provide a higher virologic response rate over 48 weeks
when compared to a 3-drug regimen without capravirine in patients who had experienced virologic failure while on a nonnucleoside reverse transcriptase inhibitor regimen.

Secondary Endpoints

the relationship of HIV baseline resistance (genotype and phenotype) to virologic outcome
the population pharmacokinetics of capravirine and lopinavir/ritonavir (Kaletra) using mixed-effects modeling
the pharmacokinetic drug-drug interactions between capravirine and Kaletra and selected concomitant medications
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
capravirineDRUG -
KaletraDRUG -
2 NRTIsDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * HIV-infected male or female at least 18 years of age * HIV RNA level \>1000 copies/mL at screening * Subject has failed regimens that included at least 1 protease inhibitor but not more than 3 protease inhibitors, at least 1 nonnucleoside reverse transcriptase inhibitor, and l...

Countries:United StatesFranceGermanyItalySouth AfricaSpain
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Frequently asked questions about Capravirine

What is Capravirine used for?

Capravirine is an investigational small molecule being developed for the treatment of HIV Infections and Human Immunodeficiency Virus. It is intended for use in HIV infected patients, including those who have failed an initial NNRTI containing regimen. The drug is currently in Phase 2 clinical development.

Who makes Capravirine?

Capravirine is being developed by Pfizer, Inc., which is publicly traded under the ticker symbol PFE. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with HIV infections.

What phase is Capravirine in?

Capravirine is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials to determine its safety and effectiveness for treating HIV infections.

What clinical trials is Capravirine in?

Capravirine has been studied in two completed Phase 2 clinical trials. One trial, NCT00051844, evaluated Capravirine in combination with Viracept and two NRTIs in HIV infected patients who failed an initial NNRTI containing regimen. Another trial, NCT00052117, studied a four-drug combination treatment in HIV infected subjects failing therapy.

Is Capravirine the same as AG1549?

Capravirine is also known as AG1549. The clinical trial NCT00051844 refers to Capravirine as AG1549 in its title, confirming that these names refer to the same investigational drug being developed by Pfizer for the treatment of HIV infections.