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capravirine

Phase 2

HIV Infections | Small molecule | Infectious Disease |Pfizer, Inc.|Last Updated: Oct 10, 2007

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment300
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00052117Four-Drug Combination Treatment in Hiv-Infected Subjects Failing Therapy With Antiretroviral RegimensPHASE2 COMPLETED 300Jan 1, 2003May 1, 2005Oct 10, 2007 -
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Study Endpoints
Primary Endpoints
To determine the optimal safe and effective dose of capravirine in combination with Kaletra plus at least 2 NRTIs
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 — 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...

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