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HIV CTL MEP 1000 micrograms, 19 months per subject

Phase 1

HIV Infections | Monoclonal antibody | Infectious Disease |Pfizer, Inc.|Last Updated: Dec 5, 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 Enrollment60
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00195234Study Evaluating Vaccine in Adults With HIVPHASE1 COMPLETED 60Dec 1, 2004Feb 1, 2007Dec 5, 200710 United States
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Study Endpoints
Primary Endpoints
To evaluate the safety and tolerability of the HIV CTL MEP vaccine formulated with adjuvants, administered by intramuscular (IM) injection to HIV Pos adults receiving stable HAART. Subjects will receive vaccinations at months 0, 1, 3, and 6.
Secondary Endpoints
To evaluate the subject immune system responds to the vaccinations. To evaluate RNA and protein patterns in the collected blood samples after vaccination.
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
HIV CTL MEP 1000 micrograms, 19 months per subjectBIOLOGICAL -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites10

Inclusion Criteria: * 18 years of age diagnosed with HIV and on stable HAART for a minimum of six months * CD4 T-cell count greater than and equal to 350/mm3 at screening * No reported CD4 T-cell count less than 350/mm3 at any time before screening * Viral load less than 50 copies/mL at screening a...

Countries:United States
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