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PF-00232798

Phase 2

HIV | Small molecule | Infectious Disease |Pfizer, Inc.|Trials Updated: Oct 30, 2013

PF-00232798 development status

Highest phase Phase 2
Registered trials 2 across 1 sponsor since Jul 2007

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment43

FDA Designations

No designations recorded

PF-00232798 clinical trials

PF-00232798 · 1 trial · 1 indication

Phase 2 1
NCT00495677A Phase 2 Study Of PF-00232798 In HIV Positive PatientsHIV
COMPLETED43 Analytics
PHASE2COMPLETED
A Phase 2 Study Of PF-00232798 In HIV Positive Patients
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Study Endpoints

Primary Endpoints

Change From Baseline in Log 10-transformed Human Immunodeficiency Virus (HIV) Viral Load at Day 11
Baseline, Day 11

Viral load was determined using the Roche COBAS Taqman HIV-1 assay with a lower limit of detection of 40 copies per milliliter (copies/mL). Samples with an initial reading of less than 1,000,000 copies/mL were diluted into range and re-assayed.

Secondary Endpoints

Number of Participants With Time to Rebound of Human Immunodeficiency Virus (HIV) Viral Load
Day 1 up to Day 25
Maximum Observed Plasma Concentration (Cmax)
0 hour (pre-dose) on Day 1 to 9; 0 hour (pre-dose), 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 10; Day 12, 13, 15 morning
Time to Reach Maximum Observed Plasma Concentration (Tmax)
0 hour (pre-dose) on Day 1 to 9; 0 hour (pre-dose), 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 10; Day 12, 13, 15 morning
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PF-00232798 40 mgACTIVE_COMPARATOR -
PF-00232798 300 mgACTIVE_COMPARATOR -
PF-00232798 400 mgACTIVE_COMPARATOR -
PF-00232798 5 mgACTIVE_COMPARATOR -
PF-00232798 20 mgACTIVE_COMPARATOR -
PF-00232798 150 mgACTIVE_COMPARATOR -

Interventions

NameTypeDescription
PF-00232798DRUGSolution, 20 mg. once daily, 10 days
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Eligibility Criteria

Age Range18 Years to 55 Years
SexMALE
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Asymptomatic HIV-1 infected male patients between the ages of 18 and 55 years inclusive. * Patients with CCR5 tropic virus as determined by the Monogram PhenoSense Entry assay. Exclusion Criteria: * Patients who have received any experimental drug within the past four months...

Countries:Germany
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Frequently asked questions about PF-00232798

What is PF-00232798?

PF-00232798 is an investigational small molecule drug that Pfizer developed for the treatment of HIV. It was studied as a Phase 2 candidate in HIV positive patients. It is not an approved medicine and no longer appears to be in active clinical development.

What is PF-00232798 used for?

PF-00232798 was studied for the treatment of HIV infection. Its only recorded clinical trial enrolled HIV positive adult patients in Germany. The drug is investigational and has not been approved for any use.

Who makes PF-00232798?

PF-00232798 was developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer sponsored the Phase 2 HIV study of the compound.

What phase is PF-00232798 in?

PF-00232798 reached Phase 2 clinical development for HIV. That Phase 2 trial has been completed, and the drug is not currently listed as being in an active trial. It is an investigational agent and is not FDA approved.

What clinical trials is PF-00232798 in?

PF-00232798 was evaluated in one clinical trial, NCT00495677, titled A Phase 2 Study Of PF-00232798 In HIV Positive Patients. The completed study enrolled 43 participants in Germany and used a randomized, double-blind, active-controlled design.