A Phase 2 Study Of PF-00232798 In HIV Positive Patients

Pfizer43 enrolled

Overview

To assess the viral load response, safety, tolerability and pharmacokinetics of multiple oral doses of PF 00232798 in HIV-positive patient volunteers.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

HIV

Interventions

PF-00232798DRUG

Solution, 20 mg. once daily, 10 days

PF-00232798DRUG

Solution, 150 mg. once daily, 10 days

PF-00232798DRUG

Solution, 5 mg. once daily, 10 days

PF-00232798

Eligibility

Sex: MALEMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

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 (prior to the first dosing day of the study) or who have previously received another CCR5 antagonist. * Patients with evidence of decompensated liver disease.

Locations (2)

Pfizer Investigational Site

Cologne, Germany

Pfizer Investigational Site

Frankfurt am Main, Germany

Outcomes

Primary Outcomes

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

Time frame: Baseline, Day 11

Secondary Outcomes

Number of Participants With Time to Rebound of Human Immunodeficiency Virus (HIV) Viral Load

The time to rebound of viral load was calculated as the time from the last dose to the time of the first occasion at which the viral load was greater than the baseline value. Results are reported for number of participants who rebound within specified days from last dose and who did not rebound up to Day 25.

Time frame: Day 1 up to Day 25

Maximum Observed Plasma Concentration (Cmax)

Time frame: 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)

Time frame: 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

Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)

AUCtau= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to the time end of dosing interval (24 hours post-dose).

Time frame: 0 hour (pre-dose), 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 10

Data from ClinicalTrials.gov

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