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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2008-09-30

Brief Summary

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

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Detailed Description

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Conditions

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HIV

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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PF-00232798 40 mg

Group Type ACTIVE_COMPARATOR

PF-00232798

Intervention Type DRUG

Solution, 40 mg. once daily, 10 days

PF-00232798 300 mg

Group Type ACTIVE_COMPARATOR

PF-00232798

Intervention Type DRUG

Solution, 300 mg. once daily, 10 days

PF-00232798 400 mg

Group Type ACTIVE_COMPARATOR

PF-00232798

Intervention Type DRUG

Solution, 400 mg. once daily, 10 days

PF-00232798 5 mg

Group Type ACTIVE_COMPARATOR

PF-00232798

Intervention Type DRUG

Solution, 5 mg. once daily, 10 days

PF-00232798 20 mg

Group Type ACTIVE_COMPARATOR

PF-00232798

Intervention Type DRUG

Solution, 20 mg. once daily, 10 days

PF-00232798 150 mg

Group Type ACTIVE_COMPARATOR

PF-00232798

Intervention Type DRUG

Solution, 150 mg. once daily, 10 days

Interventions

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PF-00232798

Solution, 20 mg. once daily, 10 days

Intervention Type DRUG

PF-00232798

Solution, 150 mg. once daily, 10 days

Intervention Type DRUG

PF-00232798

Solution, 5 mg. once daily, 10 days

Intervention Type DRUG

PF-00232798

Solution, 40 mg. once daily, 10 days

Intervention Type DRUG

PF-00232798

Solution, 300 mg. once daily, 10 days

Intervention Type DRUG

PF-00232798

Solution, 400 mg. once daily, 10 days

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No