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

Pfizer

Status and phase

Completed

Phase 2

Conditions

HIV

Treatments

Drug: PF-00232798

Study type

Interventional

Funder types

Industry

Identifiers

NCT00495677

A7691009

Details and patient eligibility

About

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

Enrollment

43 patients

Sex

Male

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

43 participants in 6 patient groups

PF-00232798 40 mg

Active Comparator group

Treatment:

Drug: PF-00232798

PF-00232798 300 mg

Active Comparator group

Treatment:

Drug: PF-00232798

PF-00232798 400 mg

Active Comparator group

Treatment:

Drug: PF-00232798

PF-00232798 5 mg

Active Comparator group

Treatment:

Drug: PF-00232798

PF-00232798 20 mg

Active Comparator group

Treatment:

Drug: PF-00232798

PF-00232798 150 mg

Active Comparator group

Treatment:

Drug: PF-00232798

Trial contacts and locations

2

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