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

Study Overview
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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.

Official Title
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A Randomised, Double-Blind, Placebo-Controlled, Multicentre Study In Asymptomatic Hiv-Infected Patients To Investigate The Pharmacodynamics, Pharmacokinetics, Safety And Toleration Of PF-00232798

Conditions
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HIV

Intervention / Treatment
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* Drug: PF-00232798
* Drug: PF-00232798
* Drug: PF-00232798
* Drug: PF-00232798
* Drug: PF-00232798
* Drug: PF-00232798


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PF-00232798 40 mg<br> | Drug: PF-00232798<br>* Solution, 40 mg. once daily, 10 days<br>|
| Active Comparator: PF-00232798 300 mg<br> | Drug: PF-00232798<br>* Solution, 300 mg. once daily, 10 days<br>|
| Active Comparator: PF-00232798 400 mg<br> | Drug: PF-00232798<br>* Solution, 400 mg. once daily, 10 days<br>|
| Active Comparator: PF-00232798 5 mg<br> | Drug: PF-00232798<br>* Solution, 5 mg. once daily, 10 days<br>|
| Active Comparator: PF-00232798 20 mg<br> | Drug: PF-00232798<br>* Solution, 20 mg. once daily, 10 days<br>|
| Active Comparator: PF-00232798 150 mg<br> | Drug: PF-00232798<br>* Solution, 150 mg. once daily, 10 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline, Day 11 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 
| 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). | 0 hour (pre-dose), 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 10 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Treatment Experienced, Treatment Naive