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

Phase 2

Completed

• Conditions: HIV
• Interventions: Drug: PF-00232798

• Registration Number: NCT00495677
• Lead Sponsor: Pfizer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2007-06-29
• Study First Submitted QC: 2007-06-29
• Study First Posted: 2007-07-03
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Disposition First Submitted: 2009-03-20
• Disposition First Submitted QC: 2009-09-21
• Disposition First Posted: 2009-09-28
• Status Verified: 2013-08
• Results First Submitted: 2013-08-26
• Results First Submitted QC: 2013-08-26
• Last Update Submitted: 2013-08-26
• Results First Posted: 2013-10-30
• Last Update Posted: 2013-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 43

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PF-00232798 300 mg	PF-00232798	-
PF-00232798 400 mg	PF-00232798	-
PF-00232798 40 mg	PF-00232798	-
PF-00232798 150 mg	PF-00232798	-
PF-00232798 20 mg	PF-00232798	-
PF-00232798 5 mg	PF-00232798	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)	0 hour (pre-dose), 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 10	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).
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
Number of Participants With Time to Rebound of Human Immunodeficiency Virus (HIV) Viral Load	Day 1 up to Day 25	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.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇩🇪 Koeln, Germany