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

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00495677
• Other study ID #: A7691009
• Status: Completed
• Phase: Phase 2
• First received: June 29, 2007
• Last updated: August 26, 2013
• Start date: June 2007
• Est. completion date: September 2008

Study information

• Verified date: August 2013
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV

Intervention

Drug:
• PF-00232798
Solution, 20 mg. once daily, 10 days
• PF-00232798
Solution, 150 mg. once daily, 10 days
• PF-00232798
Solution, 5 mg. once daily, 10 days
• PF-00232798
Solution, 40 mg. once daily, 10 days
• PF-00232798
Solution, 300 mg. once daily, 10 days
• PF-00232798
Solution, 400 mg. once daily, 10 days

Locations

Country	Name	City	State
Germany	Pfizer Investigational Site	Frankfurt am Main
Germany	Pfizer Investigational Site	Koeln

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants With Viral Tropism and Resistance	Virus tropism was determined using the Monogram PhenoSense Entry assay; standard Trofile tropisim assay was used for Stage 1 and enhanced sensitivity Trofile tropisim assay was used for Stage 2.	Screening, pre-dose on Day 1; Day 11, 25	No
Other	Number of Participants With Chemokine Receptor 5 (CCR5) Delta 32 Genotyping and Immunophenotyping	CCR5 Delta 32 genotyping and immunophenotyping was to be done to assess CCR5 Delta 32 status, other CCR5 polymorphisms, enzymes involved in drug metabolism and/or drug transport proteins in order to measure the impact of genetic variation with respect to PF-00232798 in case any unusual patterns of response or an unexplained excess of adverse events occurred.	Pre-dose on Day 1	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No

External Links

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