A RANDOMISED, DOUBLE-BLIND (SPONSOR-OPEN), PLACEBO-CONTROLLED, MULTICENTRE STUDY IN ASYMPTOMATIC HIV-INFECTED PATIENTS TO INVESTIGATETHE PHARMACODYNAMICS, PHARMACOKINETICS, SAFETY AND TOLERATION OF PF-00232798 - N/A

Recruitment & Eligibility

Status: ot Recruiting

Sex: Male

Target Recruitment: 44

Inclusion Criteria

Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:
1. Asymptomatic HIV-1 infected male patients between the ages of 18-55 years inclusive.
2. Weight between 50 and 100 kg and within the permitted range for their height using Quetelet's index-weight (kg)/height (m2). The permitted index is between 18-30.
3. Patients with CCR5 tropic virus as determined by the Monogram PhenoSense Entry
assay.
4. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Subjects presenting with any of the following will not be included in the study:
1. Patients who on direct questioning or physical examination have evidence of any
clinically significant disease that in the opinion of the investigator may impact on their
participation in the study.
2. Patients with a CD4 count <250 cells/mm3.
3. Patients whose HIV infection has been diagnosed <3 months prior to screening, or for whom there is evidence of recent seroconversion.
4. Patients with an HIV viral load <5000 copies/mL using the Roche COBAS Taqman HIV 1 assay.
5. Patients with CXCR4 or dual tropic virus as determined by the Monogram recombinant virus entry assay or repeated assay failure.
6. Patients with AIDS or a previous AIDS diagnosis.
7. Patients who are taking, or have taken, antiretroviral drugs in the eight weeks prior to the study screening visit.
8. Any patient, who in the opinion of the investigator, may need treatment with
antiretroviral drugs before the end of the study period.
9. Patients with any clinically significant abnormality following review of pre-study
laboratory data and full physical examination apart from that which would be expected as part of HIV infection. Specifically patients with evidence of hepatic impairment (cut-off values of AST, ALT and AP >2.5 ULN, total bilirubin >1.5 ULN and albumin 10. Patients who are taking, or have taken, any prescribed or over the counter (with the exception of paracetamol (up to 3 g per day), multivitamins and minerals) drugs in the three weeks prior to the first dose of study medication, except those approved by the Pfizer Clinician.
11. Patients with a history of severe drug hypersensitivity reactions.
12. Patients who drink more than 21 units of alcohol per week (1 unit = 150 mL wine,
360 mL beer or 45 mL of spirits).
13. Patients who have a psychological or sociological condition or an addictive disorder that would preclude compliance with the protocol in the opinion of the investigator.
14. 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.
15. Current or past history of QT prolongation or abnormality on ECG, or 12-lead ECG demonstrating QTc>450 msec at screening.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: - Investigate the effects of 10-day monotherapy of PF-00232798 on viral load response in asymptomatic HIV-infected patients and to the assess dose-response relationship.<br>- Assess the pharmacokinetics, safety and tolerability of PF-00232798 in HIV-infected patients.;Secondary Objective: ;Primary end point(s): HIV viral load

Secondary Outcome Measures