Human Immunodeficiency Virus (HIV) infection MedDRA version: 9.1 Level: LLT Classification code 10000807 Term: Acute HIV infection
Conditions
Interventions
Product Code: PF-00232798
Pharmaceutical Form: Powder for oral solution
INN or Proposed INN: N/A
CAS Number: 849753-20-4
Current Sponsor code: PF-00232798
Concentration unit: mg milligram(s)
Concentra
Sponsors
Pfizer Inc., 235 East 42nd Street, New York, NY 10017
Eligibility
Sex/Gender
Male
Inclusion criteria
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
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 2.5 ULN, total bilirubin >1.5 ULN and albumin 450 msec at screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. - Assess the pharmacokinetics, safety and tolerability of PF-00232798 in HIV-infected patients.;Secondary Objective: ;Primary end point(s): HIV viral load | — |
Countries
Germany
Outcome results
None listed