HIV MedDRA version: 8 Level: PT Classification code 10020161
Conditions
Interventions
Product Name: UK-453,061
Pharmaceutical Form: Powder for oral suspension
Other descriptive name: 5-{[3,5-diethyl-1-(2-hydroxyethyl)-1H- pyrazol-4-yl]oxy}isophthalonitrile
Concentration unit: mg millig
Sponsors
Pfizer Pharma GmbH
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Asymptomatic HIV-1 infected male and patients aged 18-55 years inclusive 2. Weight between 50 and 100kg and within the permitted range for their height using Quetelet's index-weight (kg)/height²(m). The permitted index is between 18-30 3. Patients with virus not containing NNRTI resistant mutations as determined by the VircoGEN virtual phenotyping assay 4. No previous exposure to any NNRTIs 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: 1. Patients who on direct questioning and physical examination have any history of convulsions or 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 >2ULN and albumin <LLN) 10. Patients who are taking, or have taken, any prescribed or over the counter (with the exception of paracetamol (up to 3g per day), multivitamins and minerals) drugs in the three weeks prior to the first dose of study medication, except those approved by the Pfizer CPM 11. Patients with a history of severe drug hypersensitivity reactions 12. Patients who drink more than 28 units of alcohol per week (1 unit = 1/2 pint of beer [285mls] or 25ml of spirits or 1 glass of wine [125 mls]) 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 NNRTI
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Investigate the effects of 7-day monotherapy of UK-453,061 on viral load response in asymptomatic HIV infected patients and to assess the dose-response relationship. Assess the pharmacokinetics, safety and tolerability of UK-453,061 in asymptomatic HIV infected patients.;Secondary Objective: ;Primary end point(s): HIV viral load | — |
Countries
Germany
Outcome results
None listed