TMC278-TiDP6-C130: Pharmacokinetics, Safety and Tolerability of TMC278 in Subjects With Mildly or Moderately Impaired Hepatic Function.

Inclusion Criteria:

• Non smoking or smoking no more than 10 cigarettes, or 2 cigars, or 2 pipes per day for at least 3 months prior to selection
• Body Mass Index (BMI, weight in kg divided by the square of height in meters) of 18.0 to 32.0 kg/m2, extremes included
• Only for subjects with hepatic impairment: History of hepatic disease
• Documented liver cirrhosis
• Mild or moderate liver function impairment
• Only for healthy control subjects: Healthy on the basis of a physical examination, medical history, electrocardiogram (ECG), vital signs and the results of blood biochemistry and hematology tests and a urinalysis
• Matched to a subject with hepatic impairment with regards to sex, age (± 5 yrs), and BMI (± 15%).

Exclusion Criteria:

• No positive HIV test
• No females, except if postmenopausal since more than 2 years, or posthysterectomy, or post tubal ligation
• No barbiturate, amphetamine, recreational or narcotic drug use
• No use of more than 1 unit of alcoholic beverages per day
• No positive urine drug test
• No active gastrointestinal disease (with the exception of liver cirrhosis in the hepatically impaired subjects), cardiovascular, neurologic, psychiatric, metabolic, renal, respiratory, inflammatory, or infectious disease
• No currently significant diarrhea, gastric stasis, or constipation
• No history of any significant skin disease
• No previously demonstrated clinically significant allergy or hypersensitivity to any of the excipients of the investigational medication administered in this trial (i.e. TMC278)
• Not previously participated in more than 1 trial with TMC125, TMC120 and/or TMC278 or having developed a rash, erythema or urticaria while participating in a trial with the aforementioned compounds
• No participation in an investigational drug trial within 60 days prior to the first administration of trial medication
• No donation of blood or plasma or significant blood loss within the 60 days preceding the first administration of trial medication
• No vulnerable subjects
• No subjects who are not able to read or write
• Only for subjects with hepatic impairment: No acute or active hepatitis
• No evidence of hepatic decompensation
• No grade 3 or 4 encephalopathy
• No hepatic carcinoma
• No hepatorenal syndrome
• No severe liver insufficiency
• Not an active candidate for liver transplantation
• No grade 3 laboratory abnormalities present with the exception of laboratory abnormalities related to hepatic impairment
• Only for healthy control subjects: No hepatitis A, B or C infection
• No current hepatic disease
• No subjects with certain lab abnormalities.