Determining if ingestion of silybum marianum (milk thistle) influences the metabolisation of indinavir in healthy subjects: a randomised controlled phase I study

INTERVENTION: Milk thistle (silybum marianum) and indinavir. Twenty‐four healthy male participants: All individuals will receive a HIV test and Liver Function Tests (LFTs ‐ aspartate aminotransferase [AST], alanine aminotransferase [ALT], gamma‐glutamyl transferase [GGT]) to exclude HIV and liver disease, and also a Complete Blood Count (CBC). Subjects are requested to discontinue all medications, alcohol, caffeine, nicotine and other known CYP 3A4 inducers and inhibitors. Informed consent will be obtained from all participants. CONDITION: Drug interactions ; Not Applicable PRIMARY OUTCOME: Not provided at time of registration SECONDARY OUTCOME: Not provided at time of registration INCLUSION CRITERIA: 1. Documented Enzyme‐Linked Immunosorbent Assay (ELISA) and Western Blot results negative for Human Immunodeficiency Virus (HIV) 2. Aged 18 ‐ 35 years 3. Sex male, race Caucasian, and normal findings of laboratory and physical examinations