Randomised controlled trial of the tolerability and completion of maraviroc compared to Kaletra© in combination with Truvada© for HIV post-exposure prophylaxis - Maraviroc in HIV post exposure prophylaxis (MiPEP) Trial Version 1.0

Camden Provider Services0 个研究点目标入组 213 人开始时间: 2012年1月4日最近更新: 2019年6月30日

适应症

试验速览

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•1. A patient attending one of four genitourinary medicine clinics and for whom PEP is considered appropriate by the clinician according to current guidelines including following occupational or non occupational exposure. 2. Willing to provide written informed consent. 3. 18 years old or older.
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 250
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 30

•1. The baseline HIV test is reactive or positive 2. Currently receiving medication which would reduce the effectiveness of Kaletra / maraviroc (see appendix 1) 3. Currently receiving medication where the interaction would result in a dangerously high level of the concomitant drug (see appendix 1) 4. Pregnant or trying to become pregnant at the time of trial entry. 5. The source is known to have multi-drug resistant HIV and therefore more likely to have CXCR 4 tropic virus 6. History of active substance abuse or psychiatric illness that, in the opinion of the investigator, would preclude compliance with the protocol, dosing schedule or assessments. 7. Any other active clinically significant condition, or findings during screening medical history or examination, or abnormality on screening laboratory blood tests that would, in the opinion of the investigator, compromise the patient’s safety or outcome in the trial.

发起方

Camden Provider Services