Tolerability and completion of Maraviroc compared to Kaletra® in combination with Truvada® for HIV Post Exposure Prophylaxis

Phase 4

Completed

• Conditions: HIV; Infections and Infestations

• Registration Number: ISRCTN63350011
• Lead Sponsor: Central and North West London NHS Foundation Trust (UK)

Brief Summary

2017 results in https://www.ncbi.nlm.nih.gov/pubmed/28369381

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-03-09
• Study Completion: 2013-06-01
• Last Update Posted: 26 February 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 280

Inclusion Criteria

1. 18 years old or older
2. 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
3. Willing to provide written informed consent

Exclusion Criteria

1. The baseline human immunodeficiency virus (HIV) test is reactive or positive
2. Currently receiving medication which would reduce the effectiveness of Kaletra® / maraviroc
3. Currently receiving medication where the interaction would result in a dangerously high level of the concomitant drug
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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Composite end point of completion of 28 days of allocated PEP regimen without Grade 3 or 4 clinical or laboratory adverse events<br>2. Division of AIDS table for Grading the severity of Adult and Paediatric Adverse Events