HIV Infections and Infestations HIV
Conditions
Interventions
Control arm:
Patients randomised to the control arm will receive 28 days treatment with Truvada® (tenofovir disoproxil - as fumarate, 245 mg, emtricitabine 200 mg), one tablet once daily in addition t
Sponsors
Central and North West London NHS Foundation Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Composite end point of completion of 28 days of allocated PEP regimen without Grade 3 or 4 clinical or laboratory adverse events 2. Division of AIDS table for Grading the severity of Adult and Paediatric Adverse Events | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Completion rates of 28 days of allocated PEP regimen 2. Rates of Grade 1, 2, 3 or 4 clinical adverse events 3. Rates of Grade 1, 2, 3 or 4 laboratory anormalities 4. Rates and causes of regimen modification or discontinuation 5. Number of missed doses of Truvada® over 28 day course of PEP 6. Number of missed doses of Kaletra®or maraviroc over 28 day course of PEP 7. Number of doses of antidiarrhoeal medication taken 8. Number of doses of antiemetic taken 9. Number of days absent from work or college (not including days attending for clinic visits) 10. Number of clinic visits required 11. Rates of HIV seroconversion at month 4 after exposure 12. Proportion of individuals reporting unprotected anal/vaginal intercourse in 12.1. The three months preceeding PEP 12.2. While receiving PEP and 12.3. In the three months post completion of PEP with a potentially sero-discordant partner 13. Number of sexual partners in 13.1. The three month period preceeding PEP 13.2. While receiving PEP 13.3. The three month period following PEP 14. Rates of sexually transmitted infections [gonorrhoea, chlamydia, Lymphogranuloma venereum (LGV), syphilis, hepatitis B and C] | — |
Countries
United Kingdom
Outcome results
None listed