Prophylaxis and prevention of HIV Infection. MedDRA version: 14.1 Level: PT Classification code 10020161 Term: HIV infection System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Celsentri
Product Name: Maraviroc
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Maraviroc
CAS Number: 376348-
Sponsors
Camden Provider Services
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Patients taking current combinations of PEP frequently report side effects and completion rates of the full 28 day course of medication is often poor. This may compromise the protective effect of PEP. The availability of a better tolerated combination would be beneficial to patients. Principal study objective is to compare the tolerability and completion rate between standard PEP drug combination and maraviroc based-PEP. Composite end point of completion of 28 days of allocated PEP regimen without grade 3 or 4 clinical or laboratory adverse events related to the PEP medication. Investigators will determine whether clinical or laboratory adverse events are related to the PEP medication at the time of the event. All adverse events will be reviewed by an independent panel.;Secondary Objective: The objectives are to compare the following: Completion rates of the two PEP regimens Compare the numbers of patients experiencing side effects (clinical adverse events and blood/urine test abnormalities) between the two combinations Compare the numbers of patients who need to change or stop their PEP as well as the reasons why Compare the rates of missed tablets between the two groups We will collect information regarding the rate of people catching HIV or other sexually transmitted infections (gonorrhoea, Chlamydia, LGV, syphilis, hepatitis B and C) and any differences between the levels of sexual risk taking behaviour. This will focus upon the proportion of individuals reporting unprotected anal/vaginal intercourse in i) the three months preceding PEP, ii) while receiving PEP and iii) in the three months post completion of PEP with a potentially sero-discordant partner.;Primary end point(s): Composite end point of completion of 28 days of allocated PEP regimen without grade 3 or 4 clinical or laboratory adverse events.;Timepoint(s) of evaluation of this end point: This is a 4 month study to compare the tolerability and completion of maraviroc compared to Kalet | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Completion rates of 28 days of allocated PEP regimen • Rates of Grade 1, 2, 3 or 4 clinical adverse events • Rates of grade 1, 2, 3 or 4 laboratory abnormalities • Rates and causes of regimen modification or discontinuation • Number of missed doses of Truvada® over 28 day course of PEP • Number of missed doses of Kaletra® or maraviroc over 28 day course of PEP • Number of doses of antidiarrhoeal medication taken • Number of doses of antiemetic taken • Number of days absent from work or college (not including days attending for clinic visits) • Number of clinic visits required • Rates of HIV seroconversion at month 4 after exposure. • Sexual behaviour- proportion of individuals reporting unprotected anal/vaginal intercourse in i) the three months preceding PEP, ii) while receiving PEP and iii) in the three months post completion of PEP with a potentially sero-discordant partner • Number of sexual partners in i) the three month period preceding PEP, ii) while receiving PEP and iii) the three month period following PEP • Rates of sexually transmitted infections (gonorrhoea, Chlamydia, LGV, syphilis, hepatitis B and C);Timepoint(s) of evaluation of this end point: This is a 4 month study to compare the tolerability and completion of maraviroc compared to Kaletra© in combination with Truvada© for HIV post exposure prophylaxis. Recruitment to the trial will be conducted over 12 months. Patients will be randomised to receive coformulated tenofovir disoproxil fumarate/emtricitabine (Truvada©) with either maraviroc (experimental arm) or lopinavir/ritonavir (Kaletra©) (control arm) for 28 days. Participants will be asked to visit the clinic on 3 occasions (Days 14 and 28, and Month 4 visits). This is the same number of clinic visits as suggested by current guidelines for PEP. | — |
Countries
United Kingdom
Contacts
Public ContactAngela Williams
Camden Provider Services
Outcome results
None listed