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

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Autores
Categoría Estudio primario
Registro de estudiosISRCTN registry
Año 2012
INTERVENTION: 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 to Kaletra® (lopinavir 200 mg, ritonavir 50 mg), two tablets twice daily. These drugs are the standard combination currently in use in most centres for PEP in the UK. Experimental arm: Patients randomised to the experimental arm will receive 28 days treatment with Truvada® (tenofovir disoproxil ‐as fumarate‐ 245 mg, emtricitabine 200 mg), one tablet once daily in addition to maraviroc (300 mg), one tablet twice daily. CONDITION: HIV ; Infections and Infestations ; HIV PRIMARY OUTCOME: 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 OUTCOME: 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] 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
Epistemonikos ID: b3b530c8cf6ef9f2aa3b7584b1ea0887f42a9a1f
First added on: Aug 22, 2024