A Pilot Study on Raltegravir, Tenofovir and Emtricitabine for Peri-exposure Prophylaxis for HIV Infection
Status:
Unknown status
Trial end date:
2014-03-01
Target enrollment:
Participant gender:
Summary
This will be a pilot, open label study involving 65 participants. All participants will be
followed until seroconversion or until the last enrolled participant completes one year of
follow-up, whichever happens first. Participant study number will be given at the screening
visit, prior to inclusion in the study.
The chosen intervention and study regimen are based on the dynamics of viral infection and
the pharmacokinetics of the study drugs. In order to inhibit reverse transcription nucleoside
and nucleotide analogues need to be phosphorylated intracellularly. On the other hand,
available data indicate that it takes approximately 10 hours between exposure and HIV viral
integration, offering a window of opportunity for Raltegravir to block integration and thus
prevent infection, given that this drug does not need to be metabolized to exert its effect.
The intervention will be maintained for 4 weeks following exposure, in accordance with
Brazilian and CDC guidelines for PEP.
Phase:
Phase 3
Details
Lead Sponsor:
Projeto Praça Onze
Collaborator:
Merck Sharp & Dohme Corp.
Treatments:
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination Raltegravir Potassium