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: 0
• Participant gender: Male

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
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Projeto Praça Onze
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Raltegravir Potassium

Criteria

Inclusion Criteria:

Individuals will be included in the clinical trial if they meet ALL of the following criteria:

• Male sex (at birth);

• Willing and able to provide written informed consent;

• Age 18 years or older;

• HIV-1-uninfected;

• Absence of signs or symptoms compatible with an acute viral disease

• Evidence of high risk for acquiring HIV-1 infection including any one of the following: 1) No condom use during the last receptive and/or insertive anal intercourse with a male HIV-positive partner or a male partner of unknown HIV status during the last 6 months; (2) anal intercourse with more than 4 male sex partners during the last 6 months; (3) exchange of money, gifts, shelter, or drugs for anal sex with a male partner during the last 6 months; (4) sex with a male partner and STI diagnosis during the last 6 months or at screening, or (5) sexual partner of an HIV-infected man with whom condoms are not consistently used.

• Adequate renal function

• Adequate hepatic function

Exclusion Criteria:

• Glycosuria or proteinuria

• Acute hepatitis B infection

• History of pathological bone fractures not related to trauma

• Active alcohol or drug use considered sufficient to hinder compliance with any study procedures

• At enrollment, has any other condition that, based on the opinion of the investigator or designee, would preclude provision of informed consent; make participation in the study unsafe; complicate interpretation of study outcome data; or otherwise interfere with achieving the study objectives