5305: Next PrEP Study
5305 FACT SHEET ( Next-PrEP Study )
A Phase II Randomized, Double-Blind, Study of the Safety and Tolerability of Maraviroc (MVC), Maraviroc + Emtricitabine (MVC+FTC), Maraviroc + Tenofovir disoproxil fumarate (MVC+TDF), or Tenofovir disoproxil fumarate + Emtricitabine (TDF+FTC) For Pre-Exposure Prophylaxis (PrEP) To Prevent HIV Transmission in At-Risk Men Who Have Sex with Men and in At Risk Women (ACTG 5305)
Purpose of This Trial:
To assess the safety and tolerability of four antiretroviral (ARV) drug regimens used as pre-exposure prophylaxis (PrEP) to prevent HIV transmission in HIV- negative men or women who have sex with men who are HIV positive or unknown of HIV status
You may be eligible if you are:
  • Born male or female, age 18y/o or greater
  • History of receptive or insertive anal intercourse or vaginal intercourse without use of condoms with at least one HIV-infected male partner or male partner of unknown HIV serostatus within three (3) months of study entry (provided by self-report)
  • Co-enrollment in any other HIV interventional research study (provided by self-report or other available documentation) or prior enrollment and receipt of active arm (i.e., NOT a placebo) of a HIV vaccine trial (provided by available documentation) is prohibited.
  • For women- not pregnant, planning pregnancy or currently breast feeding Use of ARV therapy (e.g., for PEP or PrEP) in the 90 days prior to study entry
  • Willing to undergo all required study procedures (including sexual assessment by computer assisted self-interview, use of the drug monitoring device, and SMS [i.e., texting])


Medications While On Study:
Maraviroc, Emtricitabine, Tenofovir, and placebo provided
Length of Study:
About 49 weeks
Schedule of Study Appointments:
Screening, Entry, and weeks 2, 4, 8, 16, 24, 32, 40, 48 and 49.
Clinical exams, study medications, and lab tests are provided at no cost. You will receive $20 per visit starting at Entry.
The ACTU Screening Nurse at 206-744-3184.