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| 5305 FACT SHEET ( Next-PrEP Study ) |
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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)
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Purpose of This Trial:
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| 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
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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])
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| Medications While On Study: |
| Maraviroc, Emtricitabine, Tenofovir, and placebo provided
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| Length of Study: |
| About 49 weeks
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Schedule of Study Appointments: |
Screening, Entry, and weeks 2, 4, 8, 16, 24, 32, 40, 48 and 49.
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| Reimbursement: |
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Clinical exams, study medications, and lab tests are provided at no cost.
You will receive $20 per visit starting at Entry.
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Contact: |
The ACTU Screening Nurse at 206-744-3184.
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