Biomarkers for Event-driven PrEP Adherence
Condition: Human Immunodeficiency Virus
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      This study aims to recruit 20 participants who will take the combination anti-HIV drug
      tenofovir+emtricitabine (TDF/FTC) at specified times. Participants will then provide biologic
      samples for the measurement of anti-retroviral drug concentrations in various body
      compartment sites. Participants will be involved in the study for up to 24 weeks.
    

Detailed description: 
      Men who have sex with men (MSM) continue to be disproportionately affected by HIV. In 2014,
      MSM made up approximately 2% of the U.S. population but accounted for 70% of the new HIV
      infections. The majority of MSM acquire HIV after exposure to the rectal mucosa through
      receptive anal intercourse without condoms. Pre-exposure prophylaxis (PrEP) and post-exposure
      prophylaxis (PEP) are recommended for MSM who may be exposed to HIV to prevent infection.
      Current recommendations for PrEP are to take the combination anti-HIV drug,
      tenofovir+emtricitabine (TDF/FTC), on a daily basis for the duration of someone's HIV risk
      exposure period, which could be months or years. For PEP, a three-drug anti-HIV medication is
      recommended within 72 hours of a possible exposure for a 28-day course. While PrEP and PEP
      are effective, some people find it difficult to follow the recommended regimen. Therefore,
      additional short-course dosing regimens for PrEP and PEP are being implemented, such as
      event-driven or on-demand PrEP (ED-PrEP). This dosing regimen has patients take two doses of
      PrEP 2-24 hours before sex, one dose 24 hours after sex, and another dose 48 hours after sex.
      This proposal seeks to evaluate the usefulness of biomarkers to confirm self-reported
      adherence to ED-PrEP in MSM. The study drug provided in this study will not protect
      participants from HIV or treat any active infection.

      This study will recruit 40 HIV-negative MSM aged 18-59 in good general health. Participants
      will be sequentially assigned to one of 2 study arms which will determine when they will take
      doses of the study drug and give specimen samples. All participants will provide written
      informed consent at the first study visit and undergo a screening medical history, physical
      exam, and safety laboratory tests. All participants will take at least 4 doses (pills) of the
      study drug. At study visits, participants will return to donate blood, hair, and urine
      samples, and a finger stick. All biologic specimens collected will be transferred to the
      Centers for Disease Control and Prevention (CDC) on the day of collection for measurement of
      drug levels.
    

Intervention name(s): TDF/FTC Dose Schedule for Arm A; TDF/FTC Dose Schedule for Arm B
Intervention type(s): Drug; Drug
Intervention description(s): TDF/FTC is a combination anti-HIV medication that contains the drugs tenofovir disoproxil fumarate (300 mg) and emtricitabine (200 mg). Participants will take 2 pills on Study Day 1, then one pill per day on Study Days 2 and 3. Participants will have biologic specimens collected at specific time points until 28 days after the last dose.; TDF/FTC is a combination anti-HIV medication that contains the drugs tenofovir disoproxil fumarate (300 mg) and emtricitabine (200 mg). Participants will be on a weekly dosing schedule of 2 pills on the first day, followed by one pill per day for the next two days. They will follow this dosing schedule for four weeks. Participants will have biologic specimens collected at specific time points until 28 days after the last dose.
Other intervention name(s): Truvada; Truvada
Intervention MeSH terms: Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Pre-exposure prophylaxis (PrEP); Post-exposure prophylaxis (PEP)