Antiretroviral Therapy (ART) Persistence in Different Body Compartments in HIV Negative MSM
Condition: ART; HIV
Study type: Interventional
Phase: Phase 4

Summary: 
      The study seeks to understand how anti-HIV drug Biktarvy, which contains the drugs tenofovir
      alafenamide (TAF), emtricitabine (FTC), and bictegravir (BIC) is absorbed and how long it
      persists in different body compartments, including mucosal tissues, as it may be considered
      for PrEP or PEP regimens in the future.
    

Detailed description: 
      Men who have sex with men (MSM) continue to be disproportionately affected by HIV. 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 considered for future development.
      The study drug provided in this study will not protect participants from HIV or treat any
      active infection. This proposal seeks to understand how other anti-HIV medications are
      absorbed and how long they persist in different body compartments, including mucosal tissues,
      as they may be considered for PrEP or PEP regimens in the future.

      Participants will be sequentially enrolled into study arms. All participants will take two
      doses of Biktarvy and then will have biological samples collected at different time points.
      Blood will be collected at three different time points and a rectal biopsy will occur once.
      Participants may participate in more than one study arm or subgroup; however, at least 6
      weeks must lapse after completion of one study arm or subgroup, before entry into another.

      Median drug levels of TAF, FTC, and BIC in plasma, peripheral blood mononuclear cells (PBMCs)
      and rectal tissues will be calculated at baseline, 24 hours after the first dose and 120
      hours after the first dose as the primary outcomes of this study. Samples collected at other
      time points will be stored for future exploratory analyses.
    

Intervention name(s): Biktarvy
Intervention type(s): Drug
Intervention description(s): Participants will be given two doses of the oral fixed dose combination anti-HIV medication Biktarvy (BIC/FTC/TAF) separated by 24 hours. The first dose is given in the clinic and participants are instructed to take the second dose at home, 24 hours after the first dose.
Other intervention name(s): BIC/FTC/TAF
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: PrEP; PEP; MSM; Short-course regimen; Pharmacokinetics