Body Compartment PK for New HIV Pre-exposure Prophylaxis Modalities
Condition: HIV Infections
MeSH terms: HIV Infections
Intervention: Truvada; Genvoya
Intervention description: Truvada is intended for the treatment of HIV-1 infection. Truvada is a combination of emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg in one tablet.; Genvoya is a 1-pill, once-a-day prescription medicine used to treat HIV-1. Genvoya is a combination of 150 mg of elvitegravir, 150 mg of cobicistat, 200 mg of emtricitabine, and 10 mg of tenofovir alafenamid in one tablet.
Intervention MeSH terms: Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 48.0
Sex: Male
Minimum age: 18 Years
Maximum age: 49 Years
Healthy volunteers: No
Keywords: Preventative Medicine; Infectious Diseases; Sexually Transmitted Diseases

Summary:

      The purpose of this study is to determine the ability of new anti-HIV agents to penetrate
      different body compartments in HIV negative men who have sex with men and transgender women.
      These new agents might be considered for pre-exposure prophylaxis regimens in the future.
      This study will include 90 healthy, HIV-negative men who have sex with men and transgender
      women who are not taking hormones aged 18-49 years. Participant must be willing to
      participate in 1 of the 3 study phases, be willing to take Truvada® (PrEP) or Genvoya®, and
      willing to undergo blood draws, urethral swabs, and rectal biopsy procedures.
    

Eligibility criteria:

        Inclusion Criteria:

          -  HIV-negative man who reports receptive anal sex with another man in the last 6 months

          -  Male to female transgender women who have sex with men who report receptive anal
             intercourse with another man in the last 6 months and are not currently taking
             hormonal therapy or plan to take hormonal therapy for the duration of the study

          -  Not currently taking PrEP and no plans to initiate during study

          -  Able to provide informed consent in English

          -  No plans for relocation in the next 3 months

          -  Willing to undergo peripheral blood and rectal biopsy sampling

          -  Willing to use study products as directed

          -  Willing to abstain from receptive anal intercourse 3 days prior to starting study
             product and for the duration of the study and for 7 days after any rectal biopsy
             procedure.

        Exclusion Criteria:

          -  History of inflammatory bowel disease or other inflammatory, infiltrative, infectious
             or vascular condition involving the lower gastrointestinal tract that, in the judgment
             of the investigators, may be worsened by study procedures or may significantly distort
             the anatomy of the distal large bowel

          -  Significant laboratory abnormalities at baseline visit, including but not limited to:

               1. Hgb ≤ 10 g/dL

               2. PTT > 1.5x ULN or INR > 1.5x ULN

               3. Platelet count <100,000

               4. Creatinine clearance <60

          -  Any known medical condition that, in the judgment of the investigators, increases the
             risk of local or systemic complications of endoscopic procedures or pelvic
             examination, including but not limited to:

               1. Uncontrolled or severe cardiac arrhythmia

               2. Recent major abdominal, cardiothoracic, or neurological surgery

               3. History of uncontrolled bleeding diathesis

               4. History of colonic, rectal, or vaginal perforation, fistula, or malignancy

               5. History or evidence on clinical examination of ulcerative, suppurative, or
                  proliferative lesions of the anorectal or vaginal mucosa, or untreated sexually
                  transmitted disease with mucosal involvement

          -  Continued need for, or use during the 14 days prior to enrollment, of the following
             medications:

               1. Aspirin or more than 4 doses of NSAIDs

               2. Warfarin, heparin (low-molecular weight or unfractionated), platelet aggregation
                  inhibitors, or fibrinolytic agents

               3. Any form of rectally administered agent besides products lubricants or douching
                  used for sexual intercourse

          -  Continued need for, or use during the 90 days prior to enrollment, of the following
             medications:

               1. Systemic immunomodulatory agents

               2. Supraphysiologic doses of steroids

               3. Experimental medications, vaccines, or biologicals

          -  Intent to use HIV antiretroviral pre-exposure prophylaxis (PrEP) during the study,
             outside of the study procedures

          -  Symptoms of an untreated rectal sexually transmitted infection (e.g. rectal pain,
             discharge, bleeding, etc.)

          -  Current use of hormonal therapy

          -  Any other clinical condition or prior therapy that, in the opinion of the
             investigator, would make the patient unsuitable for the study or unable to comply with
             the study requirements.