PrEP, Lube, and the Rectal Mucosa in MSM at Risk of HIV
Condition: HIV
Intervention: Truvada; Gel lubricant
Intervention description: Truvada is a combination of 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate taken orally.; Five ml of an over the counter sexual lubricant will be dispensed using an applicator.
Intervention MeSH terms: Tenofovir; Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 86.0
Sex: Male
Minimum age: 18 Years
Maximum age: 49 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Human Immunodeficiency Virus; Acquired Immune Deficiency Syndrome Virus; Pre-exposure Prophylaxis

Summary:

      The purpose of this study is to determine whether the use of rectal lubricants can affect how
      well the medication, Truvada, will work to prevent infection with HIV when someone is exposed
      to HIV in the rectum.
    

Eligibility criteria:

        Inclusion Criteria:

          -  HIV-negative man who reports receptive anal sex with another man in the last 6 months
             aged 18-49 years

          -  Male to female transgender women who are not currently taking hormonal therapy or plan
             to take hormonal therapy for the duration of the study

          -  Not currently taking pre-exposure prophylaxis (PrEP) and no plans to initiate during
             study

          -  Able to provide informed consent in English

          -  No plans for relocation in the next 6 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 study visit 2 (4-16
             weeks after the screening visit)and 10 days prior to study visit 4 (5-26 weeks after
             the screening visit)

          -  Willing to abstain from receptive anal intercourse for 1 week after study visit 2
             (4-16 weeks after the screening visit) and study visit 4 (5-26 weeks after the
             screening visit)

        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 for rectal biopsies, including
             but not limited to:

               1. Hemoglobin (Hbg) ≤ 10 g/dL

               2. Partial thromboplastin time (PTT) > 1.5x upper limit normal (ULN) or
                  international normalized ratio (INR) > 1.5x ULN

               3. Platelet count <100,000

          -  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 nonsteroidal anti-inflammatory drugs (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 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