Intervention: Racivir
Trial phase: Phase 1
ATC code: J05AF09 | J05AR03 | J05AR06 | J05AR08 | J05AR09 | J05AR17 | J05AR18 | J05AR19 | J05AR20 | J05AR22
SMILES: Nc1nc(=O)n(C2CSC(CO)O2)cc1F
Sex: Male
Age groups: Adult
Healthy volunteers: No
Participants at risk: 41
Group description: Specimen collection 4 hours after taking the medication in the clinic (visit 4), and 72 hours after taking the medication in the clinic (visit 5).

Genvoya: Genvoya is a fixed-dose combination anti-retroviral drug containing tenofovir alafenamide (TAF), emtricitabine (FTC), elvitegravir (EVG), and cobicistat.

At the second study visit, participants will be provided with a single dose of Genvoya, and instructed to take the dose at home with documentation by digital, time-stamped photo or video. At the third study visit, which will occur 24 hours after home dosing, participants will be given another single dose of Genvoya at the clinic.
Eligibility criteria:
Inclusion Criteria:

HIV-negative man who reports receptive anal sex with another man in the last 6 months
Aged 18-49 years
Not currently taking PrEP and no plans to initiate during study
Not currently taking PEP
Able to provide informed consent in English
No plans for relocation in the next 3 months
Willing to undergo peripheral blood, penile swabs, urine, 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.
Hepatitis B surface antigen (HBsAg) must be negative (screening lab test)
Creatine clearance >60 ml/min

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
Currently infected with hepatitis virus and/ or have liver disease
Current or chronic history of kidney disease

Significant laboratory abnormalities at baseline visit, including but not limited to:

Hgb ≤ 10 g/dL
Partial thromboplastin time (PTT) > 1.5x upper limit of normal (ULN) or international normalized ratio (INR) > 1.5x ULN
Platelet count <100,000
Creatinine clearance <60
HBsAg reactive

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:

Uncontrolled or severe cardiac arrhythmia
Recent major abdominal, cardiothoracic, or neurological surgery
History of uncontrolled bleeding diathesis
History of colonic, rectal, or vaginal perforation, fistula, or malignancy
History or evidence on clinical examination of ulcerative, suppurative, or proliferative lesions of the anorectal 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:

Aspirin or more than 4 doses of NSAIDs
Warfarin, heparin (low-molecular weight or unfractionated), platelet aggregation inhibitors, or fibrinolytic agents
Any form of rectally administered agent besides lubricants or douching used for sexual intercourse

Continued need for, or use during the 90 days prior to enrollment, of the following medications:

Systemic immunomodulatory agents
Supraphysiologic doses of steroids (short course steroids less than 7 days duration, allowable at the discretion of the investigators)
Experimental medications, vaccines, or biologicals
Intent to use HIV antiretroviral pre/post-exposure prophylaxis (PrEP or PEP) 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.
Participants taking potent inhibitors (e.g. itraconazole, diltiazem) or inducers (e.g. rifampin, phenytoin) of the CYP3A4 enzyme that also metabolizes Genvoya will be excluded from the study