Intervention: Racivir
Trial phase: Phase 4
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: Accepts Healthy Volunteers
Participants at risk: 19
Group description: Subjects took one Truvada tablet orally for seven consecutive days.

Truvada: Truvada is a combination of 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate taken orally.
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:

Hemoglobin (Hbg) ≤ 10 g/dL
Partial thromboplastin time (PTT) > 1.5x upper limit normal (ULN) or international normalized ratio (INR) > 1.5x ULN
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:

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 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:

Aspirin or more than 4 doses of nonsteroidal anti-inflammatory drugs (NSAIDs)
Warfarin, heparin (low-molecular weight or unfractionated), platelet aggregation inhibitors, or fibrinolytic agents
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:

Systemic immunomodulatory agents
Supraphysiologic doses of steroids
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