Overview

Body Compartment Pharmacokinetics of Anti- Retroviral Agents That May be Used for Future HIV Post- Exposure Prophylaxis.

Status:
Completed
Trial end date:
2019-03-29
Target enrollment:
0
Participant gender:
Male
Summary
This study is being conducted to determine if the uptake of anti-HIV medications called Genvoya® and darunavir is different at several body sites, including mucosal tissues.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Emory University
Collaborator:
Centers for Disease Control and Prevention
Treatments:
Anti-Retroviral Agents
Darunavir
Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Criteria
Inclusion Criteria:

1. HIV-negative man who reports receptive anal sex with another man in the last 6 months

2. Aged 18-49 years

3. Not currently taking PrEP and no plans to initiate during study

4. Not currently taking PEP

5. Able to provide informed consent in English

6. No plans for relocation in the next 3 months

7. Willing to undergo peripheral blood, penile swabs, urine, and rectal biopsy sampling

8. Willing to use study products as directed

9. 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:

1. 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

2. 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

3. 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 mucosa, or untreated sexually transmitted
disease with mucosal involvement

4. 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 lubricants or douching used for
sexual intercourse

5. 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

6. Intent to use HIV antiretroviral pre/post-exposure prophylaxis (PrEP or PEP) during
the study, outside of the study procedures

7. Symptoms of an untreated rectal sexually transmitted infection (e.g. rectal pain,
discharge, bleeding, etc.)

8. Current use of hormonal therapy

9. 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.