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ART Persistence in Different Body Compartments in HIV Negative MSM

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ClinicalTrials.gov Identifier: NCT04039217
Recruitment Status : Recruiting
First Posted : July 31, 2019
Last Update Posted : November 19, 2019
Sponsor:
Information provided by (Responsible Party):
Colleen Kelley, Emory University

Brief Summary:
The study seeks to understand how anti-HIV drug Biktarvy - tenofovir+emtricitabine+bictegrativir (TAF/FTC/BIC) is absorbed and how long it persists in different body compartments, including mucosal tissues, as it may be considered for PrEP or PEP regimens in the future.

Condition or disease Intervention/treatment Phase
ART HIV Drug: Biktarvy Phase 4

Detailed Description:
Men who have sex with men (MSM) continue to be disproportionately affected by HIV. The majority of MSM acquire HIV after exposure to the rectal mucosa through receptive anal intercourse without condoms. Pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP) are recommended for MSM who may be exposed to HIV to prevent infection. Current recommendations for PrEP are to take the combination anti-HIV drug, tenofovir+emtricibatine (TDF/FTC), on a daily basis for the duration of someone's HIV risk exposure period, which could be months or years. For PEP, a three-drug anti-HIV medication is recommended within 72 hours of a possible exposure for a 28-day course. While PrEP and PEP are effective, some people find it difficult to follow the recommended regimen. Therefore, additional short-course dosing regimens for PrEP and PEP are being considered for future development. The study drug provided in this study will not protect participants from HIV or treat any active infection. This proposal seeks to understand how other anti-HIV medications are absorbed and how long they persist in different body compartments, including mucosal tissues, as they may be considered for PrEP or PEP regimens in the future.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: ART Persistence: Antiretroviral Drug Persistence in Different Body Compartments in HIV Negative Men Who Have Sex With Men
Actual Study Start Date : September 30, 2019
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Group A
Group A will provide biological specimens 2, 48, and 96 hours after the in-clinic dose of TAF/FTC/BIC. Approximately 24 mL of blood will be drawn, an oral cheek swab, 1 pre- wet penile swab and 1 dry penile swab, and a urethral swab will be collected. After previous swab collections are complete, participants will be asked to provide a urine sample (some of which will be used for gonorrhea and chlamydia testing). Participants will undergo rectal biopsy collection at 1 study timepoint.
Drug: Biktarvy
Participants will be given 2 doses of the oral fixed dose combination anti-HIV medication Biktarvy (TAF/FTC/BIC) separated by 24 hours
Other Name: TAF/FTC/BIC

Experimental: Group B
Group B will provide biological specimens 4, 26, and 120 hours after the in-clinic dose of TAF/FTC/BIC. Approximately 24 mL of blood will be drawn, an oral cheek swab, 1 pre- wet penile swab and 1 dry penile swab, and a urethral swab will be collected. After previous swab collections are complete, participants will be asked to provide a urine sample (some of which will be used for gonorrhea and chlamydia testing). Participants will undergo rectal biopsy collection at 1 study timepoint.
Drug: Biktarvy
Participants will be given 2 doses of the oral fixed dose combination anti-HIV medication Biktarvy (TAF/FTC/BIC) separated by 24 hours
Other Name: TAF/FTC/BIC

Experimental: Group C
Group C will provide biological specimens 24, 28, and 72 hours after the in-clinic dose of TAF/FTC/BIC. Approximately 24 mL of blood will be drawn, an oral cheek swab, 1 pre- wet penile swab and 1 dry penile swab, and a urethral swab will be collected. After previous swab collections are complete, participants will be asked to provide a urine sample (some of which will be used for gonorrhea and chlamydia testing). Participants will undergo rectal biopsy collection at 1 study timepoint.
Drug: Biktarvy
Participants will be given 2 doses of the oral fixed dose combination anti-HIV medication Biktarvy (TAF/FTC/BIC) separated by 24 hours
Other Name: TAF/FTC/BIC




Primary Outcome Measures :
  1. Change in Peripheral blood mononuclear cells (PBMCs) median drug (TAF/FTC/BIC) levels [ Time Frame: Baseline, twenty four hours after the first dose, and 120 hours after first dose ]
    Median (range) drug levels (TAF/FTC/BIC) will be calculated. Differences in median drug levels between baseline and study follow-up visits will be analyzed with non-parametric Wilcoxon-signed rank tests. A p-value of <0.05 will be considered significant.

  2. Change in plasma median drug (TAF/FTC/BIC) levels [ Time Frame: Baseline, twenty four hours after the first dose, and 120 hours after first dose ]
    Median (range) drug levels (TAF/FTC/BIC) will be calculated. Differences in median drug levels between baseline and study follow-up visits will be analyzed with non-parametric Wilcoxon-signed rank tests. A p-value of <0.05 will be considered significant.

  3. Change in rectal tissues median drug (TAF/FTC/BIC) levels [ Time Frame: Baseline, twenty four hours after the first dose, and 120 hours after first dose ]
    Median (range) drug levels (TAF/FTC/BIC) will be calculated. Differences in median drug levels between baseline and study follow-up visits will be analyzed with non-parametric Wilcoxon-signed rank tests. A p-value of <0.05 will be considered significant.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Men
Accepts Healthy Volunteers:   No
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.
  10. Hepatitis B surface antigen (HBsAg) must be negative (screening lab test)
  11. Creatine clearance >60 ml/min

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. Currently infected with hepatitis virus and/ or have liver disease
  3. Current or chronic history of kidney disease
  4. 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
    5. HBsAg reactive
  5. 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, 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
  6. 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
  7. 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 (short course steroids less than 7 days duration, allowable at the discretion of the investigators)
    3. Experimental medications, vaccines, or biologicals
  8. Intent to use HIV antiretroviral pre/post-exposure prophylaxis (PrEP or PEP) during the study, outside of the study procedures
  9. Symptoms of an untreated rectal sexually transmitted infection (e.g. rectal pain, discharge, bleeding, etc.)
  10. Current use of hormonal therapy
  11. 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.
  12. Participants taking potent inhibitors (e.g. itraconazole, diltiazem) or inducers (e.g. rifampin, phenytoin) of the CYP3A4 enzyme will be excluded from the study.

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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04039217


Contacts
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Contact: Colleen Kelley, MD 404-712-1823 colleen.kelley@emory.edu

Locations
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United States, Georgia
Hope Clinic Recruiting
Atlanta, Georgia, United States, 30322
Contact: Colleen Kelley, MD    404-712-1823    colleen.kelley@emory.edu   
Sponsors and Collaborators
Emory University
Investigators
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Principal Investigator: Colleen Kelley, MD Emory University
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Responsible Party: Colleen Kelley, Principal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT04039217    
Other Study ID Numbers: IRB00111410
First Posted: July 31, 2019    Key Record Dates
Last Update Posted: November 19, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data that underlie the results reported in this article, after de-identification (e.g., text, tables, figures, and appendices), will be available. The study protocol will be available.
Supporting Materials: Study Protocol
Time Frame: Data will become available Beginning 9 months and ending at 36 months following publication to researchers who provide a methodologically sound proposal.
Access Criteria: Proposals should be directed to colleen.kelley@emory.edu. To gain access, data requestors will need to sign a data access agreement.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Colleen Kelley, Emory University:
PrEP
PEP
MSM
Short-course regimen
Pharmacokinetics