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PrEP, Lube, and the Rectal Mucosa in MSM at Risk of HIV

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02401230
Recruitment Status : Completed
First Posted : March 27, 2015
Results First Posted : February 19, 2018
Last Update Posted : February 19, 2018
Sponsor:
Collaborator:
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
Colleen Kelley, Emory University

Brief 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.

Condition or disease Intervention/treatment Phase
HIV Drug: Truvada Device: Gel lubricant Phase 4

Detailed Description:
Men who have sex with men (MSM) continue to be disproportionately affected by HIV. The majority of HIV infections among MSM occur through exposure to the rectal mucosa during receptive anal intercourse (RAI). During RAI, many MSM will use lubricants, which can potentially cause mucosal inflammation and damage. A new HIV prevention intervention, called pre-exposure prophylaxis (PrEP), recommends that MSM at risk of HIV infection take a daily anti-HIV medication called Truvada (tenofovir/emtricitabine) which is highly effective. However, it is not known if the use of lubricant during RAI will interfere with the efficacy of PrEP for HIV prevention.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Defining the Rectal Mucosa in Men Who Have Sex With Men at Risk of HIV Infection
Actual Study Start Date : March 2015
Actual Primary Completion Date : January 25, 2017
Actual Study Completion Date : January 25, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Active Comparator: Rectal Gel Lubricant
Subjects will insert 5 mL of lubricant in rectum for seven consecutive days
Device: Gel lubricant
Five ml of an over the counter sexual lubricant will be dispensed using an applicator.

Active Comparator: Truvada
Subjects will take one Truvada tablet orally for seven consecutive days
Drug: Truvada
Truvada is a combination of 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate taken orally.
Other Names:
  • Emtricitabine
  • Tenofovir

Active Comparator: Rectal Gel Lubricant + Truvada
Subjects will insert 5 mL of lubricant in rectum and take one Truvada tablet orally for seven consecutive days
Drug: Truvada
Truvada is a combination of 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate taken orally.
Other Names:
  • Emtricitabine
  • Tenofovir

Device: Gel lubricant
Five ml of an over the counter sexual lubricant will be dispensed using an applicator.




Primary Outcome Measures :
  1. Median Percentage of CD4 Positive T-Cells [ Time Frame: Baseline, Post-Intervention (Day 8) ]
    HIV target cell availability will be assessed by the median percentage of CD4+ T cells that express HIV co-receptor CCR5 as measured prior to product use and on day 8 after product use.

  2. Median Cumulative Amount of p24 [ Time Frame: Baseline, Post-Intervention (Day 8) ]
    The median cumulative amount of p24 produced in a rectal explant challenge assay as measured by ELISA from participants prior to product use and on day 8 after product use.


Secondary Outcome Measures :
  1. Median Plasma Emtricitabine (FTC) Concentration [ Time Frame: Post-Intervention (Day 8) ]
    Median plasma FTC concentration as measured in ng/ml prior to product use and on day 8 after product use. The higher the concentration, the better the drug distribution.

  2. Median Plasma Tenofovir (TDF) Concentration [ Time Frame: Post-Intervention (Day 8) ]
    Median plasma TDF concentration as measured in ng/ml prior to product use and on day 8 after product use. The higher the concentration, the better the drug distribution.

  3. Median Rectal Secretion Emtricitabine (FTC) Concentration [ Time Frame: Post-Intervention (Day 8) ]
    Median rectal secretions FTC concentrations as measured in ng/swab prior to product use and on day 8 after product use. The higher the concentration, the better the drug distribution.

  4. Median Rectal Secretion Tenofovir (TDF) Concentration [ Time Frame: Post-Intervention (Day 8) ]
    Median rectal secretions TDF concentrations as measured in ng/swab prior to product use and on day 8 after product use. The higher the concentration, the better the drug distribution.

  5. Median Peripheral Blood Mononuclear Cell (PBMC) Emtricitabine (FTC) Concentration [ Time Frame: Post-Intervention (Day 8) ]
    Median blood PBMC FTC concentrations as measured in fmol/million cells prior to product use and on day 8 after product use. The higher the concentration, the better the drug distribution.

  6. Median Peripheral Blood Mononuclear Cell (PBMC) Tenofovir (TDF) Concentration [ Time Frame: Post-Intervention (Day 8) ]
    Median blood PBMC TDF concentrations as measured in fmol/million cells prior to product use and on day 8 after product use. The higher the concentration, the better the drug distribution.

  7. Median Rectal Tissue Emtricitabine (FTC) Concentration [ Time Frame: Post-Intervention (Day 8) ]
    Median rectal tissue FTC concentrations as measured in fmol/mg tissue prior to product use and on day 8 after product use. The higher the concentration, the better the drug distribution.

  8. Median Rectal Tissue Tenofovir (TDF) Concentration [ Time Frame: Post-Intervention (Day 8) ]
    Median rectal tissue TDF concentrations as measured in fmol/mg tissue prior to product use and on day 8 after product use. The higher the concentration, the better the drug distribution.

  9. Median Rectal Tissue Deoxyadenosine Triphosphate (dATP) Concentration [ Time Frame: Baseline, Post-Intervention (Day 8) ]
    Median rectal tissue dATP concentrations as measured in fmol/mg tissue prior to product use and on day 8 after product use. The higher the concentration, the better the drug distribution.

  10. Median Rectal Tissue Deoxycytidine Triphosphate (dCTP) Concentration [ Time Frame: Baseline, Post-Intervention (Day 8) ]
    Median rectal tissue dCTP concentrations as measured in fmol/mg tissue prior to product use and on day 8 after product use. The higher the concentration, the better the drug distribution.

  11. Median Peripheral Blood Mononuclear Cell (PBMC) Deoxyadenosine Triphosphate (dATP) Concentration [ Time Frame: Baseline, Post-Intervention (Day 8) ]
    Median blood dATP concentrations as measured in fmol/million cells prior to product use and on day 8 after product use. The higher the concentration, the better the drug distribution.



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
Accepts Healthy Volunteers:   Yes
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

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): NCT02401230


Locations
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United States, Georgia
The Hope Clinic of of Emory University
Decatur, Georgia, United States, 30030
Sponsors and Collaborators
Emory University
Centers for Disease Control and Prevention
Investigators
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Principal Investigator: Colleen Kelley, MD/MPH Emory University
  Study Documents (Full-Text)

Documents provided by Colleen Kelley, Emory University:
Study Protocol  [PDF] September 26, 2016
Statistical Analysis Plan  [PDF] January 19, 2018

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Responsible Party: Colleen Kelley, Assistant Professor, Emory University
ClinicalTrials.gov Identifier: NCT02401230    
Other Study ID Numbers: IRB00077593
First Posted: March 27, 2015    Key Record Dates
Results First Posted: February 19, 2018
Last Update Posted: February 19, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Colleen Kelley, Emory University:
Human Immunodeficiency Virus
Acquired Immune Deficiency Syndrome Virus
Pre-exposure Prophylaxis
Additional relevant MeSH terms:
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Tenofovir
Emtricitabine
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents