- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02401230
PrEP, Lube, and the Rectal Mucosa in MSM at Risk of HIV
Defining the Rectal Mucosa in Men Who Have Sex With Men at Risk of HIV Infection
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Georgia
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Decatur, Georgia, United States, 30030
- The Hope Clinic of of Emory University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Rectal Gel Lubricant
Subjects will insert 5 mL of lubricant in rectum for seven consecutive days
|
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
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Truvada is a combination of 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate taken orally.
Other Names:
|
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
|
Five ml of an over the counter sexual lubricant will be dispensed using an applicator.
Truvada is a combination of 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate taken orally.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline, Post-Intervention (Day 8)
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Median Cumulative Amount of p24
Time Frame: Baseline, Post-Intervention (Day 8)
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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.
|
Baseline, Post-Intervention (Day 8)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Median Plasma Emtricitabine (FTC) Concentration
Time Frame: Post-Intervention (Day 8)
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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.
|
Post-Intervention (Day 8)
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Median Plasma Tenofovir (TDF) Concentration
Time Frame: Post-Intervention (Day 8)
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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.
|
Post-Intervention (Day 8)
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Median Rectal Secretion Emtricitabine (FTC) Concentration
Time Frame: Post-Intervention (Day 8)
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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.
|
Post-Intervention (Day 8)
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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.
|
Post-Intervention (Day 8)
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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.
|
Post-Intervention (Day 8)
|
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.
|
Post-Intervention (Day 8)
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Median Rectal Tissue Emtricitabine (FTC) Concentration
Time Frame: Post-Intervention (Day 8)
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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.
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Post-Intervention (Day 8)
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Median Rectal Tissue Tenofovir (TDF) Concentration
Time Frame: Post-Intervention (Day 8)
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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.
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Post-Intervention (Day 8)
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Median Rectal Tissue Deoxyadenosine Triphosphate (dATP) Concentration
Time Frame: Baseline, Post-Intervention (Day 8)
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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.
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Baseline, Post-Intervention (Day 8)
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Median Rectal Tissue Deoxycytidine Triphosphate (dCTP) Concentration
Time Frame: Baseline, Post-Intervention (Day 8)
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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.
|
Baseline, Post-Intervention (Day 8)
|
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.
|
Baseline, Post-Intervention (Day 8)
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Colleen Kelley, MD/MPH, Emory University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00077593
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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