Clinical trial NCT02401230: PrEP, Lube, and the Rectal Mucosa in MSM at Risk of HIV
Official title: Defining the Rectal Mucosa in Men Who Have Sex With Men at Risk of HIV Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV
Keywords: Human Immunodeficiency Virus
Acquired Immune Deficiency Syndrome Virus
Pre-exposure Prophylaxis
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2015-03-27
Enrollment: 86
Sex: MALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

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:

  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

Primary outcomes:
measure: Median Percentage of CD4 Positive T-Cells
timeFrame: Baseline, Post-Intervention (Day 8)
measure: Median Cumulative Amount of p24
timeFrame: Baseline, Post-Intervention (Day 8)
Secondary outcomes:
measure: Median Plasma Emtricitabine (FTC) Concentration
timeFrame: Post-Intervention (Day 8)
measure: Median Plasma Tenofovir (TDF) Concentration
timeFrame: Post-Intervention (Day 8)
measure: Median Rectal Secretion Emtricitabine (FTC) Concentration
timeFrame: Post-Intervention (Day 8)
measure: Median Rectal Secretion Tenofovir (TDF) Concentration
timeFrame: Post-Intervention (Day 8)
measure: Median Peripheral Blood Mononuclear Cell (PBMC) Emtricitabine (FTC) Concentration
timeFrame: Post-Intervention (Day 8)
measure: Median Peripheral Blood Mononuclear Cell (PBMC) Tenofovir (TDF) Concentration
timeFrame: Post-Intervention (Day 8)
measure: Median Rectal Tissue Emtricitabine (FTC) Concentration
timeFrame: Post-Intervention (Day 8)
measure: Median Rectal Tissue Tenofovir (TDF) Concentration
timeFrame: Post-Intervention (Day 8)
measure: Median Rectal Tissue Deoxyadenosine Triphosphate (dATP) Concentration
timeFrame: Baseline, Post-Intervention (Day 8)
measure: Median Rectal Tissue Deoxycytidine Triphosphate (dCTP) Concentration
timeFrame: Baseline, Post-Intervention (Day 8)
measure: Median Peripheral Blood Mononuclear Cell (PBMC) Deoxyadenosine Triphosphate (dATP) Concentration
timeFrame: Baseline, Post-Intervention (Day 8)
Other outcomes:
Locations:
city: Decatur
country: United States
facility: The Hope Clinic of of Emory University
state: Georgia
Study officials:
affiliation: Emory University
name: Colleen Kelley, MD/MPH
role: PRINCIPAL_INVESTIGATOR
References: