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

NCT ID: NCT02401230

Last Updated: 2018-02-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2017-01-25

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.

Conditions

HIV

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Rectal Gel Lubricant

Subjects will insert 5 mL of lubricant in rectum for seven consecutive days

Group Type: ACTIVE_COMPARATOR

Gel lubricant

Intervention Type: DEVICE

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

Truvada

Subjects will take one Truvada tablet orally for seven consecutive days

Group Type: ACTIVE_COMPARATOR

Truvada

Intervention Type: DRUG

Truvada is a combination of 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate taken orally.

Rectal Gel Lubricant + Truvada

Subjects will insert 5 mL of lubricant in rectum and take one Truvada tablet orally for seven consecutive days

Group Type: ACTIVE_COMPARATOR

Truvada

Intervention Type: DRUG

Truvada is a combination of 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate taken orally.

Gel lubricant

Intervention Type: DEVICE

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

Interventions

Truvada

Truvada is a combination of 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate taken orally.

Intervention Type: DRUG

Gel lubricant

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

Intervention Type: DEVICE

Other Intervention Names

Emtricitabine; Tenofovir

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Centers for Disease Control and Prevention

FED

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Colleen Kelley

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Colleen Kelley, MD/MPH

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

The Hope Clinic of of Emory University

Decatur, Georgia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

IRB00077593

Identifier Type: -

Identifier Source: org_study_id