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

NCT02401230 | Completed Phase 4 Results FDA Drug FDA Device

• 1 other identifier: IRB00077593
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV

Keywords

Human Immunodeficiency Virus; Acquired Immune Deficiency Syndrome Virus; Pre-exposure Prophylaxis

Outcome Measures

Primary Outcomes (2)

• Median Percentage of CD4 Positive T-Cells

  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)

• Median Cumulative Amount of p24

  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)

Secondary Outcomes (11)

• Median Plasma Emtricitabine (FTC) Concentration

  Post-Intervention (Day 8)

• Median Plasma Tenofovir (TDF) Concentration

  Post-Intervention (Day 8)

• Median Rectal Secretion Emtricitabine (FTC) Concentration

  Post-Intervention (Day 8)

• Median Rectal Secretion Tenofovir (TDF) Concentration

  Post-Intervention (Day 8)

• Median Peripheral Blood Mononuclear Cell (PBMC) Emtricitabine (FTC) Concentration

  Post-Intervention (Day 8)

Study Arms (3)

Rectal Gel Lubricant

ACTIVE COMPARATOR

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

Device: Gel lubricant

Truvada

ACTIVE COMPARATOR

Subjects will take one Truvada tablet orally for seven consecutive days

Drug: Truvada

Rectal Gel Lubricant + Truvada

ACTIVE COMPARATOR

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

Drug: Truvada; Device: Gel lubricant

Interventions

Truvada DRUG

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

Also known as: Emtricitabine, Tenofovir

Rectal Gel Lubricant + Truvada; Truvada

Gel lubricant DEVICE

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

Rectal Gel Lubricant; Rectal Gel Lubricant + Truvada

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead
• Centers for Disease Control and Prevention: collaborator

Study Sites (1)

The Hope Clinic of of Emory University

Decatur, Georgia, 30030, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Emtricitabine; Tenofovir

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Drug Combinations; Pharmaceutical Preparations

Results Point of Contact

• Title: Dr. Colleen Kelley
• Organization: Emory University

colleen.kelley@emory.edu

404-712-1823

Study Officials

• Colleen Kelley, MD/MPH

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 24, 2015
• First Posted: March 27, 2015
• Study Start: March 1, 2015
• Primary Completion: January 25, 2017
• Study Completion: January 25, 2017
• Last Updated: February 19, 2018
• Results First Posted: February 19, 2018

Record last verified: 2017-12

Locations

US (1)