HIVPhase 4NCT02401230
PrEP, Lube, and the Rectal Mucosa in MSM at Risk of HIV
A Phase 4 study testing Truvada and Gel lubricant in people with HIV, run by Emory University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 49 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- Truvada and Gel lubricant
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to 25 Jan 2017
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 9Show fewer
- 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)
Who cannot join
- 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:
Show all 23Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The Hope Clinic of of Emory University
Decatur, Georgia, 30030
About this study
Official title: Defining the Rectal Mucosa in Men Who Have Sex With Men at Risk of HIV Infection
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.
Read the 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
- Being tested
- Truvada, Gel lubricant
- Keywords
- Human Immunodeficiency Virus, Acquired Immune Deficiency Syndrome Virus, Pre-exposure Prophylaxis
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TruvadaDrug
Also called Emtricitabine, Tenofovir
Truvada is a combination of 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate taken orally.
Gel lubricantDevice
Five ml of an over the counter sexual lubricant will be dispensed using an applicator.
| Study group | Role | What they receive |
|---|---|---|
| Rectal Gel Lubricant | Active comparator | Subjects will insert 5 mL of lubricant in rectum for seven consecutive days Receives: Device: Gel lubricant |
| Truvada | Active comparator | Subjects will take one Truvada tablet orally for seven consecutive days Receives: 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 Receives: Drug: Truvada; Device: Gel lubricant |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, Post-Intervention (Day 8)
Secondary outcomes (11)
Median Plasma Emtricitabine (FTC) Concentration
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.
Measured: Post-Intervention (Day 8)
Median Plasma Tenofovir (TDF) Concentration
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.
Measured: Post-Intervention (Day 8)
Median Rectal Secretion Emtricitabine (FTC) Concentration
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.
Measured: Post-Intervention (Day 8)
Median Rectal Secretion Tenofovir (TDF) Concentration
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.
Measured: Post-Intervention (Day 8)
Median Peripheral Blood Mononuclear Cell (PBMC) Emtricitabine (FTC) Concentration
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.
Measured: Post-Intervention (Day 8)
Median Peripheral Blood Mononuclear Cell (PBMC) Tenofovir (TDF) Concentration
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.
Measured: Post-Intervention (Day 8)
Median Rectal Tissue Emtricitabine (FTC) Concentration
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.
Measured: Post-Intervention (Day 8)
Median Rectal Tissue Tenofovir (TDF) Concentration
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.
Measured: Post-Intervention (Day 8)
Median Rectal Tissue Deoxyadenosine Triphosphate (dATP) Concentration
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.
Measured: Baseline, Post-Intervention (Day 8)
Median Rectal Tissue Deoxycytidine Triphosphate (dCTP) Concentration
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.
Measured: Baseline, Post-Intervention (Day 8)
Median Peripheral Blood Mononuclear Cell (PBMC) Deoxyadenosine Triphosphate (dATP) Concentration
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.
Measured: Baseline, Post-Intervention (Day 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2015 (estimated)
- Study startMar 2015
- Primary completion25 Jan 2017
- Study completion25 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Principal investigator, Colleen Kelley, Emory University
- Investigators
- Colleen Kelley, MD/MPH, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02401230
- Sponsor's protocol ID
- IRB00077593
- Status last verified
- Dec 2017
- First submitted
- 24 Mar 2015
- Last updated
- 19 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Defining the Rectal Mucosa in Men Who Have Sex With Men at Risk of HIV Infection
- ClinicalTrials.gov ID
- NCT02401230
- Acronym / sponsor ID
- IRB00077593
- Conditions
- HIV
- Keywords
- Human Immunodeficiency Virus, Acquired Immune Deficiency Syndrome Virus, Pre-exposure Prophylaxis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- Mar 2015 (actual)
- Primary completion
- 25 Jan 2017 (actual)
- Study completion
- 25 Jan 2017 (actual)
- First posted
- 27 Mar 2015 (estimated)
- Results
- Posted 19 Feb 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Rectal Gel Lubricant | Active comparator | Device: Gel lubricantSubjects will insert 5 mL of lubricant in rectum for seven consecutive days |
| Truvada | Active comparator | Drug: TruvadaSubjects will take one Truvada tablet orally for seven consecutive days |
| Rectal Gel Lubricant + Truvada | Active comparator | Drug: Truvada, Device: Gel lubricantSubjects will insert 5 mL of lubricant in rectum and take one Truvada tablet orally for seven consecutive days |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (23 listed)
- 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:
- 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:
- Continued need for, or use during the 14 days prior to enrollment, of the following medications:
- Continued need for, or use during the 90 days prior to enrollment, of the following medications:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TruvadaAlso: Emtricitabine, TenofovirTruvada is a combination of 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate taken orally. | Drug | Rectal Gel Lubricant + Truvada, Truvada |
| Gel lubricantFive ml of an over the counter sexual lubricant will be dispensed using an applicator. | Device | Rectal Gel Lubricant, Rectal Gel Lubricant + Truvada |
Primary outcome
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.
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.
11 secondary outcomes
Median Plasma Emtricitabine (FTC) Concentration
Time frame: Post-Intervention (Day 8)
Median Plasma Tenofovir (TDF) Concentration
Time frame: Post-Intervention (Day 8)
Median Rectal Secretion Emtricitabine (FTC) Concentration
Time frame: Post-Intervention (Day 8)
Median Rectal Secretion Tenofovir (TDF) Concentration
Time frame: Post-Intervention (Day 8)
Median Peripheral Blood Mononuclear Cell (PBMC) Emtricitabine (FTC) Concentration
Time frame: Post-Intervention (Day 8)
Median Peripheral Blood Mononuclear Cell (PBMC) Tenofovir (TDF) Concentration
Time frame: Post-Intervention (Day 8)
Median Rectal Tissue Emtricitabine (FTC) Concentration
Time frame: Post-Intervention (Day 8)
Median Rectal Tissue Tenofovir (TDF) Concentration
Time frame: Post-Intervention (Day 8)
Median Rectal Tissue Deoxyadenosine Triphosphate (dATP) Concentration
Time frame: Baseline, Post-Intervention (Day 8)
Median Rectal Tissue Deoxycytidine Triphosphate (dCTP) Concentration
Time frame: Baseline, Post-Intervention (Day 8)
Median Peripheral Blood Mononuclear Cell (PBMC) Deoxyadenosine Triphosphate (dATP) Concentration
Time frame: Baseline, Post-Intervention (Day 8)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
Related trials for HIV
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Colleen Kelley, MD/MPH principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Truvada and Gel lubricant in people with HIV, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Feb 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median Percentage of CD4 Positive T-Cells (time frame: Baseline, Post-Intervention (Day 8)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2018.