HIV InfectionsPhase 1PEP2NCT03472963
Body Compartment Pharmacokinetics of Anti- Retroviral Agents That May be Used for Future HIV Post- Exposure Prophylaxis.
A Phase 1 study testing Single dose of Genvoya® and a single 800 mg dose of Darunavir® in people with HIV Infections, run by Emory University at 1 site in United States.
Trial summary
This study is being conducted to determine if the uptake of anti-HIV medications called Genvoya® and darunavir is different at several body sites, including mucosal tissues. Read more about this study
- Who is it for?
- Ages 18 to 49 years, men only
- Conditions the study is for
- HIV Infections
- What is being tested?
- Single dose of Genvoya® and a single 800 mg dose of Darunavir®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Apr 2018to 29 Mar 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- 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
- Not currently taking PrEP and no plans to initiate during study
- Not currently taking PEP
- Able to provide informed consent in English
- No plans for relocation in the next 3 months
Show all 9Show fewer
- Willing to undergo peripheral blood, penile swabs, urine, and rectal biopsy sampling
- Willing to use study products as directed
- Willing to abstain from receptive anal intercourse 3 days prior to starting study product and for the duration of the study and for 7 days after any rectal biopsy procedure.
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, including but not limited to:
- Hgb ≤ 10 g/dL
- PTT > 1.5x ULN or INR > 1.5x ULN
- Platelet count <100,000
- Creatinine clearance <60
Show all 24Show fewer
- 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 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 NSAIDs
- Warfarin, heparin (low-molecular weight or unfractionated), platelet aggregation inhibitors, or fibrinolytic agents
- Any form of rectally administered agent besides 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 pre/post-exposure prophylaxis (PrEP or PEP) 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.
About this study
Official title: Body Compartment Pharmacokinetics of Anti-retroviral Agents That May be Used for Future HIV Post-exposure Prophylaxis Regimens.
This study is being conducted to determine if the uptake of anti-HIV medications called Genvoya® and darunavir is different at several body sites, including mucosal tissues.
Read the detailed description
Men who have sex with men (MSM) continue to be disproportionately affected by HIV. The majority of MSM acquire HIV after exposure to the rectal mucosa through unprotected receptive anal intercourse. Post-exposure-prophylaxis (PEP) is an intervention that is used to prevent HIV infection soon (72 hours) after a potential exposure. HIV-negative people with a possible exposure to HIV are instructed to take 28 days of a combination anti-HIV medication regimen, Truvada® + Raltegravir. This study is being conducted to determine if the uptake of other anti-HIV medications called Genvoya® and darunavir is different at several body sites, including mucosal tissues. These other medications might be considered for PEP regimens in the future.
- Conditions
- HIV Infections
- Being tested
- Single dose of Genvoya® and a single 800 mg dose of Darunavir®
- Keywords
- Post-Exposure Prophylaxis, Anti-Retroviral, Pharmacokinetics
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single dose of Genvoya® and a single 800 mg dose of Darunavir®Drug
Men will be instructed to take Single dose of Genvoya® and a single 800 mg dose of Darunavir® per oral
| Study group | Role | What they receive |
|---|---|---|
| Pre- drug | No intervention | Participants will not receive any drug. They will be asked to return 1-6 weeks after the screening visit for study procedures (blood collection, oral cheek swab, penile swabs, urethral swab, rectal swabs, urine sample, and rectal biopsy via rigid sigmoidoscopy. |
| Group A.1 | Experimental | Men will be dosed with Genvoya and Darunavir® on site (time of dose will be recorded) and asked to return in 2 hours, 24 hours (+/- 1 hour), and 72 hours (+/- 1 hour) after taking dose for study procedures (blood collection, oral cheek swab, penile swabs, urethral swab, and a urine sample). Participant will undergo rectal swabs and rectal biopsy via rigid sigmoidoscopy in 2 hours after dosing. Receives: Drug: Single dose of Genvoya® and a single 800 mg dose of Darunavir® |
| Group A.2 | Experimental | Men will be dosed with Genvoya and Darunavir® on site (time of dose will be recorded) and asked to return in 2 hours, 24 hours (+/- 1 hour), and 72 hours (+/- 1 hour) after taking dose for study procedures (blood collection, oral cheek swab, penile swabs, urethral swab, and a urine sample). Participant will undergo rectal swabs and rectal biopsy via rigid sigmoidoscopy in 24 hours after dosing. Receives: Drug: Single dose of Genvoya® and a single 800 mg dose of Darunavir® |
| Group A.3 | Experimental | Men will be dosed with Genvoya and Darunavir® on site (time of dose will be recorded) and asked to return in 2 hours, 24 hours (+/- 1 hour), and 72 hours (+/- 1 hour) after taking dose for study procedures (blood collection, oral cheek swab, penile swabs, urethral swab, and a urine sample). Participant will undergo rectal swabs and rectal biopsy via rigid sigmoidoscopy in 72 hours after dosing. Receives: Drug: Single dose of Genvoya® and a single 800 mg dose of Darunavir® |
| Group B.1 | Experimental | Men will be dosed with Genvoya and Darunavir® on site (time of dose will be recorded) and asked to return in 4 hours, 48 hours (+/- 1 hour), and 96 hours (+/- 1 hour) after taking dose for study procedures (blood collection, oral cheek swab, penile swabs, urethral swab, and a urine sample). Participant will undergo rectal swabs and rectal biopsy via rigid sigmoidoscopy in 4 hours after dosing. Receives: Drug: Single dose of Genvoya® and a single 800 mg dose of Darunavir® |
| Group B.2 | Experimental | Men will be dosed with Genvoya and Darunavir® on site (time of dose will be recorded) and asked to return in 4 hours, 48 hours (+/- 1 hour), and 96 hours (+/- 1 hour) after taking dose for study procedures (blood collection, oral cheek swab, penile swabs, urethral swab, and a urine sample). Participant will undergo rectal swabs and rectal biopsy via rigid sigmoidoscopy in 48 hours after dosing. Receives: Drug: Single dose of Genvoya® and a single 800 mg dose of Darunavir® |
| Group B.3 | Experimental | Men will be dosed with Genvoya and Darunavir® on site (time of dose will be recorded) and asked to return in 4 hours, 48 hours (+/- 1 hour), and 96 hours (+/- 1 hour) after taking dose for study procedures (blood collection, oral cheek swab, penile swabs, urethral swab, and a urine sample). Participant will undergo rectal swabs and rectal biopsy via rigid sigmoidoscopy in 96 hours after dosing. Receives: Drug: Single dose of Genvoya® and a single 800 mg dose of Darunavir® |
| Group C | Experimental | Participants will be given a one- day supply of with Genvoya and Darunavir®. Participants return 8 hours (+/- 30min window), 24 hours (+/- 1 hr), and 48 hours (+/- 1 hour) after taking dose for study procedures (blood collection, oral cheek swab, penile swabs, urethral swab, and a urine sample). Participant will undergo rectal swabs and rectal biopsy via rigid sigmoidoscopy in 8 hours after taking the medication. Receives: Drug: Single dose of Genvoya® and a single 800 mg dose of Darunavir® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median Genvoya plasma concentration
Approximately 24 mL of blood will be drawn to obtain Genvoya plasma concentration (median + range; ng/mL)
Measured: 2 to up to 96 hours after time of dose
Median Darunavir plasma concentration
Approximately 24 mL of blood will be drawn to obtain Darunavir plasma concentration (median + range; ng/mL)
Measured: 2 to up to 96 hours after time of dose
Median Genvoya rectal tissue distribution
Rectal biopsy via rigid sigmoidoscopy will be performed to obtain Genvoya rectal tissue distribution (median + range; ng/mg of tissue).
Measured: 2 to up to 96 hours after time of dose
Median Darunavir rectal tissue distribution
Rectal biopsy via rigid sigmoidoscopy will be performed to obtain Darunavir rectal tissue distribution (median + range; ng/mg of tissue).
Measured: 2 to up to 96 hours after time of dose
Secondary outcomes (4)
Median Genvoya rectal secretion concentration
Rectal swabs for Genvoya rectal secretion concentration (median + range; ng/swab)
Measured: 2 to up to 96 hours after time of dose
Median Darunavir rectal secretion concentration
Rectal swabs for Darunavir rectal secretion concentration (median + range; ng/swab)
Measured: 2 to up to 96 hours after time of dose
Median Genvoya urethral secretion concentration
Urethral swab for Genvoya urethral secretion concentration (median + range; ng/swab)
Measured: 2 to up to 96 hours after time of dose
Median Darunavir urethral secretion concentration
Urethral swab for Darunavir urethral secretion concentration (median + range; ng/swab)
Measured: 2 to up to 96 hours after time of dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2018
- Study start27 Apr 2018
- Primary completion29 Mar 2019
- Study completion29 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies 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 1
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 35 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
- NCT03472963
- Sponsor's protocol ID
- IRB00101179
- Acronym
- PEP2
- Status last verified
- Aug 2020
- First submitted
- 15 Mar 2018
- Last updated
- 28 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Body Compartment Pharmacokinetics of Anti-retroviral Agents That May be Used for Future HIV Post-exposure Prophylaxis Regimens.
- ClinicalTrials.gov ID
- NCT03472963
- Acronym / sponsor ID
- PEP2 / IRB00101179
- Conditions
- HIV Infections
- Keywords
- Post-Exposure Prophylaxis, Anti-Retroviral, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- 27 Apr 2018 (actual)
- Primary completion
- 29 Mar 2019 (actual)
- Study completion
- 29 Mar 2019 (actual)
- First posted
- 21 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being conducted to determine if the uptake of anti-HIV medications called Genvoya® and darunavir is different at several body sites, including mucosal tissues.
Detailed description
Men who have sex with men (MSM) continue to be disproportionately affected by HIV. The majority of MSM acquire HIV after exposure to the rectal mucosa through unprotected receptive anal intercourse. Post-exposure-prophylaxis (PEP) is an intervention that is used to prevent HIV infection soon (72 hours) after a potential exposure. HIV-negative people with a possible exposure to HIV are instructed to take 28 days of a combination anti-HIV medication regimen, Truvada® + Raltegravir. This study is being conducted to determine if the uptake of other anti-HIV medications called Genvoya® and darunavir is different at several body sites, including mucosal tissues. These other medications might be considered for PEP regimens in the future.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Pre- drug | No intervention | –Participants will not receive any drug. They will be asked to return 1-6 weeks after the screening visit for study procedures (blood collection, oral cheek swab, penile swabs, urethral swab, rectal swabs, urine sample, and rectal biopsy via rigid sigmoidoscopy. |
| Group A.1 | Experimental | Drug: Single dose of Genvoya® and a single 800 mg dose of Darunavir®Men will be dosed with Genvoya and Darunavir® on site (time of dose will be recorded) and asked to return in 2 hours, 24 hours (+/- 1 hour), and 72 hours (+/- 1 hour) after taking dose for study procedures (blood collection, oral cheek swab, penile swabs, urethral swab, and a urine sample). Participant will undergo rectal swabs and rectal biopsy via rigid sigmoidoscopy in 2 hours after dosing. |
| Group A.2 | Experimental | Drug: Single dose of Genvoya® and a single 800 mg dose of Darunavir®Men will be dosed with Genvoya and Darunavir® on site (time of dose will be recorded) and asked to return in 2 hours, 24 hours (+/- 1 hour), and 72 hours (+/- 1 hour) after taking dose for study procedures (blood collection, oral cheek swab, penile swabs, urethral swab, and a urine sample). Participant will undergo rectal swabs and rectal biopsy via rigid sigmoidoscopy in 24 hours after dosing. |
| Group A.3 | Experimental | Drug: Single dose of Genvoya® and a single 800 mg dose of Darunavir®Men will be dosed with Genvoya and Darunavir® on site (time of dose will be recorded) and asked to return in 2 hours, 24 hours (+/- 1 hour), and 72 hours (+/- 1 hour) after taking dose for study procedures (blood collection, oral cheek swab, penile swabs, urethral swab, and a urine sample). Participant will undergo rectal swabs and rectal biopsy via rigid sigmoidoscopy in 72 hours after dosing. |
| Group B.1 | Experimental | Drug: Single dose of Genvoya® and a single 800 mg dose of Darunavir®Men will be dosed with Genvoya and Darunavir® on site (time of dose will be recorded) and asked to return in 4 hours, 48 hours (+/- 1 hour), and 96 hours (+/- 1 hour) after taking dose for study procedures (blood collection, oral cheek swab, penile swabs, urethral swab, and a urine sample). Participant will undergo rectal swabs and rectal biopsy via rigid sigmoidoscopy in 4 hours after dosing. |
| Group B.2 | Experimental | Drug: Single dose of Genvoya® and a single 800 mg dose of Darunavir®Men will be dosed with Genvoya and Darunavir® on site (time of dose will be recorded) and asked to return in 4 hours, 48 hours (+/- 1 hour), and 96 hours (+/- 1 hour) after taking dose for study procedures (blood collection, oral cheek swab, penile swabs, urethral swab, and a urine sample). Participant will undergo rectal swabs and rectal biopsy via rigid sigmoidoscopy in 48 hours after dosing. |
| Group B.3 | Experimental | Drug: Single dose of Genvoya® and a single 800 mg dose of Darunavir®Men will be dosed with Genvoya and Darunavir® on site (time of dose will be recorded) and asked to return in 4 hours, 48 hours (+/- 1 hour), and 96 hours (+/- 1 hour) after taking dose for study procedures (blood collection, oral cheek swab, penile swabs, urethral swab, and a urine sample). Participant will undergo rectal swabs and rectal biopsy via rigid sigmoidoscopy in 96 hours after dosing. |
| Group C | Experimental | Drug: Single dose of Genvoya® and a single 800 mg dose of Darunavir®Participants will be given a one- day supply of with Genvoya and Darunavir®. Participants return 8 hours (+/- 30min window), 24 hours (+/- 1 hr), and 48 hours (+/- 1 hour) after taking dose for study procedures (blood collection, oral cheek swab, penile swabs, urethral swab, and a urine sample). Participant will undergo rectal swabs and rectal biopsy via rigid sigmoidoscopy in 8 hours after taking the medication. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Male only
- Healthy volunteers
- Not 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
- Not currently taking PrEP and no plans to initiate during study
- Not currently taking PEP
- Able to provide informed consent in English
Key exclusion criteria (24 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, 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 |
|---|---|---|
| Single dose of Genvoya® and a single 800 mg dose of Darunavir®Men will be instructed to take Single dose of Genvoya® and a single 800 mg dose of Darunavir® per oral | Drug | Group A.1, Group A.2, Group A.3, Group B.1, Group B.2, Group B.3, Group C |
Primary outcome
Median Genvoya plasma concentration
Time frame: 2 to up to 96 hours after time of dose
Approximately 24 mL of blood will be drawn to obtain Genvoya plasma concentration (median + range; ng/mL)
Median Darunavir plasma concentration
Time frame: 2 to up to 96 hours after time of dose
Approximately 24 mL of blood will be drawn to obtain Darunavir plasma concentration (median + range; ng/mL)
Median Genvoya rectal tissue distribution
Time frame: 2 to up to 96 hours after time of dose
Rectal biopsy via rigid sigmoidoscopy will be performed to obtain Genvoya rectal tissue distribution (median + range; ng/mg of tissue).
Median Darunavir rectal tissue distribution
Time frame: 2 to up to 96 hours after time of dose
Rectal biopsy via rigid sigmoidoscopy will be performed to obtain Darunavir rectal tissue distribution (median + range; ng/mg of tissue).
4 secondary outcomes
Median Genvoya rectal secretion concentration
Time frame: 2 to up to 96 hours after time of dose
Median Darunavir rectal secretion concentration
Time frame: 2 to up to 96 hours after time of dose
Median Genvoya urethral secretion concentration
Time frame: 2 to up to 96 hours after time of dose
Median Darunavir urethral secretion concentration
Time frame: 2 to up to 96 hours after time of dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2020.
Related trials for HIV Infections
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 1 study testing Single dose of Genvoya® and a single 800 mg dose of Darunavir® in people with HIV Infections, 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 24 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 28 Aug 2020. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Genvoya plasma concentration (time frame: 2 to up to 96 hours after time of dose). The study lists 4 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 28 Aug 2020.