HIV/AIDSPhase 1NCT03976752
Body Compartment Pharmacokinetics of Anti-retroviral Agents That May be Considered for Future On-demand Peri-exposure HIV Prophylaxis Regimens
A Phase 1 study testing Genvoya in people with HIV/AIDS, 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 medication, called Genvoya®, at different time-frames, is different at several body sites, including mucosal tissues. This medication might be considered for on-demand PEP regimens in the future. Read more about this study
- Who is it for?
- Ages 18 to 49 years, men only
- Conditions the study is for
- HIV/AIDS
- What is being tested?
- Genvoya
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Mar 2019to 20 Sep 2019
- Phase
- Phase 1
- 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
- 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
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- 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.
- Hepatitis B surface antigen (HBsAg) must be negative (screening lab test)
- Creatine clearance >60 ml/min
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
- Currently infected with hepatitis virus and/ or have liver disease
- Current or chronic history of kidney disease
- Significant laboratory abnormalities at baseline visit, including but not limited to:
- Hgb ≤ 10 g/dL
- Partial thromboplastin time (PTT) > 1.5x upper limit of normal (ULN) or international normalized ratio (INR) > 1.5x ULN
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- Platelet count <100,000
- Creatinine clearance <60
- HBsAg reactive
- 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 (short course steroids less than 7 days duration, allowable at the discretion of the investigators)
- 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.
- Participants taking potent inhibitors (e.g. itraconazole, diltiazem) or inducers (e.g. rifampin, phenytoin) of the CYP3A4 enzyme that also metabolizes Genvoya will be excluded from the study
Trial locations and contacts
1 site in 1 country.
About this study
This study is being conducted to determine if the uptake of anti-HIV medication, called Genvoya®, at different time-frames, is different at several body sites, including mucosal tissues. This medication might be considered for on-demand PEP regimens in the future.
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 another anti-HIV medication, called Genvoya®, at different time-frames, is different at several body sites, including mucosal tissues. This medication might be considered for on-demand PEP regimens in the future.
- Conditions
- HIV/AIDS
- Being tested
- Genvoya
- Keywords
- HIV, MSM, Anti-retrovirals, Pharmacokinetics, Peri-exposure HIV 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.
GenvoyaDrug
Also called Cobicistat/Elvitegravir/Emtricitabine/Tenofovir alafenamide
Genvoya is a fixed-dose combination anti-retroviral drug containing tenofovir alafenamide (TAF), emtricitabine (FTC), elvitegravir (EVG), and cobicistat.
At the second study visit, participants will be provided with a single dose of Genvoya, and instructed to take the dose at home with documentation by digital, time-stamped photo or video. At the third study visit, which will occur 24 hours after home dosing, participants will be given another single dose of Genvoya at the clinic.
| Study group | Role | What they receive |
|---|---|---|
| Pre-drug | No intervention | Participants enrolled in the pre-drug arm will not receive any drug. At visit 2, they will undergo blood, urine, penile swab, cheek swab, rectal swab and rectal biopsy collection. |
| Genvoya - 2 and 48 hours specimen collection | Experimental | Specimen collection 2 hours after taking the medication in the clinic (visit 4), and 48 hours after taking the medication in the clinic (visit 5). Receives: Drug: Genvoya |
| Genvoya - 4 and 72 hours specimen collection | Experimental | Specimen collection 4 hours after taking the medication in the clinic (visit 4), and 72 hours after taking the medication in the clinic (visit 5). Receives: Drug: Genvoya |
| Genvoya - 24 and 96 hours specimen collection | Experimental | Specimen collection 24 hours after taking the medication in the clinic (visit 4), and 96 hours after taking the medication in the clinic (visit 5). Receives: Drug: Genvoya |
| Genvoya - Single time point specimen collection | Experimental | Specimen collection 8 hours after taking the medication in the clinic (visit 4). Receives: Drug: Genvoya |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Concentration of Tenofovir (TFV)
Median drug concentrations of the TFV component of Genvoya were determined at baseline and at each of the protocol specified follow-up time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero.
Measured: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication
Plasma Concentration of Emtricitabine (FTC)
Median drug concentrations of the FTC component of Genvoya were determined at baseline and at each of the protocol specified follow-up time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero.
Measured: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication
Plasma Concentration of Elvitegravir (EVG)
Median drug concentrations of the EVG component of Genvoya were determined at baseline and at each of the protocol specified follow-up time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero.
Measured: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication
Secondary outcomes (2)
Peripheral Blood Mononuclear Cell (PBMC) Concentration of Tenofovir-diphosphate (TFV-DP)
A peripheral blood mononuclear cell (PBMC) is any peripheral blood cell having a round nucleus: lymphocytes (T cells, B cells, natural killer (NK) cells) and monocytes. Median drug concentrations were determined at baseline and at each of the protocol specified follow-up time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero.
Measured: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication
Peripheral Blood Mononuclear Cell (PBMC) Concentration of Emtricitabine-triphosphate (FTC-TP)
A peripheral blood mononuclear cell (PBMC) is any peripheral blood cell having a round nucleus: lymphocytes (T cells, B cells, NK cells) and monocytes. Median drug levels were determined at baseline and at each of the protocol specified follow-up time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero.
Measured: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2019
- Study start13 Mar 2019
- Primary completion20 Sep 2019
- Study completion20 Sep 2019
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 HIV/AIDSStudies 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
- 41 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, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03976752
- Sponsor's protocol ID
- IRB00108386
- Status last verified
- Jul 2021
- First submitted
- 4 Jun 2019
- Last updated
- 13 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after de-identification (e.g., text, tables, figures, and appendices), will be available. The study protocol will be available. Data will become available Beginning 9 months and ending at 36 months following publication to researchers who provide a methodologically sound proposal.
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2021. 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 Considered for Future On-demand Peri-exposure HIV Prophylaxis Regimens
- ClinicalTrials.gov ID
- NCT03976752
- Acronym / sponsor ID
- IRB00108386
- Conditions
- HIV/AIDS
- Keywords
- HIV, MSM, Anti-retrovirals, Pharmacokinetics, Peri-exposure HIV prophylaxis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- 13 Mar 2019 (actual)
- Primary completion
- 20 Sep 2019 (actual)
- Study completion
- 20 Sep 2019 (actual)
- First posted
- 6 Jun 2019 (actual)
- Results
- Posted 13 Aug 2021
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 medication, called Genvoya®, at different time-frames, is different at several body sites, including mucosal tissues. This medication might be considered for on-demand PEP regimens in the future.
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 another anti-HIV medication, called Genvoya®, at different time-frames, is different at several body sites, including mucosal tissues. This medication might be considered for on-demand PEP regimens in the future.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Pre-drug | No intervention | –Participants enrolled in the pre-drug arm will not receive any drug. At visit 2, they will undergo blood, urine, penile swab, cheek swab, rectal swab and rectal biopsy collection. |
| Genvoya - 2 and 48 hours specimen collection | Experimental | Drug: GenvoyaSpecimen collection 2 hours after taking the medication in the clinic (visit 4), and 48 hours after taking the medication in the clinic (visit 5). |
| Genvoya - 4 and 72 hours specimen collection | Experimental | Drug: GenvoyaSpecimen collection 4 hours after taking the medication in the clinic (visit 4), and 72 hours after taking the medication in the clinic (visit 5). |
| Genvoya - 24 and 96 hours specimen collection | Experimental | Drug: GenvoyaSpecimen collection 24 hours after taking the medication in the clinic (visit 4), and 96 hours after taking the medication in the clinic (visit 5). |
| Genvoya - Single time point specimen collection | Experimental | Drug: GenvoyaSpecimen collection 8 hours after taking the medication in the clinic (visit 4). |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 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 (28 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
- Currently infected with hepatitis virus and/ or have liver disease
- Current or chronic history of kidney disease
- 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:
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 |
|---|---|---|
| GenvoyaAlso: Cobicistat/Elvitegravir/Emtricitabine/Tenofovir alafenamideGenvoya is a fixed-dose combination anti-retroviral drug containing tenofovir alafenamide (TAF), emtricitabine (FTC), elvitegravir (EVG), and cobicistat. At the second study visit, participants will be provided with a single dose of Genvoya, and instructed to take the dose at home with documentation by digital, time-stamped photo or video. At the third study visit, which will occur 24 hours after home dosing, participants will be given another single dose of Genvoya at the clinic. | Drug | Genvoya - 2 and 48 hours specimen collection, Genvoya - 24 and 96 hours specimen collection, Genvoya - 4 and 72 hours specimen collection, Genvoya - Single time point specimen collection |
Primary outcome
Plasma Concentration of Tenofovir (TFV)
Time frame: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication
Median drug concentrations of the TFV component of Genvoya were determined at baseline and at each of the protocol specified follow-up time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero.
Plasma Concentration of Emtricitabine (FTC)
Time frame: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication
Median drug concentrations of the FTC component of Genvoya were determined at baseline and at each of the protocol specified follow-up time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero.
Plasma Concentration of Elvitegravir (EVG)
Time frame: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication
Median drug concentrations of the EVG component of Genvoya were determined at baseline and at each of the protocol specified follow-up time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero.
2 secondary outcomes
Peripheral Blood Mononuclear Cell (PBMC) Concentration of Tenofovir-diphosphate (TFV-DP)
Time frame: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication
Peripheral Blood Mononuclear Cell (PBMC) Concentration of Emtricitabine-triphosphate (FTC-TP)
Time frame: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after de-identification (e.g., text, tables, figures, and appendices), will be available. The study protocol will be available. Data will become available Beginning 9 months and ending at 36 months following publication to researchers who provide a methodologically sound proposal.
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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 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 Genvoya in people with HIV/AIDS, 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 11 inclusion and 28 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 13 Aug 2021. 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?
Yes. Results are posted in the registry (first posted 13 Aug 2021). 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?
Plasma Concentration of Tenofovir (TFV) (time frame: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication). The study lists 3 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 13 Aug 2021.