Human Immunodeficiency VirusPhase 4NCT04298697
Biomarkers for Event-driven PrEP Adherence
A Phase 4 study testing Tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) in people with Human Immunodeficiency Virus, run by Emory University at 1 site in United States.
Trial summary
This study aims to recruit 40 participants who will take the combination anti-HIV drug tenofovir+emtricitabine (TDF/FTC) at specified times. Participants will then provide biologic samples for the measurement of anti-retroviral drug concentrations in various body compartment sites. Read more about this study
- Who is it for?
- Ages 18 to 59 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Human Immunodeficiency Virus
- What is being tested?
- Tenofovir disoproxil fumarate/emtricitabine (TDF/FTC)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Feb 2020to 9 Aug 2022
- 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 59 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- HIV-negative person, who was assigned male at birth, who reports sex with another man in the last year, and is in good general health.
- Not currently taking PrEP and no plans to initiate during study
- Not currently taking PEP
- Consistent condom use and willing to use condoms for the duration of the study
- Able to provide informed consent in English
- No plans for relocation in the next 4 months
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- Willing to undergo peripheral blood, urine, hair, finger stick, and optional hair sampling
- Willing to use study products as directed
- Hepatitis B surface antigen (HBsAg) must be negative (screening lab test)
- Creatinine clearance (CrCl) >60 ml/min
Who cannot join
- Currently infected with hepatitis virus and/ or has liver disease
- Current or chronic history of kidney disease or CrCl<60 ml/min
- 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)
- Chemotherapy or radiation for treatment of malignancy
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- 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
- 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
This study aims to recruit 40 participants who will take the combination anti-HIV drug tenofovir+emtricitabine (TDF/FTC) at specified times. Participants will then provide biologic samples for the measurement of anti-retroviral drug concentrations in various body compartment sites. Participants will be involved in the study for up to 24 weeks.
Read the detailed description
Men who have sex with men (MSM) continue to be disproportionately affected by HIV. In 2014, MSM made up approximately 2% of the U.S. population but accounted for 70% of the new HIV infections. The majority of MSM acquire HIV after exposure to the rectal mucosa through receptive anal intercourse without condoms. Pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP) are recommended for MSM who may be exposed to HIV to prevent infection. Current recommendations for PrEP are to take the combination anti-HIV drug, tenofovir+emtricitabine (TDF/FTC), on a daily basis for the duration of someone's HIV risk exposure period, which could be months or years. For PEP, a three-drug anti-HIV medication is recommended within 72 hours of a possible exposure for a 28-day course. While PrEP and PEP are effective, some people find it difficult to follow the recommended regimen. Therefore, additional short-course dosing regimens for PrEP and PEP are being implemented, such as on-demand or event-driven PrEP (ED-PrEP). This dosing regimen has patients take two doses of PrEP 2 to 24 hours before sex, one dose 24 hours after sex, and another dose 48 hours after sex. This study seeks to evaluate the usefulness of biomarkers to confirm self-reported adherence to ED-PrEP in MSM. The study drug provided in this study will not protect participants from HIV or treat any active infection.
This study will recruit 40 HIV-negative MSM aged 18-59 in good general health. Participants will be sequentially assigned to one of four study arms which will determine when they will take doses of the study drug and give specimen samples. All participants will provide written informed consent at the first study visit and undergo a screening medical history, physical exam, and safety laboratory tests. All participants will take at least 4 doses (pills) of the study drug. At study visits, participants will return to donate blood, hair, and urine samples, and a finger stick. All biologic specimens collected will be transferred to the Centers for Disease Control and Prevention (CDC) on the day of collection for measurement of drug levels.
- Conditions
- Human Immunodeficiency Virus
- Being tested
- Tenofovir disoproxil fumarate/emtricitabine (TDF/FTC)
- Keywords
- Pre-exposure prophylaxis (PrEP), Post-exposure prophylaxis (PEP)
- 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.
Tenofovir disoproxil fumarate/emtricitabine (TDF/FTC)Drug
Also called Truvada
TDF/FTC is a combination anti-HIV medication that contains the drugs tenofovir disoproxil fumarate (300 mg) and emtricitabine (200 mg). Participants will take 2 pills on the first day of the week and one pill per day on the second and third days of the week, according to the dosing schedule of the study arm they are in. Participants will have biologic specimens collected at specific time points until 28 days after the last dose.
| Study group | Role | What they receive |
|---|---|---|
| TDF/FTC for 1 week | Experimental | The first 10 participants (Arm A) will take TDF/FTC for three consecutive days of one week, taking 2 pills on the first day and one pill on the second and third day, for a total of 4 doses. Receives: Drug: Tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) |
| TDF/FTC for 13 weeks | Experimental | The second 10 participants (Arm B) will take TDF/FTC for three consecutive days for thirteen weeks, taking 2 pills on the first day and one pill on the second and third day of each week, for a total of 52 doses. Receives: Drug: Tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) |
| TDF/FTC for 13 weeks with weekly alternating schedule | Experimental | The third 10 participants (Arm C) will take TDF/FTC for three consecutive days, alternating weeks over a 13-week period, taking 2 pills on the first day and one pill on the second and third day of each dosing week, for a total of 28 doses. Receives: Drug: Tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) |
| TDF/FTC for 13 weeks with weekly alternating schedule every two weeks | Experimental | The fourth 10 participants (Arm D) will take TDF/FTC for three consecutive days over a 13-week period, alternating two weeks of study medication followed by two weeks with no medication, taking 2 pills on the first day and one pill on the second and third day of dosing each week, for a total of 28 doses. Receives: Drug: Tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tenofovir-diphosphate (TFV-DP) Concentration
Concentration of TFV-DP was measured 24 hours after the last dose to compare accumulation of drug following weekly event-driven PrEP (ED-PrEP) dosing. Dried blood spot samples were collected from participants using a 6 millimeter (mm) dried blood spot card punch system.
Measured: 24 Hours After Last Dose (Week 1 for Arm A, Week 13 for Arms B, C, and D)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2020
- Study start28 Feb 2020
- Primary completion9 Aug 2022
- Study completion9 Aug 2022
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 Human Immunodeficiency VirusStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 43 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
- NCT04298697
- Sponsor's protocol ID
- IRB00116781
- Other IDs
- CDC-IRB00116781
- Status last verified
- Aug 2024
- First submitted
- 4 Mar 2020
- Last updated
- 19 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- 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 made available for sharing.
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers for Event-driven PrEP Adherence
- ClinicalTrials.gov ID
- NCT04298697
- Acronym / sponsor ID
- IRB00116781
- Conditions
- Human Immunodeficiency Virus
- Keywords
- Pre-exposure prophylaxis (PrEP), Post-exposure prophylaxis (PEP)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- 28 Feb 2020 (actual)
- Primary completion
- 9 Aug 2022 (actual)
- Study completion
- 9 Aug 2022 (actual)
- First posted
- 6 Mar 2020 (actual)
- Results
- Posted 19 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to recruit 40 participants who will take the combination anti-HIV drug tenofovir+emtricitabine (TDF/FTC) at specified times. Participants will then provide biologic samples for the measurement of anti-retroviral drug concentrations in various body compartment sites. Participants will be involved in the study for up to 24 weeks.
Detailed description
Men who have sex with men (MSM) continue to be disproportionately affected by HIV. In 2014, MSM made up approximately 2% of the U.S. population but accounted for 70% of the new HIV infections. The majority of MSM acquire HIV after exposure to the rectal mucosa through receptive anal intercourse without condoms. Pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP) are recommended for MSM who may be exposed to HIV to prevent infection. Current recommendations for PrEP are to take the combination anti-HIV drug, tenofovir+emtricitabine (TDF/FTC), on a daily basis for the duration of someone's HIV risk exposure period, which could be months or years. For PEP, a three-drug anti-HIV medication is recommended within 72 hours of a possible exposure for a 28-day course. While PrEP and PEP are effective, some people find it difficult to follow the recommended regimen. Therefore, additional short-course dosing regimens for PrEP and PEP are being implemented, such as on-demand or event-driven PrEP (ED-PrEP). This dosing regimen has patients take two doses of PrEP 2 to 24 hours before sex, one dose 24 hours after sex, and another dose 48 hours after sex. This study seeks to evaluate the usefulness of biomarkers to confirm self-reported adherence to ED-PrEP in MSM. The study drug provided in this study will not protect participants from HIV or treat any active infection.
This study will recruit 40 HIV-negative MSM aged 18-59 in good general health. Participants will be sequentially assigned to one of four study arms which will determine when they will take doses of the study drug and give specimen samples. All participants will provide written informed consent at the first study visit and undergo a screening medical history, physical exam, and safety laboratory tests. All participants will take at least 4 doses (pills) of the study drug. At study visits, participants will return to donate blood, hair, and urine samples, and a finger stick. All biologic specimens collected will be transferred to the Centers for Disease Control and Prevention (CDC) on the day of collection for measurement of drug levels.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| TDF/FTC for 1 week | Experimental | Drug: Tenofovir disoproxil fumarate/emtricitabine (TDF/FTC)The first 10 participants (Arm A) will take TDF/FTC for three consecutive days of one week, taking 2 pills on the first day and one pill on the second and third day, for a total of 4 doses. |
| TDF/FTC for 13 weeks | Experimental | Drug: Tenofovir disoproxil fumarate/emtricitabine (TDF/FTC)The second 10 participants (Arm B) will take TDF/FTC for three consecutive days for thirteen weeks, taking 2 pills on the first day and one pill on the second and third day of each week, for a total of 52 doses. |
| TDF/FTC for 13 weeks with weekly alternating schedule | Experimental | Drug: Tenofovir disoproxil fumarate/emtricitabine (TDF/FTC)The third 10 participants (Arm C) will take TDF/FTC for three consecutive days, alternating weeks over a 13-week period, taking 2 pills on the first day and one pill on the second and third day of each dosing week, for a total of 28 doses. |
| TDF/FTC for 13 weeks with weekly alternating schedule every two weeks | Experimental | Drug: Tenofovir disoproxil fumarate/emtricitabine (TDF/FTC)The fourth 10 participants (Arm D) will take TDF/FTC for three consecutive days over a 13-week period, alternating two weeks of study medication followed by two weeks with no medication, taking 2 pills on the first day and one pill on the second and third day of dosing each week, for a total of 28 doses. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- HIV-negative person, who was assigned male at birth, who reports sex with another man in the last year, and is in good general health.
- Not currently taking PrEP and no plans to initiate during study
- Not currently taking PEP
- Consistent condom use and willing to use condoms for the duration of the study
- Able to provide informed consent in English
Key exclusion criteria (10 listed)
- Currently infected with hepatitis virus and/ or has liver disease
- Current or chronic history of kidney disease or CrCl<60 ml/min
- Continued need for, or use during the 90 days prior to enrollment, of the following medications:
- Intent to use HIV antiretroviral pre/post-exposure prophylaxis (PrEP or PEP) during the study, outside of the study procedures
- Current use of hormonal therapy
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 |
|---|---|---|
| Tenofovir disoproxil fumarate/emtricitabine (TDF/FTC)Also: TruvadaTDF/FTC is a combination anti-HIV medication that contains the drugs tenofovir disoproxil fumarate (300 mg) and emtricitabine (200 mg). Participants will take 2 pills on the first day of the week and one pill per day on the second and third days of the week, according to the dosing schedule of the study arm they are in. Participants will have biologic specimens collected at specific time points until 28 days after the last dose. | Drug | TDF/FTC for 1 week, TDF/FTC for 13 weeks, TDF/FTC for 13 weeks with weekly alternating schedule, TDF/FTC for 13 weeks with weekly alternating schedule every two weeks |
Primary outcome
Tenofovir-diphosphate (TFV-DP) Concentration
Time frame: 24 Hours After Last Dose (Week 1 for Arm A, Week 13 for Arms B, C, and D)
Concentration of TFV-DP was measured 24 hours after the last dose to compare accumulation of drug following weekly event-driven PrEP (ED-PrEP) dosing. Dried blood spot samples were collected from participants using a 6 millimeter (mm) dried blood spot card punch system.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- 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 made available for sharing.
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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, 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 Tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) in people with Human Immunodeficiency Virus, 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 10 inclusion and 10 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 Sep 2024. 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 Sep 2024). 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?
Tenofovir-diphosphate (TFV-DP) Concentration (time frame: 24 Hours After Last Dose (Week 1 for Arm A, Week 13 for Arms B, C, and D)). 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 Sep 2024.