Sexually Transmitted DiseasesPhase 4NCT04860505

Combo-PEP: Multipurpose Prevention of Post-Exposure Prophylaxis Regimens

A Phase 4 study testing Doxycycline and Biktarvy in people with Sexually Transmitted Diseases, run by Emory University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The study will determine tissue pharmacology of a single dose of doxycycline for sexually transmitted infection (STI) Post-exposure Prophylaxis (PEP). Read more about this study

Who is it for?: Ages 18 to 59 yearsHealthy volunteers can take part
Conditions the study is for: Sexually Transmitted Diseases
What is being tested?: Doxycycline and Biktarvy
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteUnited States
Study dates: 20 May 2021to 9 May 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
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

HIV negative person, who was assigned male or female at birth, who reports sex with another man in the last year and is in good general health
Aged 18-59 years
Not currently taking PrEP and no plans to initiate during study
Not currently taking PEP
Not currently taking doxycycline or other tetracycline-derived antibiotics and no plans to initiate during the study
Willing to use condoms consistently for the duration of the study

Show all 12Show fewer

Able to provide informed consent in English
No plans for relocation in the next 4 months
Willing to undergo peripheral blood, urine, rectal or vaginal secretion collection, and a rectal or vaginal and cervical biopsy procedure
Willing to use study products as directed
Hepatitis B surface antigen (HBsAg) negative (screening lab test)
Creatinine clearance >60 ml/min

Who cannot join

Currently infected with hepatitis virus and/ or has liver disease
Current or chronic history of kidney disease or creatinine clearance (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

Show all 12Show fewer

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
Intent to use doxycycline or other tetracycline-derived antibiotics during the course of the study, outside of the study procedures
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
Not pregnant and no plans on getting pregnant throughout the duration of the study
Known allergic reaction to study drugs

Trial locations and contacts

1 site in 1 country.

United States1 site

Hope Clinic
Atlanta, Georgia, 30322

Other trials in United States

About this study

The study will determine tissue pharmacology of a single dose of doxycycline for sexually transmitted infection (STI) Post-exposure Prophylaxis (PEP).

Read the detailed description

To determine tissue pharmacology of a single dose of doxycycline for STI PEP, investigators at Emory University will collaborate with the Centers for Disease Control and Prevention (CDC) to conduct a clinical trial of up to 20 men who have sex with men (MSM) and women aged 18-59, with measurement of anti-retroviral drug and doxycycline concentrations in the rectum and vaginal regions.

Conditions: Sexually Transmitted Diseases
Being tested: Doxycycline, Biktarvy
Keywords: Post-Exposure Prophylaxis, HIV, STI, PEP, Prevention
Medical subject headings: Sexually Transmitted Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DoxycyclineDrug
Doxycycline (DOX [200 mg]) is an oral medication used to treat or prevent infections that are strongly suspected to be caused by bacteria; it is an antimicrobial drug indicated for bacterial infections such as sexually transmitted infections.
BiktarvyDrug
Biktarvy (200mg) is an oral combination anti-HIV medication that contains the drugs tenofovir alafenamide, emtricitabine, and bictegravir.

Study groups in NCT04860505
Study group	Role	What they receive
Doxycycline and Biktarvy	Experimental	Participants will take both study drugs simultaneously at home approximately 1 hour before Visit 2 and will be instructed to take a timestamped photograph or videotape of themselves taking the dose. Receives: Drug: Doxycycline; Drug: Biktarvy

What is being measured

The primary outcome is the main question the study is designed to answer.

Rectal Doxycycline Concentration
Doxycycline concentration in tissue from a rectal biopsy was measured. Rectal biopsies were obtained from men. Women had the option to provide a rectal tissue sample.
Measured: 24 hours after a single dose
Vaginal Doxycycline Concentration
Doxycycline concentration in tissue from a vaginal biopsy was measured.
Measured: 24 hours after a single dose
Plasma Doxycycline Concentration
Doxycycline concentration in plasma was measured.
Measured: 24 hours after a single dose

Secondary outcomes (2)

Rectal Bictegravir Concentration
Bectegravir concentration in tissue from a rectal biopsy was measured.
Measured: 24 hours after a single dose
Vaginal Bictegravir Concentration
Bictegravir concentration in tissue from a vaginal biopsy was measured.
Measured: 24 hours after a single dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 May 20219 May 2022

First posted27 Apr 2021
Study start20 May 2021
Primary completion9 May 2022
Study completion9 May 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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Sexually Transmitted DiseasesStudies 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04860505
Sponsor's protocol ID: STUDY00002242
Other IDs: 0000058968
Status last verified: Apr 2023
First submitted: 22 Apr 2021
Last updated: 23 May 2023
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 published for this study (including text, tables, figures, and appendices), will be made available for sharing, after de-identification.

Publications

Daly MB, Spandau M, Edwards TE, Dinh C, Fountain J, Dienhart JA, Conway-Washington C, Kelley C, Heneine W, Haaland R. Chelating anticoagulants reduce plasma doxycycline measurements: implications for doxy PEP monitoring. Expert Rev Clin Pharmacol. 2026 Jan-Feb;19(2):199-205. doi: 10.1080/17512433.2026.2632931. Epub 2026 Feb 19.
PubMed 41701614

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Sexually Transmitted Diseases trials

Study at a glance

From the registry record, last updated by the sponsor on 23 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Combo-PEP: Multipurpose Prevention of Post-Exposure Prophylaxis Regimens
ClinicalTrials.gov ID: NCT04860505
Acronym / sponsor ID: STUDY00002242
Conditions: Sexually Transmitted Diseases
Keywords: Post-Exposure Prophylaxis, HIV, STI, PEP, Prevention
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Emory UniversityUniversity, hospital or other
Collaborators: Centers for Disease Control and Prevention
Study start: 20 May 2021 (actual)
Primary completion: 9 May 2022 (actual)
Study completion: 9 May 2022 (actual)
First posted: 27 Apr 2021 (actual)
Results: Posted 23 May 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The study will determine tissue pharmacology of a single dose of doxycycline for sexually transmitted infection (STI) Post-exposure Prophylaxis (PEP).

Detailed description

Study design

Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Doxycycline and Biktarvy	Experimental	Drug: Doxycycline, Drug: BiktarvyParticipants will take both study drugs simultaneously at home approximately 1 hour before Visit 2 and will be instructed to take a timestamped photograph or videotape of themselves taking the dose.

Who may qualify

Ages: 18 to 59 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (12 listed)

HIV negative person, who was assigned male or female at birth, who reports sex with another man in the last year and is in good general health
Aged 18-59 years
Not currently taking PrEP and no plans to initiate during study
Not currently taking PEP
Not currently taking doxycycline or other tetracycline-derived antibiotics and no plans to initiate during the study

Key exclusion criteria (12 listed)

Currently infected with hepatitis virus and/ or has liver disease
Current or chronic history of kidney disease or creatinine clearance (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
Intent to use doxycycline or other tetracycline-derived antibiotics during the course of the study, outside of the study procedures

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
DoxycyclineDoxycycline (DOX [200 mg]) is an oral medication used to treat or prevent infections that are strongly suspected to be caused by bacteria; it is an antimicrobial drug indicated for bacterial infections such as sexually transmitted infections.	Drug	Doxycycline and Biktarvy
BiktarvyBiktarvy (200mg) is an oral combination anti-HIV medication that contains the drugs tenofovir alafenamide, emtricitabine, and bictegravir.	Drug	Doxycycline and Biktarvy

Primary outcome

Rectal Doxycycline Concentration
Time frame: 24 hours after a single dose
Doxycycline concentration in tissue from a rectal biopsy was measured. Rectal biopsies were obtained from men. Women had the option to provide a rectal tissue sample.
Vaginal Doxycycline Concentration
Time frame: 24 hours after a single dose
Doxycycline concentration in tissue from a vaginal biopsy was measured.
Plasma Doxycycline Concentration
Time frame: 24 hours after a single dose
Doxycycline concentration in plasma was measured.

2 secondary outcomes

Rectal Bictegravir Concentration
Time frame: 24 hours after a single dose
Vaginal Bictegravir Concentration
Time frame: 24 hours after a single dose

Results and safety

Results posted to the registry on 23 May 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Doxycycline and Biktarvy	20	18

Primary outcome: Rectal Doxycycline Concentration

Time frame: 24 hours after a single dose. Median (Full Range). Unit: µg/g

Measure	Doxycycline and Biktarvy n = 15
Value	0.654 (0.305 to 1.237)

Population analysed: This analysis includes participants who completed the rectal biopsy during the 24-hours post-dose visit. Ten men and 5 women provided rectal tissue samples at the 24-hours post-dose visit. One male attended the visit but was not able to tolerate the biopsy procedure and no rectal tissue was obtained.

Primary outcome: Vaginal Doxycycline Concentration

Time frame: 24 hours after a single dose. Median (Full Range). Unit: µg/g

Measure	Doxycycline and Biktarvy n = 8
Value	0.367 (0.203 to 1.445)

Population analysed: One female attended the visit 24 hours post-dose but was not able to proceed with the vaginal biopsy procedure due to menses and vaginal rugae.

Primary outcome: Plasma Doxycycline Concentration

Time frame: 24 hours after a single dose. Median (Full Range). Unit: µg/mL

Measure	Doxycycline and Biktarvy n = 20
Value	487 (305 to 824)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Information on adverse events was collected beginning at the time of enrollment until the participants completed the study or withdrew from the study, up to 7 days.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Doxycycline and Biktarvy	0 of 20 (0%)	0 of 20 (0%)	0 of 20

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41701614Daly MB, Spandau M, Edwards TE, Dinh C, Fountain J, Dienhart JA, Conway-Washington C, Kelley C, Heneine W, Haaland R. Chelating anticoagulants reduce plasma doxycycline measurements: implications for doxy PEP monitoring. Expert Rev Clin Pharmacol. 2026 Jan-Feb;19(2):199-205. doi: 10.1080/17512433.2026.2632931. Epub 2026 Feb 19.
Individual participant dataSharing planned: Yes. Individual participant data that underlie the results published for this study (including text, tables, figures, and appendices), will be made available for sharing, after de-identification.

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Not yet recruitingPhase 2
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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 Doxycycline and Biktarvy in people with Sexually Transmitted Diseases, 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 12 inclusion and 12 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 23 May 2023. 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 23 May 2023). 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?

Rectal Doxycycline Concentration (time frame: 24 hours after a single dose). 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?

On the ClinicalTrials.gov record for NCT04860505, which also lists 1 linked publication.

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 23 May 2023.