Early Syphilis, Latent, Serological Relapse After TreatmentNCT06069141
Comparisons of Treatment Responses of Early Syphilis to Benzathine Penicillin G With or Without Doxycycline
A study testing Benzathine Penicillin G and Doxycycline Capsule in people with Early Syphilis, Latent, Serological Relapse After Treatment, run by National Taiwan University Hospital at 9 sites in Taiwan.
Trial summary
This randomized controlled superiority study will be conducted during 2023-2025. The eligible participants are adult people living with HIV (PLWH) who are newly diagnosed with early syphilis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Early Syphilis, Latent, Serological Relapse After Treatment
- What is being tested?
- Benzathine Penicillin G and Doxycycline Capsule
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 688 participants
- Where
- 9 sitesTaiwan
- Study dates
- 1 Jan 2024to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- People living with HIV (PLWH) aged ≥18 years with early syphilis
- Confirmed by a positive RPR titer with a reactive TPPA assay
Who cannot join
- PWH with RPR titers of <4
- Subject has latent syphilis of unknown duration, late latent syphilis, or evidence of neurosyphilis, including ocular involvement.
- Exposure to antibiotics with activity against T. pallidum within the preceding 4 weeks (penicillin, 3rd cephalosporin, doxycycline, macrolides)
- A known or suspected infection requiring additional treatment with an antimicrobial active against T. pallidum at baseline (penicillin, 3rd cephalosporin, doxycycline, macrolides)
- A history of intolerance to penicillin or doxycycline
- PLWH have already participated in this study
- Pregnancy
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
Taiwan9 sites, 9 recruiting
- Recruiting
National Taiwan University Hospital Hsin-Chu Branch
Hsinchu, Taiwan, 110
Kai-Hsiang Chen, +886-975607715, ted8019@gmail.com
- Recruiting
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City
Po-Liang Lu, +886-975607715, idpaul@gmail.com
- Recruiting
Kaohsiung Veterans General Hospital
Kaohsiung City
Ya-Wei Weng, +886-975607715, weicolchicum@gmail.com
- Recruiting
Chi Mei Medical Hospital
Tainan
Hung-Jen Tang, +886-975607715, 8409d1@gmail.com
- Recruiting
National Cheng-Kung University Hospital
Tainan
Chin-Shiang Tsai, +886-975607715, jasonmammal@gmail.com
- Recruiting
Far Eastern Memorial Hospital
Taipei, Taiwan, 110
Chia-Hui Yang, +886-975607715, yangcj1206@gmail.com
Kuan-Yin Lin
- Recruiting
National Taiwan University Hospital
Taipei, Taiwan, 110
Kuan-Yin Lin, 886-975-607715, kuanyin0828@gmail.com
- Recruiting
Taipei Vetetrans General Hospital
Taipei, Taiwan, 110
Po-Liang Chen, +886-975607715, ajcpmd@gmail.com
- Recruiting
Taoyuan General Hospital
Taoyuan, Taiwan, 110
Cheng-pin Chen, +886-975607715, jangbin@gmail.com
About this study
Official title: Comparisons of Treatment Responses of Early Syphilis to 2.4 Milliunits (MU) Single-dose Benzathine Penicillin G With or Without Doxycycline in People Living With HIV
This randomized controlled superiority study will be conducted during 2023-2025. The eligible participants are adult people living with HIV (PLWH) who are newly diagnosed with early syphilis. Participants will be randomized in a 1:1 ratio to receive single-dose benzathine penicillin G (BPG) (2.4 MU intramuscularly once) plus doxycycline (100 mg orally twice daily for 7 days) or single-dose BPG. The primary outcome is serologic response, defined as a decline of rapid plasma reagin (RPR) titer by 4-fold or greater, at week 24 and week 48; and the secondary outcomes include microbiologic response of syphilis and bacterial sexually transmitted infections (STIs) assessed by nucleic-acid amplification test (NAAT) at week 4.
- Being tested
- Benzathine Penicillin G, Doxycycline Capsule
- Keywords
- syphilis, rapid plasma reagin
- Medical subject headings
- Syphilis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Benzathine Penicillin GDrug
Benzathine Penicillin G (2.4 MU intramuscularly once)
Doxycycline CapsuleDrug
doxycycline (100 mg orally twice daily for 7 days)
| Study group | Role | What they receive |
|---|---|---|
| single-dose BPG plus doxycycline | Active comparator | single-dose benzathine penicillin G (2.4 MU intramuscularly once) plus doxycycline (100 mg orally twice daily for 7 days) Receives: Drug: Benzathine Penicillin G; Drug: Doxycycline Capsule |
| single-dose BPG | Placebo comparator | single-dose benzathine penicillin G (2.4 MU intramuscularly once) Receives: Drug: Benzathine Penicillin G |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serologic response
Either a 4-fold or greater decline in RPR titer compared to baseline or being RPR-nonreactive
Measured: Weeks 24 and week 48
Secondary outcomes (4)
Microbiologic response of syphilis
- pallidum PCR Ct value >38
Measured: Week 4
Microbiologic response of bacterial STIs
negative STI PCR results
Measured: Week 4
Safety of study treatment
Measured: Week 4
Adherence evaluation of tablet intake
Measured: Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2023
- Study start1 Jan 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Syphilis, Latent, Serological Relapse After TreatmentStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 688 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Taiwan University Hospital Hsin-Chu Branch, Far Eastern Memorial Hospital, Taipei Veterans General Hospital, Taiwan, Taoyuan General Hospital, National Cheng-Kung University Hospital, Chi Mei Medical Hospital, Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung Veterans General Hospital.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06069141
- Sponsor's protocol ID
- 202305061MINA
- Status last verified
- Oct 2025
- First submitted
- 1 Oct 2023
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparisons of Treatment Responses of Early Syphilis to 2.4 Milliunits (MU) Single-dose Benzathine Penicillin G With or Without Doxycycline in People Living With HIV
- ClinicalTrials.gov ID
- NCT06069141
- Acronym / sponsor ID
- 202305061MINA
- Keywords
- syphilis, rapid plasma reagin
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 688 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- National Taiwan University Hospital Hsin-Chu Branch, Far Eastern Memorial Hospital, Taipei Veterans General Hospital, Taiwan, Taoyuan General Hospital, National Cheng-Kung University Hospital, Chi Mei Medical Hospital, Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung Veterans General Hospital.
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 5 Oct 2023 (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 randomized controlled superiority study will be conducted during 2023-2025. The eligible participants are adult people living with HIV (PLWH) who are newly diagnosed with early syphilis. Participants will be randomized in a 1:1 ratio to receive single-dose benzathine penicillin G (BPG) (2.4 MU intramuscularly once) plus doxycycline (100 mg orally twice daily for 7 days) or single-dose BPG. The primary outcome is serologic response, defined as a decline of rapid plasma reagin (RPR) titer by 4-fold or greater, at week 24 and week 48; and the secondary outcomes include microbiologic response of syphilis and bacterial sexually transmitted infections (STIs) assessed by nucleic-acid amplification test (NAAT) at week 4.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| single-dose BPG plus doxycycline | Active comparator | Drug: Benzathine Penicillin G, Drug: Doxycycline Capsulesingle-dose benzathine penicillin G (2.4 MU intramuscularly once) plus doxycycline (100 mg orally twice daily for 7 days) |
| single-dose BPG | Placebo comparator | Drug: Benzathine Penicillin Gsingle-dose benzathine penicillin G (2.4 MU intramuscularly once) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- People living with HIV (PLWH) aged ≥18 years with early syphilis
- Confirmed by a positive RPR titer with a reactive TPPA assay
Key exclusion criteria (7 listed)
- PWH with RPR titers of <4
- Subject has latent syphilis of unknown duration, late latent syphilis, or evidence of neurosyphilis, including ocular involvement.
- Exposure to antibiotics with activity against T. pallidum within the preceding 4 weeks (penicillin, 3rd cephalosporin, doxycycline, macrolides)
- A known or suspected infection requiring additional treatment with an antimicrobial active against T. pallidum at baseline (penicillin, 3rd cephalosporin, doxycycline, macrolides)
- A history of intolerance to penicillin or doxycycline
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 |
|---|---|---|
| Benzathine Penicillin GBenzathine Penicillin G (2.4 MU intramuscularly once) | Drug | single-dose BPG, single-dose BPG plus doxycycline |
| Doxycycline Capsuledoxycycline (100 mg orally twice daily for 7 days) | Drug | single-dose BPG plus doxycycline |
Primary outcome
Serologic response
Time frame: Weeks 24 and week 48
Either a 4-fold or greater decline in RPR titer compared to baseline or being RPR-nonreactive
4 secondary outcomes
Microbiologic response of syphilis
Time frame: Week 4
Microbiologic response of bacterial STIs
Time frame: Week 4
Safety of study treatment
Time frame: Week 4
Adherence evaluation of tablet intake
Time frame: Week 4
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Individual participant dataSharing planned: No
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.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Benzathine Penicillin G and Doxycycline Capsule in people with Early Syphilis, Latent, Serological Relapse After Treatment, run by National Taiwan University Hospital at 9 sites in Taiwan.
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 2 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Taiwan. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kuan-Yin Lin, MD (+886-975607715, kuanyin0828@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serologic response (time frame: Weeks 24 and week 48). 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 6 Aug 2026.