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Could adding a common antibiotic beat syphilis in HIV patients?

NCT ID NCT06069141

Disease control Sponsor: National Taiwan University Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 07, 2026 · Updated 2 times

Summary

This study tests whether adding doxycycline to the standard penicillin shot works better for treating early syphilis in people with HIV. About 688 adults will be randomly assigned to get either penicillin alone or penicillin plus a week of doxycycline pills. The main goal is to see if the combination leads to a faster drop in syphilis blood test levels at 24 and 48 weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Benzathine penicillin G and doxycycline
What this could lead to
If successful, this could lead to a more effective treatment regimen for early syphilis in people living with HIV, reducing relapse and transmission.
What could go wrong
This is a relatively small, early-stage study. The added benefit of doxycycline may be modest, and side effects or antibiotic resistance could limit its use.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 688 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2024

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * People living with HIV (PLWH) aged ≥18 years with early syphilis * Confirmed by a positive RPR titer with a reactive TPPA assay Exclusion Criteria: * 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

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Conditions

The condition(s) this trial relates to.

latent early syphilis primary syphilis syphilis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Early syphilis, latent, serological relapse after treatment

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    9 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Chi Mei Medical Hospital

    RECRUITING

    Tainan, Taiwan

  • Far Eastern Memorial Hospital

    RECRUITING

    Taipei, Taiwan, 110, Taiwan

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    RECRUITING

    Kaohsiung City, Taiwan

  • Kaohsiung Veterans General Hospital

    RECRUITING

    Kaohsiung City, Taiwan

  • National Cheng-Kung University Hospital

    RECRUITING

    Tainan, Taiwan

  • National Taiwan University Hospital

    RECRUITING

    Taipei, Taiwan, 110, Taiwan

  • National Taiwan University Hospital Hsin-Chu Branch

    RECRUITING

    Hsinchu, Taiwan, 110, Taiwan

  • Taipei Vetetrans General Hospital

    RECRUITING

    Taipei, Taiwan, 110, Taiwan

  • Taoyuan General Hospital

    RECRUITING

    Taoyuan, Taiwan, 110, Taiwan

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