Serologic Response of SyphilisNCT01944358
Comparisons of Serologic Response of Early Syphilis
An observational study of Serologic Response of Syphilis and Early Syphilis, run by National Taiwan University Hospital at 2 sites in Taiwan.
Trial summary
Syphilis and HIV are prone to occur concomitantly and the two diseases share several modes of acquisition and risk factors such as men who have sex with men (MSM), sexual workers, intravenous drug users, previous history of sexual transmitted diseases (STDs), and multiple partners. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Serologic Response of Syphilis, Early Syphilis, High Risk Behavior
- How many people
- 1,128 participants
- Where
- 2 sitesTaiwan
- Study dates
- Jan 2007to Jun 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: persons aged ≧20 year-old, who had documented syphilis infection (RPR titer≧ 1:4 and TPPA ≧1:320)
Who may be able to join
- persons aged ≧20 year-old, who had documented syphilis infection (RPR titer≧ 1:4 and TPPA ≧1:320)
Who cannot join
- Nil
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites
National Taiwan University Hospital
Taipei, Taiwan, 100
Far Eastern Memorial Hospital
Taipei, Taiwan, 220
About this study
Official title: Comparisons of Treatment Response to Standard Treatment With Penicillin Between HIV-infected and HIV-uninfected Patients With Syphilis
Syphilis and HIV are prone to occur concomitantly and the two diseases share several modes of acquisition and risk factors such as men who have sex with men (MSM), sexual workers, intravenous drug users, previous history of sexual transmitted diseases (STDs), and multiple partners. HIV infection rates of up to 50% have been reported among patients diagnosed with syphilis in several regions, with higher HIV infection rates among MSM. Besides, syphilis ulcers are proposed to enhance the transmission of HIV. In Taiwan, there is also an increasing prevalence of syphilis and HIV co-infection among MSM. Therefore, to treat syphilis is an important issue for public health.
According to literature review, whether patients with HIV and syphilis co-infection had higher serologic failure rate remains controversial, especially in the era after highly active anti-retroviral therapy (HAART) was introduced since 1996. Ghanem et al recently demonstrated that the use of HAART may reduce syphilis failure rates among HIV-infected patients who have syphilis. In addition, the treatment guideline in 2006 suggested that the treatment of primary syphilis and secondary syphilis is single dose benzathine penicillin G regardless of HIV status; however, it goes on to suggest that "some specialists recommended additional treatments for HIV-infected patients", namely 3 doses, each a week apart. There is no reference and evidence of strength of the suggestion but only specialists' opinion.
In the study, we aim to compare serologic response of syphilis to penicillin treatment between HIV-infected and HIV-uninfected patients and to compare serologic response of early syphilis (primary or secondary) to 1 dose and 3 doses of benzathine penicillin G among HIV-infected patients. A longitudinal follow-up of serologic response will be conducted after syphilis treatment.
- Keywords
- Syphilis; human immunodeficiency virus; penicillin
- Medical subject headings
- Syphilis, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Taiwan AIDS study group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare serologic response of HIV-infected patients co-infected with early syphilis who received 1-dose or 3-doses benzathine penicillin G
Measured: Serial analysis every 6 months. From date of enrollment until the date of first documented treatment failure during 12-months follow up or till the complete of 12-month follow. Final accessed till June, 2013.
Secondary outcomes (1)
To compare the serologic response among HIV-infected and uninfected patients after receiving benzathine penicillin G
Measured: Serial analysis every 6 months. From date of enrollment until the date of first documented treatment failure during 12-months follow up or till the complete of 12-month follow. Final accessed till June, 2013.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2013 (estimated)
- Study startJan 2007
- Primary completionJun 2012
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Serologic Response of SyphilisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,128 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Far Eastern Memorial Hospital, Taichung Veterans General Hospital, National Cheng-Kung University Hospital, Chang Gung Memorial Hospital, Chi Mei Medical Hospital, Kaohsiung Medical University Chung-Ho Memorial Hospital, E-DA Hospital
- Responsible party
- Principal investigator, National Taiwan University Hospital, National Taiwan University Hospital
- Investigators
- Chia-Jui Yang, MD, Principal investigator, Far Eastern Memorial HospitalChien-Chin Hung, PHD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01944358
- Sponsor's protocol ID
- NTUH rec 201003111R
- Status last verified
- Sep 2013
- First submitted
- 7 Sep 2013
- Last updated
- 17 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparisons of Treatment Response to Standard Treatment With Penicillin Between HIV-infected and HIV-uninfected Patients With Syphilis
- ClinicalTrials.gov ID
- NCT01944358
- Acronym / sponsor ID
- NTUH rec 201003111R
- Keywords
- Syphilis; human immunodeficiency virus; penicillin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,128 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- Far Eastern Memorial Hospital, Taichung Veterans General Hospital, National Cheng-Kung University Hospital, Chang Gung Memorial Hospital, Chi Mei Medical Hospital, Kaohsiung Medical University Chung-Ho Memorial Hospital, E-DA Hospital
- Study start
- Jan 2007
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 17 Sep 2013 (estimated)
- 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.
Syphilis and HIV are prone to occur concomitantly and the two diseases share several modes of acquisition and risk factors such as men who have sex with men (MSM), sexual workers, intravenous drug users, previous history of sexual transmitted diseases (STDs), and multiple partners. HIV infection rates of up to 50% have been reported among patients diagnosed with syphilis in several regions, with higher HIV infection rates among MSM. Besides, syphilis ulcers are proposed to enhance the transmission of HIV. In Taiwan, there is also an increasing prevalence of syphilis and HIV co-infection among MSM. Therefore, to treat syphilis is an important issue for public health.
According to literature review, whether patients with HIV and syphilis co-infection had higher serologic failure rate remains controversial, especially in the era after highly active anti-retroviral therapy (HAART) was introduced since 1996. Ghanem et al recently demonstrated that the use of HAART may reduce syphilis failure rates among HIV-infected patients who have syphilis. In addition, the treatment guideline in 2006 suggested that the treatment of primary syphilis and secondary syphilis is single dose benzathine penicillin G regardless of HIV status; however, it goes on to suggest that "some specialists recommended additional treatments for HIV-infected patients", namely 3 doses, each a week apart. There is no reference and evidence of strength of the suggestion but only specialists' opinion.
In the study, we aim to compare serologic response of syphilis to penicillin treatment between HIV-infected and HIV-uninfected patients and to compare serologic response of early syphilis (primary or secondary) to 1 dose and 3 doses of benzathine penicillin G among HIV-infected patients. A longitudinal follow-up of serologic response will be conducted after syphilis treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Taiwan AIDS study group | – | – |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- persons aged ≧20 year-old, who had documented syphilis infection (RPR titer≧ 1:4 and TPPA ≧1:320)
Key inclusion criteria (1 listed)
- persons aged ≧20 year-old, who had documented syphilis infection (RPR titer≧ 1:4 and TPPA ≧1:320)
Key exclusion criteria (1 listed)
- Nil
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To compare serologic response of HIV-infected patients co-infected with early syphilis who received 1-dose or 3-doses benzathine penicillin G
Time frame: Serial analysis every 6 months. From date of enrollment until the date of first documented treatment failure during 12-months follow up or till the complete of 12-month follow. Final accessed till June, 2013.
1 secondary outcome
To compare the serologic response among HIV-infected and uninfected patients after receiving benzathine penicillin G
Time frame: Serial analysis every 6 months. From date of enrollment until the date of first documented treatment failure during 12-months follow up or till the complete of 12-month follow. Final accessed till June, 2013.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2013.
Related trials for Serologic Response of Syphilis
Recruiting
Comparisons of Treatment Responses of Early Syphilis to Benzathine Penicillin G With or Without Doxycycline
Early Syphilis, Latent, Serological Relapse After Treatment
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.
Chia-Jui Yang, MD principal investigator
Far Eastern Memorial Hospital
Chien-Chin Hung, PHD principal investigator
National Taiwan University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Serologic Response of Syphilis and Early Syphilis, run by National Taiwan University Hospital at 2 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 1 inclusion and 1 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 17 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To compare serologic response of HIV-infected patients co-infected with early syphilis who received 1-dose or 3-doses benzathine penicillin G (time frame: Serial analysis every 6 months. From date of enrollment until the date of first documented treatment failure during 12-months follow up or till the complete of 12-month follow. Final accessed till June, 2013.). 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 17 Sep 2013.