Clinical trial NCT01944358: Comparisons of Serologic Response of Early Syphilis
Official title: Comparisons of Treatment Response to Standard Treatment With Penicillin Between HIV-infected and HIV-uninfected Patients With Syphilis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Serologic Response of Syphilis
Early Syphilis
High Risk Behavior
Keywords: Syphilis; human immunodeficiency virus; penicillin
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: Far Eastern Memorial Hospital
name: Taichung Veterans General Hospital
name: National Cheng-Kung University Hospital
name: Chang Gung Memorial Hospital
name: Chi Mei Medical Hospital
name: Kaohsiung Medical University Chung-Ho Memorial Hospital
name: E-DA Hospital
First posted: 2013-09-17
Enrollment: 1128
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: persons aged ≧20 year-old, who had documented syphilis infection (RPR titer≧ 1:4 and TPPA ≧1:320)

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* persons aged ≧20 year-old, who had documented syphilis infection (RPR titer≧ 1:4 and TPPA ≧1:320)

Exclusion Criteria:

* Nil

Primary outcomes:
measure: To compare serologic response of HIV-infected patients co-infected with early syphilis who received 1-dose or 3-doses benzathine penicillin G
timeFrame: 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:
measure: To compare the serologic response among HIV-infected and uninfected patients after receiving benzathine penicillin G
timeFrame: 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.
Other outcomes:
Locations:
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Far Eastern Memorial Hospital
Study officials:
affiliation: Far Eastern Memorial Hospital
name: Chia-Jui Yang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Taiwan University Hospital
name: Chien-Chin Hung, PHD
role: PRINCIPAL_INVESTIGATOR
References: