Comparisons of Serologic Response of Early Syphilis

Early Syphilis Clinical Trial

Official title:

Comparisons of Treatment Response to Standard Treatment With Penicillin Between HIV-infected and HIV-uninfected Patients With Syphilis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01944358
• Other study ID #: NTUH rec 201003111R
• Status: Completed
• Phase: N/A
• First received: September 7, 2013
• Last updated: September 12, 2013
• Start date: January 2007
• Est. completion date: June 2013

Study information

• Verified date: September 2013
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1128
• Est. completion date: June 2013
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Early Syphilis
• High Risk Behavior
• Serologic Response of Syphilis
• Syphilis

Locations

Country	Name	City	State
Taiwan	Far Eastern Memorial Hospital	Taipei
Taiwan	National Taiwan University Hospital	Taipei City

Sponsors (8)

Lead Sponsor	Collaborator
National Taiwan University Hospital	Chang Gung Memorial Hospital, Chi Mei Medical Hospital, E-DA Hospital, Far Eastern Memorial Hospital, Kaohsiung Medical University Chung-Ho Memorial Hospital, National Cheng-Kung University Hospital, Taichung Veterans General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare serologic response of HIV-infected patients co-infected with early syphilis who received 1-dose or 3-doses benzathine penicillin G		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.	No
Secondary	To compare the serologic response among HIV-infected and uninfected patients after receiving benzathine penicillin G		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.	No