Comparisons of Serologic Response of Early Syphilis

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.

Study Overview

• Status: Completed
• Conditions: Early Syphilis; Serologic Response of Syphilis; High Risk Behavior

• Study Type: Observational
• Enrollment (Actual): 1128

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 220
    • Far Eastern Memorial Hospital
  • Taipei City, Taiwan, 100
    • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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)

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Nil

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Taiwan AIDS study group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.

Secondary Outcome Measures

Outcome Measure	Time Frame
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.

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Collaborators: Chang Gung Memorial Hospital; Kaohsiung Medical University Chung-Ho Memorial Hospital; National Cheng-Kung University Hospital; Far Eastern Memorial Hospital; Taichung Veterans General Hospital; E-DA Hospital; Chi Mei Medical Hospital
• Investigators: Principal Investigator: Chia-Jui Yang, MD, Far Eastern Memorial Hospital; Principal Investigator: Chien-Chin Hung, PHD, National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2007
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: September 7, 2013
• First Submitted That Met QC Criteria: September 12, 2013
• First Posted (Estimate): September 17, 2013

Study Record Updates

• Last Update Posted (Estimate): September 17, 2013
• Last Update Submitted That Met QC Criteria: September 12, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Keywords: Syphilis; human immunodeficiency virus; penicillin
• Additional Relevant MeSH Terms: Infections; Communicable Diseases; Sexually Transmitted Diseases; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Sexually Transmitted Diseases, Bacterial; Spirochaetales Infections; Treponemal Infections; Syphilis
• Other Study ID Numbers: NTUH rec 201003111R