Comparisons of Serologic Response of Early Syphilis

This study has been completed.
Sponsor:
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
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01944358
First received: September 7, 2013
Last updated: September 12, 2013
Last verified: September 2013
  Purpose

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.


Condition
Serologic Response of Syphilis
Early Syphilis
High Risk Behavior

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparisons of Treatment Response to Standard Treatment With Penicillin Between HIV-infected and HIV-uninfected Patients With Syphilis

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Enrollment: 1128
Study Start Date: January 2007
Study Completion Date: June 2013
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Taiwan AIDS study group

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Nil
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01944358

Locations
Taiwan
Far Eastern Memorial Hospital
Taipei, Taiwan, 220
National Taiwan University Hospital
Taipei City, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital
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
Investigators
Principal Investigator: Chia-Jui Yang, MD Far Eastern Memorial Hospital
Principal Investigator: Chien-Chin Hung, PHD National Taiwan University Hospital
  More Information

No publications provided

Responsible Party: National Taiwan University Hospital, Taiwan HIV and Syphilis study group
ClinicalTrials.gov Identifier: NCT01944358     History of Changes
Other Study ID Numbers: NTUH rec 201003111R
Study First Received: September 7, 2013
Last Updated: September 12, 2013
Health Authority: Taiwan: Institutional Review Board

Keywords provided by National Taiwan University Hospital:
Syphilis; human immunodeficiency virus; penicillin

Additional relevant MeSH terms:
Syphilis
Treponemal Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Sexually Transmitted Diseases, Bacterial
Spirochaetales Infections
Sexually Transmitted Diseases
Infection
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on August 21, 2014