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

September 7, 2013
September 12, 2013
January 2007
June 2012   (final data collection date for 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. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01944358 on ClinicalTrials.gov Archive Site
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 ]
Same as current
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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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

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

  • Serologic Response of Syphilis
  • Early Syphilis
  • High Risk Behavior
Not Provided
Taiwan AIDS study group
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1128
June 2013
June 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Nil
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
NCT01944358
NTUH rec 201003111R
Yes
National Taiwan University Hospital
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
Principal Investigator: Chia-Jui Yang, MD Far Eastern Memorial Hospital
Principal Investigator: Chien-Chin Hung, PHD National Taiwan University Hospital
National Taiwan University Hospital
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP