Comparisons of Serologic Response of Early Syphilis

NCT01944358 | Completed DMC

• 1 other identifier: NTUH rec 201003111R
• Study Type: observational
• Target: 1,128
• Locations: 1 country
• Sites: 2

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.

Conditions

Serologic Response of Syphilis; Early Syphilis; High Risk Behavior

Keywords

Syphilis; human immunodeficiency virus; penicillin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

Study Arms (1)

Taiwan AIDS study group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

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

You may not qualify if:

• Nil

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• Far Eastern Memorial Hospital: collaborator
• Taichung Veterans General Hospital: collaborator
• National Cheng-Kung University Hospital: collaborator
• Chang Gung Memorial Hospital: collaborator
• Chi Mei Medical Hospital: collaborator
• Kaohsiung Medical University Chung-Ho Memorial Hospital: collaborator
• E-DA Hospital: collaborator

Study Sites (2)

National Taiwan University Hospital

Taipei, Taiwan, 100, Taiwan

Location

Far Eastern Memorial Hospital

Taipei, Taiwan, 220, Taiwan

Location

MeSH Terms

Conditions

Syphilis; Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Treponemal Infections; Spirochaetales Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sexually Transmitted Diseases, Bacterial; Sexually Transmitted Diseases; Communicable Diseases; Genital Diseases; Urogenital Diseases; HIV Infections; Blood-Borne Infections; Sexually Transmitted Diseases, Viral; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Chia-Jui Yang, MD

  Far Eastern Memorial Hospital

  PRINCIPAL INVESTIGATOR

• Chien-Chin Hung, PHD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Taiwan HIV and Syphilis study group

Study Record Dates

• First Submitted: September 7, 2013
• First Posted: September 17, 2013
• Study Start: January 1, 2007
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2013
• Last Updated: September 17, 2013

Record last verified: 2013-09

Locations

TW (2)