Syphilis Response to Higher Penicillin Dosage: The 2.4 Versus 7.2 Study

April 15, 2016 updated by: Jose Serpa-Alvarez, Baylor College of Medicine

Syphilis Response to Higher Penicillin Dosage in HIV Co-Infected Patients

Syphilis remains a significant health problem worldwide, with an estimated 10.6 million new cases per year. Due to shared transmission route and risk factors, co-infection with syphilis and Human Immunodeficiency Virus (HIV) is not uncommon. Several studies have evaluated the response to syphilis treatment in HIV-infected patients. They support the claim that patients with HIV have a slower decrease in syphilis antibody titers, and that they may progress to neurosyphilis in earlier stages.

The Center for Disease Control and Prevention's Sexually Transmitted Disease Treatment Guidelines has advocated treating HIV-infected patients who have primary, secondary syphilis or early latent syphilis with the same doses of penicillin as for HIV-uninfected patients (single dose of 2.4 million units of benzathine penicillin G). The investigators designed a randomized controlled trial in order to compare the efficacy of three- versus single-dosed regimens of intramuscular benzathine penicillin G (BPG) for the treatment of early syphilis in HIV-infected patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The investigators conducted a prospective, randomized, open label study at three clinical sites including Thomas Street Health Center and North West Clinic (Harris Health System), and the Michael E. DeBakey Veterans Affairs Medical Center in Houston, Texas. After obtaining written informed consent, the investigators randomly assigned patients to either a single intramuscular injection of 2.4 million units of BPG (standard therapy) or three doses (enhanced therapy) of intramuscular BPG administered weekly (a total of 7.2 million units).

Patients were eligible for inclusion in the study if they were 18 years of age or older and had a diagnosis of HIV. The diagnosis of syphilis was made based on a positive Rapid Plasma Reagin (RPR) and treponema pallidum particle agglutination tests. Patients with primary, secondary and early latent syphilis were included.

Exclusion criteria were history of penicillin allergy, diagnosis of late latent syphilis, neurosyphilis, and antibiotic use with significant activity against Treponema pallidum within the preceding two weeks.

Follow-up period was 12 months. Serum samples were obtained at initial visit and follow-up visits every 3 months for serological testing for syphilis. Treatment success was defined as a decrease in RPR titer of >= 2 dilutions (4-fold) from the initial RPR titer during the follow-up period.

Both intention-to-treat and per-protocol analyses were performed

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosed with HIV by ELISA and confirmed by Western blot
  • Positive Rapid Plasma Reagin and treponema pallidum particle agglutination tests

Exclusion Criteria:

  • History of penicillin allergy
  • Diagnosis of late latent syphilis
  • Diagnosis of neurosyphilis
  • Antibiotic use with significant activity against Treponema pallidum within the preceding two weeks

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Enhanced therapy
Benzathine penicillin G intramuscular 7.2 million units Three doses of 2.4 million units of intramuscular benzathine penicillin G administered weekly (a total of 7.2 million units)
Drug: Benzathine penicillin G intramuscular 7.2 million units
Three doses of intramuscular 2.4 million units of benzathine penicillin G administered weekly (a total of 7.2 million units).
Other Names:
  • Enhanced therapy
Active Comparator: Standard therapy
Benzathine penicillin G intramuscular 2.4 million units A single intramuscular injection of 2.4 million units of benzathine penicillin G
Drug: Benzathine penicillin G intramuscular 2.4 million units
A single dose of intramuscular 2.4 million units of benzathine penicillin G
Other Names:
  • Standard therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment Success Defined as a Decrease in Rapid Plasma Reagin (RPR) Titer of >= 2 Dilutions (4-fold)
Time Frame: 12 months
Number of participants who achieve treatment success. Loss to follow-up was assumed to be a failure.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baylor College of Medicine

Investigators

  • Principal Investigator: Jose A Serpa-Alvarez, MD, Assistant Professor (Medicine: Infectious Disease)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

November 19, 2015

First Submitted That Met QC Criteria

November 20, 2015

First Posted (Estimate)

November 23, 2015

Study Record Updates

Last Update Posted (Estimate)

May 17, 2016

Last Update Submitted That Met QC Criteria

April 15, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-22816

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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