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

NCT02611765 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2016-05-17

Study results available
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Summary

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.

Conditions

  • Syphilis

Interventions

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).

DRUG

Benzathine penicillin G intramuscular 2.4 million units

A single dose of intramuscular 2.4 million units of benzathine penicillin G

Sponsors & Collaborators

  • Baylor College of Medicine

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2012-04-30
Completion
2012-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02611765 on ClinicalTrials.gov