drugset / Trial / NCT02611765

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

NCT02611765

Phase 4 Completed 64 enrolled Baylor College of Medicine
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Benzathine Penicillin G Unknown 2.4e+06 iu Intramuscular

Indications