Phase 4 Comparative Trial of Benzathine Penicillin G for Treatment of Early Syphilis in Subjects With or Without HIV Infection
Condition: Syphilis
MeSH terms: HIV Infections; Syphilis
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a phase 4, randomized, open-label, multicenter trial to evaluate the efficacy of a
      single injected dose of Benzathine Penicillin G (BPG) 2.4 MU (Arm 1) compared to three
      successive weekly injected doses of BPG 2.4 MU (Arm 2) for treatment of early syphilis in
      human immunodeficiency virus (HIV)-infected and HIV-uninfected subjects. The study will
      enroll 560 adults (to achieve 420 evaluable subjects) aged 18 years or older with untreated
      early syphilis (primary, secondary, or early latent). It will be conducted at 9 sites in the
      US and last for 48 months with patient participation duration of 12 months. The primary
      objective is to compare the serological response to therapy in subjects with early (primary,
      secondary, or early latent) syphilis treated with Benzathine Penicillin G (BPG) 2.4 million
      units (MU) once or weekly for three successive weeks.
    

Detailed description: 
      This is a phase 4, randomized, open-label, multicenter trial to evaluate the efficacy of a
      single injected dose of Benzathine Penicillin G (BPG) 2.4 MU (Arm 1) compared to three
      successive weekly injected doses of BPG 2.4 MU (Arm 2) for treatment of early syphilis in
      human immunodeficiency virus (HIV)-infected and HIV-uninfected subjects. The study will
      enroll 560 adults (to achieve 420 evaluable subjects) aged 18 years or older with untreated
      early syphilis (primary, secondary, or early latent). It will be conducted at 9 sites in the
      US and last for 48 months with patient participation duration of 12 months. The primary
      objective is to compare the serological response to therapy in subjects with early (primary,
      secondary, or early latent) syphilis treated with Benzathine Penicillin G (BPG) 2.4 million
      units (MU) once or weekly for three successive weeks. The secondary objectives are: 1) to
      determine if the difference in response to therapy between treatment arms by Month 6 differs
      among subjects with or without HIV infection; 2) to determine the impact of multiple BPG
      injected doses on subject compliance with study product and adherence to the corresponding
      scheduled visits; 3) to determine the incidence and manifestations of the Jarisch-Herxheimer
      reaction among subjects treated for early syphilis with BPG; 4) to collect prospective data
      up to Month 12 on the serological response to therapy in subjects treated for early syphilis
      with either BPG regimen; 5) to compare epidemiological characteristics of early syphilis
      among subjects with or without HIV infection.
    

Intervention name(s): Benzathine Penicillin
Intervention type(s): Drug
Intervention description(s): BPG will be administered as a deep intramuscular injection in the upper, outer quadrant of the buttock.
Intervention MeSH terms: Penicillins; Penicillin G Benzathine; Penicillin G; Penicillin G Procaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Benzathine penicillin G; Early Syphillis; HIV; Phase 4