Phase 4 Comparative Trial of Benzathine Penicillin G for Treatment of Early Syphilis in Subjects With or Without HIV Infection
Public ClinicalTrials.gov record NCT03637660. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 4 Comparative Trial of Benzathine Penicillin G 2.4 Million Units Administered as a Single Dose Versus Three Successive Weekly Doses for Treatment of Early Syphilis in Subjects With or Without HIV Infection
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03637660
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 249 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 99 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 31, 2018 (Actual)
- Primary completion
- Sep 7, 2022 (Actual)
- Completion
- Mar 20, 2023 (Actual)
- Last update posted
- Jan 14, 2025
2018 – 2023
United States locations
- U.S. sites
- 10
- U.S. states
- 9
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham School of Medicine - Infectious Disease | Birmingham | Alabama | 35294 | — |
| Emory University Hospital Midtown - Emory Clinic Infectious Diseases | Atlanta | Georgia | 30308 | — |
| Indiana University School of Medicine - Infectious Diseases | Indianapolis | Indiana | 46202 | — |
| Louisiana State University Health Sciences Center | New Orleans | Louisiana | 70119 | — |
| Johns Hopkins Bayview Medical Center - Infectious Diseases | Baltimore | Maryland | 21224 | — |
| Fenway Health - The Fenway Institute | Boston | Massachusetts | 02115 | — |
| University of North Carolina School of Medicine - Center for Infectious Diseases | Durham | North Carolina | 27701-3720 | — |
| Wake Forest Baptist Health - Infectious Diseases | Winston-Salem | North Carolina | 27157 | — |
| Magee Women's Hospital of UPMC - Reproductive Infectious Disease Research | Pittsburgh | Pennsylvania | 15213 | — |
| University of Washington - Harborview Medical Center - Center for AIDS and STD | Seattle | Washington | 98104-2433 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03637660, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 14, 2025 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03637660 live on ClinicalTrials.gov.