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NCT03637660 · ClinicalTrials.gov registry record · Phase 4
Phase 4 Comparative Trial of Benzathine Penicillin G for Treatment of Early Syphilis in Subjects With or Without HIV Infection
A Phase 4 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 4
- Development phase
- 249
- Enrollment target
NCT03637660 is a Phase 4 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 249 participants.
The verdict
NCT03637660, a Phase 4 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 249 participants
- Enrollment target
Study 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.
Interventions
- DRUG Benzathine Penicillin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 249 participants |
| Start Date | 2018-10-31 |
| Est. Completion | 2023-03-20 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03637660
The ClinicalTrials.gov registry entry for NCT03637660 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 249 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Benzathine Penicillin is the first listed.
NCT03637660 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03637660 about?
NCT03637660 is a clinical study titled "Phase 4 Comparative Trial of Benzathine Penicillin G for Treatment of Early Syphilis in Subjects With or Without HIV Infection". 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 (HI...
What is the current status of trial NCT03637660?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 249 participants. The study started on 2018-10-31. Estimated completion is 2023-03-20.
What interventions are being tested in trial NCT03637660?
The interventions under investigation include: Benzathine Penicillin (DRUG).
Who is sponsoring clinical trial NCT03637660?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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