CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 64 enrolled
Drug / intervention
Benzathine penicillin G intramuscular 7.2 million units +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02611765
NCT02611765Phase 4Completed

Syphilis Response to Higher Penicillin Dosage in HIV Co-Infected Patients

Baylor College of Medicine·interventional·Posted Nov 23, 2015·Updated May 17, 2016

In Brief

A Phase 4 clinical trial evaluating Benzathine penicillin G intramuscular 7.2 million units and Benzathine penicillin G intramuscular 2.4 million units for Syphilis. Completed, enrolled 64 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSyphilis
Countries--
Collaborators--

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 23, 2015
Enrollment StartSep 1, 2008
Primary CompletionApr 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 10.6 years ago

Interventions

Benzathine penicillin G intramuscular 7.2 million unitsdrug

Three doses of intramuscular 2.4 million units of benzathine penicillin G administered weekly (a total of 7.2 million units).

Benzathine penicillin G intramuscular 2.4 million unitsdrug

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