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

NCT02611765 | Completed Phase 4 Results

• 1 other identifier: H-22816
• Study Type: interventional
• Target: 64
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Syphilis

Outcome Measures

Primary Outcomes (1)

• Treatment Success Defined as a Decrease in Rapid Plasma Reagin (RPR) Titer of >= 2 Dilutions (4-fold)

  Number of participants who achieve treatment success. Loss to follow-up was assumed to be a failure.

  12 months

Study Arms (2)

Enhanced therapy

EXPERIMENTAL

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

Drug: Benzathine penicillin G intramuscular 7.2 million units

Standard therapy

ACTIVE COMPARATOR

Benzathine penicillin G intramuscular 2.4 million units A single intramuscular injection of 2.4 million units of benzathine penicillin G

Drug: Benzathine penicillin G intramuscular 2.4 million units

Interventions

Benzathine penicillin G intramuscular 7.2 million units DRUG

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

Also known as: Enhanced therapy

Enhanced therapy

Benzathine penicillin G intramuscular 2.4 million units DRUG

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

Also known as: Standard therapy

Standard therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with HIV by ELISA and confirmed by Western blot
• Positive Rapid Plasma Reagin and treponema pallidum particle agglutination tests

You may not qualify if:

• History of penicillin allergy
• Diagnosis of late latent syphilis
• Diagnosis of neurosyphilis
• Antibiotic use with significant activity against Treponema pallidum within the preceding two weeks

Sponsors & Collaborators

• Baylor College of Medicine: lead

Related Publications (1)

• Andrade R, Rodriguez-Barradas MC, Yasukawa K, Villarreal E, Ross M, Serpa JA. Single Dose Versus 3 Doses of Intramuscular Benzathine Penicillin for Early Syphilis in HIV: A Randomized Clinical Trial. Clin Infect Dis. 2017 Mar 15;64(6):759-764. doi: 10.1093/cid/ciw862.

  PMID: 28200045 DERIVED

MeSH Terms

Conditions

Syphilis

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Treponemal Infections; Spirochaetales Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sexually Transmitted Diseases, Bacterial; Sexually Transmitted Diseases; Communicable Diseases; Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Jose Serpa-Alvarez
• Organization: Baylor College of Medicine

jaserpaa@bcm.edu

713 798-7910

Study Officials

• Jose A Serpa-Alvarez, MD

  Assistant Professor (Medicine: Infectious Disease)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Investigator

Study Record Dates

• First Submitted: November 19, 2015
• First Posted: November 23, 2015
• Study Start: September 1, 2008
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: May 17, 2016
• Results First Posted: April 11, 2016

Record last verified: 2016-04