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

NCT ID: NCT02611765

Last Updated: 2016-05-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2012-04-30

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.

Detailed Description

The investigators conducted a prospective, randomized, open label study at three clinical sites including Thomas Street Health Center and North West Clinic (Harris Health System), and the Michael E. DeBakey Veterans Affairs Medical Center in Houston, Texas. After obtaining written informed consent, the investigators randomly assigned patients to either a single intramuscular injection of 2.4 million units of BPG (standard therapy) or three doses (enhanced therapy) of intramuscular BPG administered weekly (a total of 7.2 million units).

Patients were eligible for inclusion in the study if they were 18 years of age or older and had a diagnosis of HIV. The diagnosis of syphilis was made based on a positive Rapid Plasma Reagin (RPR) and treponema pallidum particle agglutination tests. Patients with primary, secondary and early latent syphilis were included.

Exclusion criteria were history of penicillin allergy, diagnosis of late latent syphilis, neurosyphilis, and antibiotic use with significant activity against Treponema pallidum within the preceding two weeks.

Follow-up period was 12 months. Serum samples were obtained at initial visit and follow-up visits every 3 months for serological testing for syphilis. Treatment success was defined as a decrease in RPR titer of >= 2 dilutions (4-fold) from the initial RPR titer during the follow-up period.

Both intention-to-treat and per-protocol analyses were performed

Conditions

Syphilis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Enhanced therapy

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)

Group Type: EXPERIMENTAL

Benzathine penicillin G intramuscular 7.2 million units

Intervention Type: DRUG

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

Standard therapy

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

Group Type: ACTIVE_COMPARATOR

Benzathine penicillin G intramuscular 2.4 million units

Intervention Type: DRUG

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

Interventions

Benzathine penicillin G intramuscular 7.2 million units

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

Intervention Type: DRUG

Benzathine penicillin G intramuscular 2.4 million units

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

Intervention Type: DRUG

Other Intervention Names

Enhanced therapy; Standard therapy

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baylor College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Jose Serpa-Alvarez

Co-Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jose A Serpa-Alvarez, MD

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor (Medicine: Infectious Disease)

References

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.

Reference Type: DERIVED

PMID: 28200045 (View on PubMed)

Other Identifiers

H-22816

Identifier Type: -

Identifier Source: org_study_id