Clinical Efficacy of Cefixime for the Treatment of Early Syphilis

Abstract Safe and efficacious alternative treatment options for syphilis are necessary. This randomized, 2-arm, noncomparative pilot study evaluated the efficacy of oral cefixime 400 mg in achieving a ≥4-fold rapid plasma reagin titer decrease by 3 or 6 months after treatment. The proportion of cefixime arm participants treated successfully was 87% (95% confidence interval, 69%–100%; 13/15). Clinical Trials Registration. NCT03752112.</jats:p

Clinical Trial Protocol to Evaluate the Efficacy of Cefixime in the Treatment of Early Syphilis

Abstract Background: Syphilis rates have been increasing both in the US and internationally with incidence higher among men-who-have-sex-with-men and people living with human immunodeficiency virus (HIV) infection. Currently, benzathine penicillin is the recommended treatment for syphilis in all patients. Global shortages and cost increases in benzathine penicillin call for alternative treatment options. This study evaluates the efficacy of oral cefixime for the treatment of early syphilis. Methods: We are conducting a randomized, multisite, open-label, non-comparative clinical trial in Los Angeles and Oakland, California. Eligible participants are ≥18 years old, with primary, secondary or early latent syphilis (Rapid Plasma Reagin [RPR] titer ≥1:8). Patients with HIV infection must have a viral load ≤200 copies/mL and CD4+ T cell count ≥350 cells/μl during the past 6 months. Participants are randomized to receive either 2.4M IU benzathine penicillin G intramuscularly once or cefixime 400mg orally twice a day for 10 days. Participants return at 3, 6, and 12 months post-treatment for follow-up RPR serological testing. The primary outcome is the proportion of participants who achieve ≥4-fold RPR titer decrease at 3- or 6-months post-treatment.Discussion: Clinical trials evaluating the efficacy of alternative antibiotics to penicillin are urgently needed. Trial Registration: Clinicaltrials.gov, NCT03660488. Registered September 4, 2018, https://clinicaltrials.gov/ct2/show/NCT03660488</jats:p

Clinical trial protocol to evaluate the efficacy of cefixime in the treatment of early syphilis

Abstract Background Syphilis rates have been increasing both in the USA and internationally with incidence higher among men-who-have-sex-with-men and people living with human immunodeficiency virus (HIV) infection. Currently, benzathine penicillin is the recommended treatment for syphilis in all patients. Global shortages and cost increases in benzathine penicillin call for alternative treatment options. This study evaluates the efficacy of oral cefixime for the treatment of early syphilis. Methods We are conducting a randomized, multisite, open-label, non-comparative clinical trial in Los Angeles and Oakland, CA. Eligible participants are ≥ 18 years old, with primary, secondary, or early latent syphilis (rapid plasma reagin [RPR] titer ≥ 1:8). Patients with HIV infection must have a viral load ≤ 200 copies/mL and CD4+ T cell count ≥ 350 cells/μL during the past 6 months. Participants are randomized to receive either 2.4 M IU benzathine penicillin G intramuscularly once or cefixime 400 mg orally twice a day for 10 days. Participants return at 3, 6, and 12 months post-treatment for follow-up RPR serological testing. The primary outcome is the proportion of participants who achieve ≥ 4-fold RPR titer decrease at 3 or 6 months post-treatment. Discussion Clinical trials evaluating the efficacy of alternative antibiotics to penicillin are urgently needed. Trial registration Clinicaltrials.gov NCT03660488. Registered on 4 September 2018. </jats:sec

Clinical Trial Protocol to Evaluate the Efficacy of Cefixime in the Treatment of Early Syphilis

Abstract Background: Syphilis rates have been increasing both in the US and internationally with incidence higher among men-who-have-sex-with-men and people living with human immunodeficiency virus (HIV) infection. Currently, benzathine penicillin is the recommended treatment for syphilis in all patients. Global shortages and cost increases in benzathine penicillin call for alternative treatment options. This study evaluates the efficacy of oral cefixime for the treatment of early syphilis. Methods: We are conducting a randomized, multisite, open-label, non-comparative clinical trial in Los Angeles and Oakland, California. Eligible participants are ≥18 years old, with primary, secondary or early latent syphilis (Rapid Plasma Reagin [RPR] titer ≥1:8). Patients with HIV infection must have a viral load ≤200 copies/mL and CD4+ T cell count ≥350 cells/μl during the past 6 months. Participants are randomized to receive either 2.4M IU benzathine penicillin G intramuscularly once or cefixime 400mg orally twice a day for 10 days. Participants return at 3, 6, and 12 months post-treatment for follow-up RPR serological testing. The primary outcome is the proportion of participants who achieve ≥4-fold RPR titer decrease at 3- or 6-months post-treatment.Discussion: Clinical trials evaluating the efficacy of alternative antibiotics to penicillin are urgently needed. Trial Registration: Clinicaltrials.gov, NCT03660488. Registered September 4, 2018, https://clinicaltrials.gov/ct2/show/NCT03660488</jats:p

Clinical Treatment Options Infectious Diseases: Update on PrEP Implementation, Adherence, and Advances in Delivery

Pre-exposure prophylaxis (PrEP) is an effective and evidence-based HIV-prevention option and is recommended for individuals with substantial risk for HIV infection [1]. Randomized controlled trials have demonstrated that daily oral PrEP dramatically reduces the risk of HIV infection when it is taken as directed. Concerns regarding widespread emergence of antiretroviral resistance attributable to PrEP and behavioral disinhibition have to date not been observed in clinical trials and open-label demonstration projects. PrEP has great potential as part of an HIV risk reduction strategy and barriers to wider implementation including community education, prescriber availability, and elimination of financial barriers should be aggressively pursued. Adherence is critical to PrEP efficacy and has varied across study populations; developing and refining ways of measuring and supporting adherence is essential to the success of PrEP. Evaluation of long-acting medications and alternative formulations for PrEP is underway and may lead to the wider implementation and impact of PrEP