Clinical Effectiveness and Safety of Amphotericin B With Flucytosine-Fluconazole Therapy for Cryptococcal Meningitis

University of Pharmacy, Yangon

Status: Completed

Conditions: Cryptococcal Meningitis

Treatments: Drug: Amphotericin B 1 mg/kg 1 week & Flucytosine 100 mg/kg 1 week followed by Fluconazole 1200 mg/day 1 week

Study type: Observational

Funder types: Other

Identifiers

NCT04532463

122020

Details and patient eligibility

About

To study the clinical effectiveness and safety of amphotericin B with flucytosine-fluconazole therapy for cryptococcal meningitis in patients with HIV infection.

Full description

Cryptococcal meningitis is an AIDS-defining illness mostly caused by the fungus, Cryptococcus neoformans. In high-income countries, the use of amphotericin B in combination with a more expensive drug, flucytosine, is most effective for the management of cryptococcal meningitis; but access to flucytosine is severely limited in middle and low-income countries. In Myanmar, currently recommended regimen for cryptococcal meningitis are combination of amphotericin B with fluconazole. Although amphotericin plus flucytosine followed by fluconazole therapy is the currently preferred regimen in WHO treatment guidelines, it is not still commonly used in Myanmar clinical practice because of its limited availability. Therefore, the data regarding tolerability and clinical effectiveness of flucytosine are unavailable for Myanmar patients.

Although trials were carried out for investigating the effectiveness of flucytosine in the HIV population of Africa, the variability in drug response can occur in Myanmar patients due to the racial and genetic differences and whether it is effective and safe for Myanmar people is a great curiosity question for clinicians and healthcare workers. In Myanmar, amphotericin plus flucytosine followed by fluconazole regimen will be supplied by National AIDS Program (NAP) and indicated in 2020. Thus, the documents for effectiveness and safety profile need to be established. This is the reason that the effectiveness and safety of amphotericin B with flucytosine and fluconazole combination therapy should be studied. From this study, it can provide information to physicians regarding the effectiveness as well as safety of those drugs in the management of cryptococcal meningitis in HIV patients.

Enrollment: 30 patients

Sex: All

Ages: 14+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

1. Patients with HIV-associated cryptococcal meningitis, admitted to inpatient department of SHW, SHM, SHT, YGH, NOGTH and IGH during the study period
2. Patients of both sexes
3. Age above 14 years
4. Patients or caregivers who will give informed consent to participate in this study

Trial design

30 participants in 1 patient group

Amphotericin B,Flucytosine, Fluconazole

Description:

Amphotericin B 1 mg/kg 1 week \& Flucytosine 100 mg/kg 1 week followed by Fluconazole 1200 mg/day 1 week

Treatment:

Drug: Amphotericin B 1 mg/kg 1 week & Flucytosine 100 mg/kg 1 week followed by Fluconazole 1200 mg/day 1 week