Clinical Effectiveness and Safety of Amphotericin B With Flucytosine-Fluconazole Therapy for Cryptococcal Meningitis
NCT ID: NCT04532463
Last Updated: 2022-04-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
30 participants
OBSERVATIONAL
2020-10-01
2022-04-20
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Amphotericin B,Flucytosine, Fluconazole
Amphotericin B 1 mg/kg 1 week \& Flucytosine 100 mg/kg 1 week followed by Fluconazole 1200 mg/day 1 week
Amphotericin B 1 mg/kg 1 week & Flucytosine 100 mg/kg 1 week followed by Fluconazole 1200 mg/day 1 week
To study the clinical effectiveness and safety of amphotericin B with flucytosine-fluconazole therapy for cryptococcal meningitis in patients with HIV infection.
Interventions
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Amphotericin B 1 mg/kg 1 week & Flucytosine 100 mg/kg 1 week followed by Fluconazole 1200 mg/day 1 week
To study the clinical effectiveness and safety of amphotericin B with flucytosine-fluconazole therapy for cryptococcal meningitis in patients with HIV infection.
Eligibility Criteria
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Inclusion Criteria
2. Patients of both sexes
3. Age above 14 years
4. Patients or caregivers who will give informed consent to participate in this study
14 Years
ALL
No
Sponsors
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University of Pharmacy, Yangon
OTHER
Responsible Party
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Ms. Zin Win May, Principal Investigator
Clinical effectiveness and safety of Amphotericin B with Flucytosine-Fluconazole therapy for Cryptococcal meningitis in patients with HIV infection
Principal Investigators
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zin win may, B.Pharm
Role: PRINCIPAL_INVESTIGATOR
Specialist Hospital Thakeyta
Locations
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Specialist hospital Mingalardon,Thakeyta and Waibargi,Yangon General Hospital,Insein General Hospital, North Oakalapa General and Teaching Hosptial
Yangon, , Burma
Countries
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Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
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122020
Identifier Type: -
Identifier Source: org_study_id
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