scholarly journals Short-course High-dose Liposomal Amphotericin B for Human Immunodeficiency Virus–associated Cryptococcal Meningitis: A Phase 2 Randomized Controlled Trial

2018 ◽  
Vol 68 (3) ◽  
pp. 393-401 ◽  
Author(s):  
Joseph N Jarvis ◽  
Tshepo B Leeme ◽  
Mooketsi Molefi ◽  
Awilly A Chofle ◽  
Gabriella Bidwell ◽  
...  
Keyword(s):  
Human Immunodeficiency Virus ◽  
Randomized Controlled Trial ◽  
Cryptococcal Meningitis ◽  
Liposomal Amphotericin ◽  
Controlled Trial ◽  
High Dose ◽  
Phase 2 ◽  
Randomized Controlled ◽  
Short Course ◽  
Immunodeficiency Virus

scholarly journals A phase II randomized controlled trial adding oral flucytosine to high-dose fluconazole, with short-course amphotericin B, for cryptococcal meningitis

AIDS ◽  
2012 ◽  
Vol 26 (11) ◽  
pp. 1363-1370 ◽  
Author(s):  
Arthur T. Jackson ◽  
Jesse C. Nussbaum ◽  
Jacob Phulusa ◽  
Dan Namarika ◽  
Maria Chikasema ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Amphotericin B ◽  
Phase Ii ◽  
Cryptococcal Meningitis ◽  
Controlled Trial ◽  
High Dose ◽  
Randomized Controlled ◽  
Short Course

scholarly journals An open label randomized controlled trial of tamoxifen combined with amphotericin B and fluconazole for cryptococcal meningitis

eLife ◽  
2021 ◽  
Vol 10 ◽  
Author(s):  
Nguyen Thi Thuy Ngan ◽  
Nhat Thanh Hoang Le ◽  
Nguyen Ngo Vi Vi ◽  
Ninh Thi Thanh Van ◽  
Nguyen Thi Hoang Mai ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Cryptococcal Meningitis ◽  
Standard Care ◽  
Therapeutic Potential ◽  
Controlled Trial ◽  
High Dose ◽  
Open Label ◽  
Randomized Controlled ◽  
Cancer Agent

Background: Cryptococcal meningitis has high mortality. Flucytosine is a key treatment but is expensive and rarely available. The anti-cancer agent tamoxifen has synergistic anti-cryptococcal activity with amphotericin in vitro. It is off-patent, cheap, and widely available. We performed a trial to determine its therapeutic potential.Methods:Open label randomized controlled trial. Participants received standard care - amphotericin combined with fluconazole for the first two weeks - or standard care plus tamoxifen 300mg/day. The primary end point was Early Fungicidal Activity (EFA) - the rate of yeast clearance from cerebrospinal fluid (CSF). Trial registration https://clinicaltrials.gov/ct2/show/NCT03112031 .Results: 50 patients were enrolled, (median age 34 years, 35 male). Tamoxifen had no effect on EFA (- 0.48log10 colony-forming units/mL/CSF control arm versus -0.49 tamoxifen arm, difference - 0.005log10CFU/ml/day, 95%CI: -0.16, 0.15, P=0.95). Tamoxifen caused QTc prolongation.Conclusion: High dose tamoxifen does not increase the clearance rate of Cryptococcus from CSF. Novel, affordable therapies are needed.Funding:The trial was funded through the Wellcome Trust Asia Programme Vietnam Core Grant 106680 and a Wellcome Trust Intermediate Fellowship to JND grant number WT097147MA.

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