dc.contributor.author | Jarvis, J.N. | |
dc.contributor.author | Lawrence, D.S. | |
dc.contributor.author | Meya, D.B. | |
dc.contributor.author | Kagimu, E. | |
dc.contributor.author | Kasibante, J. | |
dc.contributor.author | Mpoza, E. | |
dc.contributor.author | Rutakingirwa, M.K. | |
dc.contributor.author | Ssebambulidde, K. | |
dc.contributor.author | Tugume, L. | |
dc.contributor.author | Rhein, J. | |
dc.contributor.author | Boulware, D.R. | |
dc.contributor.author | Mwandumba, H.C. | |
dc.contributor.author | Moyo, M. | |
dc.contributor.author | Mzinganjira, H. | |
dc.contributor.author | Kanyama, C. | |
dc.contributor.author | Hosseinipour, M.C. | |
dc.contributor.author | Chawinga, C. | |
dc.contributor.author | Meintjes, G. | |
dc.contributor.author | Schutz, C. | |
dc.contributor.author | Comins, K. | |
dc.contributor.author | Singh, A. | |
dc.contributor.author | Muzoora, Conrad | |
dc.contributor.author | Jjunju, S. | |
dc.contributor.author | Nuwagira, Edwin | |
dc.contributor.author | Mosepele, M. | |
dc.contributor.author | Leeme, T. | |
dc.contributor.author | Siamisang, K. | |
dc.contributor.author | Ndhlovu, C.E. | |
dc.contributor.author | Hlupeni, A. | |
dc.contributor.author | Mutata, C. | |
dc.contributor.author | Widenfelt, E. van | |
dc.contributor.author | Chen, T. | |
dc.contributor.author | Wang, D. | |
dc.contributor.author | Hope, W. | |
dc.contributor.author | Chammard, T. Boyer‑ | |
dc.contributor.author | Loyse, A. | |
dc.contributor.author | Molloy, S.F. | |
dc.contributor.author | Youssouf, N. | |
dc.contributor.author | Lortholary, O. | |
dc.contributor.author | Lalloo, D.G. | |
dc.contributor.author | Jaffar, S. | |
dc.contributor.author | Harrison, T.S. | |
dc.date.accessioned | 2022-05-20T06:08:07Z | |
dc.date.available | 2022-05-20T06:08:07Z | |
dc.date.issued | 2022-03-24 | |
dc.identifier.citation | Jarvis, J. N., Lawrence, D. S., Meya, D. B., Kagimu, E., Kasibante, J., Mpoza, E., ... & Harrison, T. S. (2022). Single-Dose Liposomal Amphotericin B Treatment for Cryptococcal Meningitis. New England Journal of Medicine, 386(12), 1109-1120. | en_US |
dc.identifier.uri | http://ir.must.ac.ug/xmlui/handle/123456789/1988 | |
dc.description.abstract | Background: Cryptococcal meningitis is a leading cause of human immunodeficiency virus (HIV)–related death in sub-Saharan Africa. Whether a treatment regimen that includes a single high dose of liposomal amphotericin B would be efficacious is not known.
Methods: In this phase 3 randomized, controlled, noninferiority trial conducted in five African countries, we assigned HIV-positive adults with cryptococcal meningitis in a 1:1 ratio to receive either a single high dose of liposomal amphotericin B (10 mg per kilogram of body weight) on day 1 plus 14 days of flucytosine (100 mg per kilogram per day) and fluconazole (1200 mg per day) or the current World Health Organization–recommended treatment, which includes amphotericin B deoxycholate (1 mg per kilogram per day) plus flucytosine (100 mg per kilogram per day) for 7 days, followed by fluconazole (1200 mg per day) for 7 days (control). The primary end point was death from any cause at 10 weeks; the trial was powered to show noninferiority at a 10-percentage-point margin.
Results: A total of 844 participants underwent randomization; 814 were included in the intention-to-treat population. At 10 weeks, deaths were reported in 101 participants (24.8%; 95% confidence interval [CI], 20.7 to 29.3) in the liposomal amphotericin B group and 117 (28.7%; 95% CI, 24.4 to 33.4) in the control group (difference, −3.9 percentage points); the upper boundary of the one-sided 95% confidence interval was 1.2 percentage points (within the non-inferiority margin; P<0.001 for noninferiority). Fungal clearance from cerebrospinal fluid was −0.40 log10 colonyforming units (CFU) per milliliter per day in the liposomal amphotericin B group and −0.42 log10 CFU per milliliter per day in the control group. Fewer participants had grade 3 or 4 adverse events in the liposomal amphotericin B group than in The control group (50.0% vs. 62.3%).
Conclusions: Single-dose liposomal amphotericin B combined with flucytosine and fluconazole was noninferior to the WHO-recommended treatment for HIV-associated cryptococcal meningitis and was associated with fewer adverse events. (Funded by the European and Developing Countries Clinical Trials Partnership and others; Ambition ISRCTN number, ISRCTN72509687.) | en_US |
dc.language.iso | en_US | en_US |
dc.publisher | New England Journal of Medicine | en_US |
dc.subject | Liposomal Amphotericin B Treatment | en_US |
dc.subject | Single-Dose | en_US |
dc.subject | Cryptococcal Meningitis | en_US |
dc.subject | HIV– related death | en_US |
dc.subject | Africa | en_US |
dc.title | Single-Dose Liposomal Amphotericin B Treatment for Cryptococcal Meningitis | en_US |