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Article: Baseline Cytomegalovirus Viremia at Cryptococcal Meningitis Diagnosis Is Associated With Long-term Increased Incident TB Disease and Mortality in a Prospective Cohort of Ugandan Adults With HIV.

Ellis, Jayne / Bangdiwala, Ananta S / Skipper, Caleb P / Tugume, Lillian / Nsangi, Laura / Matovu, John / Pastick, Katelyn A / Ssebambulidde, Kenneth / Morawski, Bozena M / Musubire, Abdu K / Schleiss, Mark R / Moore, David A J / Jarvis, Joseph N / Boulware, David R / Meya, David B / Castelnuovo, Barbara

Open forum infectious diseases

2023 Volume 10, Issue 9, Page(s) ofad449

Abstract: Background: Adults with HIV-associated cryptococcal meningitis have overlapping burdens of cytomegalovirus (CMV) and tuberculosis (TB) coinfections. CMV infection/reactivation is strongly associated with CMV-specific memory T-cell activation and ... ...

Abstract	Background: Adults with HIV-associated cryptococcal meningitis have overlapping burdens of cytomegalovirus (CMV) and tuberculosis (TB) coinfections. CMV infection/reactivation is strongly associated with CMV-specific memory T-cell activation and upregulation of type 1 interferons, which may lead to increased risk of TB disease and poor outcomes. Methods: We conducted a cohort study of 2-week survivors of cryptococcal meningitis during 2010-2021 to determine TB incidence and all-cause mortality over time stratified by baseline CMV status. Results: We followed 497 Ugandans with HIV-associated cryptococcal meningitis for a median (interquartile range) of 4.6 (2.6-53.9) months. Overall, 42% (210/497) developed incident TB disease or died. One-fifth (98/497, 19.7%) developed incident TB disease, and 29% (142/497) of participants died during follow-up. Of 259 participants with CMV viral load measured at baseline, 37% (96/259) had concurrent CMV viremia (defined as anyone with detectable CMV DNA in plasma/serum by qualitative polymerase chain reaction [PCR] detection). Of 59 with measured CMV immunoglobulin G (IgG), 100% had positive CMV IgG antibody serology (≥10 enzyme-linked immunosorbent assay units/mL). CMV viremia was positively associated with higher HIV viral load (196 667 vs 73 295 copies/mL; Conclusions: CMV viremia >1000 IU/mL at meningitis diagnosis was associated with increased incident TB disease and mortality during long-term follow-up. Future studies to determine the causal relationship and potential for therapeutic intervention are warranted.
Language	English
Publishing date	2023-09-19
Publishing country	United States
Document type	Journal Article
ZDB-ID	2757767-3
ISSN	2328-8957
ISSN	2328-8957
DOI	10.1093/ofid/ofad449
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Article: Therapeutic Lumbar Punctures in Human Immunodeficiency Virus-Associated Cryptococcal Meningitis: Should Opening Pressure Direct Management?

Kagimu, Enock / Engen, Nicole / Ssebambulidde, Kenneth / Kasibante, John / Kiiza, Tadeo K / Mpoza, Edward / Tugume, Lillian / Nuwagira, Edwin / Nsangi, Laura / Williams, Darlisha A / Hullsiek, Kathy Huppler / Boulware, David R / Meya, David B / Rhein, Joshua / Abassi, Mahsa / Musubire, Abdu K

Open forum infectious diseases

2022 Volume 9, Issue 9, Page(s) ofac416

Abstract: Background: Increased intracranial pressure (ICP) frequently complicates cryptococcal meningitis. Therapeutic lumbar punctures (LPs) have acute survival benefits in the first week, and we sought to understand the longer-term survival impact of ... ...

Abstract	Background: Increased intracranial pressure (ICP) frequently complicates cryptococcal meningitis. Therapeutic lumbar punctures (LPs) have acute survival benefits in the first week, and we sought to understand the longer-term survival impact of therapeutic LPs. Methods: We prospectively enrolled human immunodeficiency virus (HIV)-seropositive adults with cryptococcal meningitis from 2013 to 2017 in Uganda. We assessed the association between clinical characteristics, CSF parameters, and 14- and 30-day mortality by baseline ICP. We also assessed 30-day mortality by number of follow-up therapeutic LPs performed within 7 days. Results: Our analysis included 533 participants. Participants with baseline ICP >350 mm H Conclusions: Management of increased ICP remains crucial in improving clinical outcomes in cryptococcal meningitis. Guidelines should consider an approach to therapeutic LPs that is not dictated by baseline ICP.
Language	English
Publishing date	2022-08-17
Publishing country	United States
Document type	Journal Article
ZDB-ID	2757767-3
ISSN	2328-8957
ISSN	2328-8957
DOI	10.1093/ofid/ofac416
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Article: Association of Hyponatremia on Mortality in Cryptococcal Meningitis: A Prospective Cohort.

Tugume, Lillian / Fieberg, Ann / Ssebambulidde, Kenneth / Nuwagira, Edwin / Williams, Darlisha A / Mpoza, Edward / Rutakingirwa, Morris K / Kagimu, Enoch / Kasibante, John / Nsangi, Laura / Jjunju, Samuel / Musubire, Abdu K / Muzoora, Conrad / Lawrence, David S / Rhein, Joshua / Meya, David B / Hullsiek, Kathy Huppler / Boulware, David R / Abassi, Mahsa

Open forum infectious diseases

2022 Volume 9, Issue 7, Page(s) ofac301

Abstract: Background: Sodium abnormalities are frequent in central nervous system infections and may be caused by cerebral salt wasting, syndrome of inappropriate antidiuretic hormone secretion, or medication adverse events. In cryptococcal meningitis (CM), the ... ...

Abstract	Background: Sodium abnormalities are frequent in central nervous system infections and may be caused by cerebral salt wasting, syndrome of inappropriate antidiuretic hormone secretion, or medication adverse events. In cryptococcal meningitis (CM), the prevalence of baseline hyponatremia and whether hyponatremia adversely impacts survival is unknown. Methods: We conducted a secondary analysis of data from 2 randomized trials of human immunodeficiency virus-infected adult Ugandans with CM. We grouped serum sodium into 3 categories: <125, 125-129, and 130-145 mmol/L. We assessed whether baseline sodium abnormalities were associated with clinical characteristics and survival. Results: Of 816 participants with CM, 741 (91%) had a baseline sodium measurement available: 121 (16%) had grade 3-4 hyponatremia (<125 mmol/L), 194 (26%) had grade 2 hyponatremia (125-129 mmol/L), and 426 (57%) had a baseline sodium of 130-145 mmol/L. Hyponatremia (<125 mmol/L) was associated with higher initial cerebrospinal fluid (CSF) quantitative culture burden ( Conclusions: Hyponatremia is common in CM and is associated with excess mortality. A standardized management approach to correctly diagnose and correct hyponatremia in CM needs to be developed and tested.
Language	English
Publishing date	2022-06-17
Publishing country	United States
Document type	Journal Article
ZDB-ID	2757767-3
ISSN	2328-8957
ISSN	2328-8957
DOI	10.1093/ofid/ofac301
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Article: Utility of Cerebrospinal Fluid Protein Levels as a Potential Predictive Biomarker of Disease Severity in HIV-Associated Cryptococcal Meningitis.

medRxiv : the preprint server for health sciences

2023

Abstract: Background: Cerebrospinal fluid (CSF) protein levels exhibit high variability in HIV-associated cryptococcal meningitis from being normal to markedly elevated. However, the clinical implications of CSF protein levels in cryptococcal meningitis remain ... ...

Abstract	Background: Cerebrospinal fluid (CSF) protein levels exhibit high variability in HIV-associated cryptococcal meningitis from being normal to markedly elevated. However, the clinical implications of CSF protein levels in cryptococcal meningitis remain unclear. Methods: We analysed data from 890 adults with HIV-associated cryptococcal meningitis randomized into two clinical trials in Uganda between 2015 and 2021. CSF protein was grouped into ≥100 mg/dL (n=249) and <100 mg/dL (n=641). We described baseline clinical variables and mortality by CSF protein levels. Results: Approximately one-third of individuals had a baseline CSF protein ≥100 mg/dL. Those with CSF protein ≥100 mg/dL were more likely to present with Glasgow coma scale scores <15 (P<0.01), self-reported seizures at baseline (P=0.02), higher CD4 T-cells (p<0.001), and higher CSF white cells (p<0.001). Moreover, those with a baseline CSF protein ≥100 mg/dL also had a lower baseline CSF fungal burden (p<0.001) and a higher percentage of sterile CSF cultures at day 14 (p=0.02). Individuals with CSF protein ≥100 mg/dL demonstrated a more pronounced immune response consisting of upregulation of immune effector molecules pro-inflammatory cytokines, type-1 T-helper cell cytokines, type-3 chemokines, and immune-exhaustion marker (p<0.05). 18-week mortality risk in individuals with a CSF protein <100 mg/dL was 34% higher, (unadjusted Hazard Ratio 1.34; 95% CI, 1.05 to 1.70; p=0.02) than those with ≥100 mg/dL. Conclusion: In cryptococcal meningitis, individuals with CSF protein ≥100 mg/dL more frequently presented with seizures, altered mental status, immune activation, and favourable fungal outcomes. Baseline CSF protein levels may serve as a surrogate marker of immune activation and prognosis.
Language	English
Publishing date	2023-12-11
Publishing country	United States
Document type	Preprint
DOI	10.1101/2023.12.10.23299793
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Article ; Online: Implementation of accelerated research: strategies for implementation as applied in a phase 1 Ad26.ZEBOV, MVA-BN-Filo two-dose Ebola vaccine clinical trial in Uganda.

Kitonsa, Jonathan / Ggayi, Abu-Baker / Anywaine, Zacchaeus / Kisaakye, Eva / Nsangi, Laura / Basajja, Vincent / Nyantaro, Mary / Watson-Jones, Deborah / Shukarev, Georgi / Ilsbroux, Ine / Robinson, Cynthia / Kaleebu, Pontiano

Global health action

2020 Volume 13, Issue 1, Page(s) 1829829

Abstract: Background: The 2013-2016 Ebola epidemic in West Africa is the worst ever caused by : Objective: We report on the strategies utilised by the Unit and sponsor in ensuring expedited clinical trial approval and accelerated conduct.: Methods: Janssen ... ...

Abstract	Background: The 2013-2016 Ebola epidemic in West Africa is the worst ever caused by Objective: We report on the strategies utilised by the Unit and sponsor in ensuring expedited clinical trial approval and accelerated conduct. Methods: Janssen Vaccines and Prevention B.V. conducted a phase 1 trial to evaluate the safety, tolerability, and immunogenicity of heterologous two-dose vaccination regimens using Ad26.ZEBOV and MVA-BN-Filo, in healthy adults in Africa. Accelerated implementation strategies are hereby presented. Results: Strategies included: holding the African Vaccine Regulatory Forum (AVAREF) joint review meeting; expedited review by institutional ethics and country-specific regulatory bodies; competitive recruitment between sites; electronic data capture (EDC); frequent study monitoring schedule; involvement of a community advisory board (CAB); and utilization of a 'phased' study information-sharing approach in community engagement and participant recruitment. These strategies enabled the site to acquire approvals within 2 months and enrol 47 participants within a spurn of five. The same milestone is usually acquired in at least 1 year without accelerated implementation. Conclusion: The use of well-thought strategies by sponsors and research sites can enable the implementation of accelerated research. We recommend the use of similar strategies in other settings.
MeSH term(s)	Adolescent ; Adult ; Africa, Western ; Ebola Vaccines/administration & dosage ; Ebola Vaccines/immunology ; Ebolavirus ; Epidemics ; Female ; Hemorrhagic Fever, Ebola/epidemiology ; Hemorrhagic Fever, Ebola/prevention & control ; Humans ; Male ; Middle Aged ; Research Design ; Single-Blind Method ; Uganda ; Young Adult
Chemical Substances	Ebola Vaccines
Language	English
Publishing date	2020-12-01
Publishing country	United States
Document type	Clinical Trial, Phase I ; Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	2540569-X
ISSN	1654-9880 ; 1654-9880
ISSN (online)	1654-9880
ISSN	1654-9880
DOI	10.1080/16549716.2020.1829829
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Article ; Online: Oral Lipid Nanocrystal Amphotericin B for Cryptococcal Meningitis: A Randomized Clinical Trial.

Boulware, David R / Atukunda, Mucunguzi / Kagimu, Enock / Musubire, Abdu K / Akampurira, Andrew / Tugume, Lillian / Ssebambulidde, Kenneth / Kasibante, John / Nsangi, Laura / Mugabi, Timothy / Gakuru, Jane / Kimuda, Sarah / Kasozi, Derrick / Namombwe, Suzan / Turyasingura, Isaac / Rutakingirwa, Morris K / Mpoza, Edward / Kigozi, Enos / Muzoora, Conrad /

Ellis, Jayne / Skipper, Caleb P / Matkovits, Theresa / Williamson, Peter R / Williams, Darlisha A / Fieberg, Ann / Hullsiek, Kathy H / Abassi, Mahsa / Dai, Biyue / Meya, David B

Clinical infectious diseases : an official publication of the Infectious Diseases Society of America

2023 Volume 77, Issue 12, Page(s) 1659–1667

Abstract: Background: Amphotericin B is the gold standard treatment for severe mycoses. A new orally delivered, less-toxic formulation of amphotericin has been developed.: Methods: In our randomized clinical trial, we tested oral lipid nanocrystal (LNC) ... ...

Abstract	Background: Amphotericin B is the gold standard treatment for severe mycoses. A new orally delivered, less-toxic formulation of amphotericin has been developed. Methods: In our randomized clinical trial, we tested oral lipid nanocrystal (LNC) amphotericin B (MAT2203, Matinas Biopharma) vs intravenous (IV) amphotericin for human immunodeficiency virus-associated cryptococcal meningitis in 4 sequential cohorts. Two pilot cohorts assessed safety and tolerability (n = 10 each), and 2 cohorts assessed efficacy with/without 2 IV loading doses (n = 40 each). The experimental arm received 1.8 g/d oral LNC amphotericin through 2 weeks with 100 mg/kg/d flucytosine, then 1.2 g/d LNC amphotericin through 6 weeks. The randomized control arm (n = 41) received 7 days of IV amphotericin with flucytosine, then 7 days of fluconazole 1200 mg/d. The primary end point was cerebrospinal fluid (CSF) early fungicidal activity (EFA). Results: We randomized 80 participants to oral LNC amphotericin + flucytosine with (n = 40) and without (n = 40) 2 IV loading doses and 41 control participants to IV amphotericin + flucytosine. Mean EFA was 0.40 log10 colony-forming units (CFU)/mL/d for all-oral LNC amphotericin, 0.42 log10 Cryptococcus CFU/mL/d for oral LNC amphotericin with IV loading doses, and 0.46 log10 CFU/mL/d for IV amphotericin controls. LNC amphotericin groups achieved 2-week CSF sterility in 63% (44 of 70) vs 68% (23 of 34) of controls. The 18-week survival was 85% (34 of 40) with all-oral LNC amphotericin, 90% (36 of 40) with oral LNC amphotericin given IV loading doses, and 85% (35 of 41) with IV amphotericin.Grade 3-4 laboratory adverse events occurred less frequently in LNC amphotericin groups (41%) than the IV amphotericin group (61%, P = .05), particularly for anemia (21% vs 44%; P = .01) and potassium (5% vs 17%; P = .04). Conclusions: This new oral amphotericin B LNC formulation appears promising for cryptococcal meningitis with antifungal activity, similar survival, and less toxicity than IV amphotericin. Clinical trials registration: NCT04031833.
MeSH term(s)	Humans ; Meningitis, Cryptococcal/drug therapy ; Amphotericin B/adverse effects ; Flucytosine/adverse effects ; Drug Therapy, Combination ; Antifungal Agents/adverse effects ; Fluconazole/therapeutic use ; Vaccines ; Lipids
Chemical Substances	Amphotericin B (7XU7A7DROE) ; Flucytosine (D83282DT06) ; Antifungal Agents ; Fluconazole (8VZV102JFY) ; Vaccines ; Lipids
Language	English
Publishing date	2023-08-22
Publishing country	United States
Document type	Randomized Controlled Trial ; Journal Article ; Research Support, N.I.H., Intramural
ZDB-ID	1099781-7
ISSN	1537-6591 ; 1058-4838
ISSN (online)	1537-6591
ISSN	1058-4838
DOI	10.1093/cid/ciad440
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Article ; Online: A Journey of Hope: giving research participants a voice to share their experiences and improve community engagement around advanced HIV disease in Uganda.

AAS open research

2020 Volume 3, Page(s) 33

Abstract: Over the last decade excellent progress has been made globally in HIV management thanks to antiretroviral therapy (ART) rollout and international guidelines now recommending immediate initiation of ART in people living with HIV. Despite this, advanced ... ...

Abstract	Over the last decade excellent progress has been made globally in HIV management thanks to antiretroviral therapy (ART) rollout and international guidelines now recommending immediate initiation of ART in people living with HIV. Despite this, advanced HIV disease (CD4 less than 200 cells/mL) and opportunistic infections remain a persistent challenge and contribute significantly to HIV-associated mortality, which equates to 23,000 deaths in Uganda in 2018 alone. Our Meningitis Research Team based in Uganda is committed to conducting clinical trials to answer important questions regarding diagnostics and management of HIV-associated opportunistic infections, including tuberculosis and cryptococcal meningitis. However, clinical research is impossible without research participants and results are meaningless unless they are translated into benefits for those affected by the disease. Therefore, we held a series of community engagement events with the aims of 1) giving research participants a voice to share their experiences of clinical research and messages of hope around advanced HIV disease with the community, 2) dispelling myths and stigma around HIV, and 3) raising awareness about the complications of advanced HIV disease and local clinical research and recent scientific advances. The purpose of this Open Letter is to describe our community engagement experience in Uganda, where we aimed to give clinical research participants a greater voice to share their experiences. These activities build upon decades of work in HIV community engagement and lays a platform for future research and engagement activities.
Language	English
Publishing date	2020-10-29
Publishing country	England
Document type	Journal Article
ISSN	2515-9321
ISSN (online)	2515-9321
DOI	10.12688/aasopenres.13104.2
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Article: Baseline Cytomegalovirus Viremia at Cryptococcal Meningitis Diagnosis Is Associated With Long-term Increased Incident TB Disease and Mortality in a Prospective Cohort of Ugandan Adults With HIV.

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Article: Therapeutic Lumbar Punctures in Human Immunodeficiency Virus-Associated Cryptococcal Meningitis: Should Opening Pressure Direct Management?

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Article: Association of Hyponatremia on Mortality in Cryptococcal Meningitis: A Prospective Cohort.

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Article: Utility of Cerebrospinal Fluid Protein Levels as a Potential Predictive Biomarker of Disease Severity in HIV-Associated Cryptococcal Meningitis.

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Article ; Online: Implementation of accelerated research: strategies for implementation as applied in a phase 1 Ad26.ZEBOV, MVA-BN-Filo two-dose Ebola vaccine clinical trial in Uganda.

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Article ; Online: Oral Lipid Nanocrystal Amphotericin B for Cryptococcal Meningitis: A Randomized Clinical Trial.

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Article ; Online: A Journey of Hope: giving research participants a voice to share their experiences and improve community engagement around advanced HIV disease in Uganda.

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Inter-library loan at ZB MED