Page last updated: 2024-12-11

amphotericin b, deoxycholate drug combination

Description Research Excerpts Clinical Trials Roles Classes Pathways Study Profile Bioassays Related Drugs Related Conditions Protein Interactions Research Growth

Cross-References

ID SourceID
PubMed CID23668620
MeSH IDM0166171

Synonyms (11)

Synonym
desoxycholate amphotericin b
amphotericin b-deoxycholate
amphotericin b, mixt. with (3-alpha,5-beta,12-alpha)-3,12-dihydroxycholan-24-oic acid monosodium salt
amphotericin b deoxycholate
amphotericin b - deoxycholate
amphotericin b, deoxycholate drug combination
amphotericin b sodium desoxycholate mixt.
amb-doc
44wg8e9mtu ,
unii-44wg8e9mtu
amphotericin b deoxycholate [who-dd]

Research Excerpts

Toxicity

ExcerptReferenceRelevance
" Thus, ABCD shows promise as an effective but less toxic alternative to ABDS for the treatment of disseminated cryptococcosis."( Efficacy and safety of amphotericin B colloidal dispersion compared with those of amphotericin B deoxycholate suspension for treatment of disseminated murine cryptococcosis.
Clemons, KV; Hanson, LH; Hostetler, JS; Stevens, DA, 1992
)
0.28
"01) with the LD50 of AmB."( Influence of diet on experimental toxicity of amphotericin B deoxycholate.
Bolard, J; Carbon, C; Chavanet, P; Joly, V; Rigaud, D; Yeni, P, 1994
)
0.29
"Nephrotoxicity is an important side effect of amphothericin B deoxycholate (ampho B) and cyclosporine A (CsA)."( Nephrotoxicity of cyclosporine A and amphotericin B-deoxycholate as continuous infusion in allogenic stem cell transplantation.
Furrer, K; Halter, J; Imhof, A; Schaffner, A; Schanz, U; Vavricka, SR, 2002
)
0.31
" Expensive lipid formulations of amphotericin B (AmB) are generally used because of fear of adverse effects due to concomitant cyclosporine A and other nephrotoxic drugs."( Tolerability, safety and efficacy of conventional amphotericin B administered by 24-hour infusion to lung transplant recipients.
Boehler, A; Dutly, A; Naef, R; Russi, EW; Speich, R; Weder, W, 2002
)
0.31
"Based on histologic data, increasing doses of all three agents appear to be associated with increasing toxicity, however based on ophthalmologic data, L-AmB appears to be less toxic than either amphotericin B deoxycholate or ABLC."( Comparative toxicity and concentrations of intravitreal amphotericin B formulations in a rabbit model.
Cannon, JP; Danziger, LH; De Alba, F; Edward, DP; Fiscella, R; Garey, KW; Pattharachayakul, S; Piscitelli, S, 2003
)
0.32
" Treatment-related adverse events and invasive fungal infections were quantitated for 2 months after study drug initiation."( Comparative safety of amphotericin B lipid complex and amphotericin B deoxycholate as aerosolized antifungal prophylaxis in lung-transplant recipients.
Benjamin, DK; Dodds Ashley, E; Drew, RH; Duane Davis, R; Palmer, SM; Perfect, JR, 2004
)
0.32
" Patients receiving ABLC were less likely to experience a treatment-related adverse event."( Comparative safety of amphotericin B lipid complex and amphotericin B deoxycholate as aerosolized antifungal prophylaxis in lung-transplant recipients.
Benjamin, DK; Dodds Ashley, E; Drew, RH; Duane Davis, R; Palmer, SM; Perfect, JR, 2004
)
0.32
" We conclude that continuous infusion of amphotericin B is safe in neutropenic patients with hematological malignancies."( Brief report: practicability and safety of amphotericin B deoxycholate as continuous infusion in neutropenic patients with hematological malignancies.
Knöbl, P; Rabitsch, W; Schulenburg, A; Sperr, W; Thalhammer, F, 2005
)
0.33
"Amphotericin B deoxycholate (AmBd) has been a standard therapy for IFI but is associated with high adverse event and mortality rates."( Should we continue using amphotericin B deoxycholate for the treatment of fungal infections? Adverse events and clinical outcomes.
Garbino, J; Lew, D; Markham, L; Matulionyte, R; Rives, V, 2006
)
0.33
" However, d-AMB is a toxic drug, the most important dose-limiting toxicities being nephrotoxicity and infusion-related allergic reactions."( Amphotericin B deoxycholate (d-AMB) use in cases with febrile neutropenia and fungal infections: lower toxicity with suitable premedication.
Disel, U; Oto, OA; Paydas, S; Seydaoglu, G; Yavuz, S, 2007
)
0.34
"In lung transplant recipients, both inhaled AmBd and L-AmB were safe and well tolerated over a large number of medication exposures."( Safety of aerosolized liposomal versus deoxycholate amphotericin B formulations for prevention of invasive fungal infections following lung transplantation: a retrospective study.
Baden, LR; Deykin, A; Fiumara, K; Lee, JT; Lowry, CM; Marty, FM; Vargas, SO, 2007
)
0.34
" But the need for prolonged hospitalisation and frequent, occasionally serious, adverse events are its major drawbacks."( Safety of a pre-formulated amphotericin B lipid emulsion for the treatment of Indian Kala-azar.
Agarwal, D; Agrawal, N; Chakravarty, J; Rai, M; Shah, A; Sundar, S, 2008
)
0.35
"To evaluate medical indications of this compound in a tertiary care center, analyze adverse reactions, infusion protocols and outcome of treated patients."( [Amphotericin B deoxycholate prescription and adverse events in a Chilean university hospital].
Abusada A, N; Fica C, A; Gallardo A, C; Muñoz C, L; Novoa M, C; Quinteros A, R, 2010
)
0.36
"Retrospective analysis of 39 treatments indicated in 33 patients during 2007, exploring indications, infusion protocols and renal protective measures, infusion-related adverse reactions, nephrotoxicity, hypokalemia and outcomes."( [Amphotericin B deoxycholate prescription and adverse events in a Chilean university hospital].
Abusada A, N; Fica C, A; Gallardo A, C; Muñoz C, L; Novoa M, C; Quinteros A, R, 2010
)
0.36
" Adverse reactions were observed in 40% of treatments, predominating fever (25%)."( [Amphotericin B deoxycholate prescription and adverse events in a Chilean university hospital].
Abusada A, N; Fica C, A; Gallardo A, C; Muñoz C, L; Novoa M, C; Quinteros A, R, 2010
)
0.36
"infusion-related adverse reactions are frequent during amphotericin B deoxycholate therapy, but renal toxicity is occasionally observed."( [Amphotericin B deoxycholate prescription and adverse events in a Chilean university hospital].
Abusada A, N; Fica C, A; Gallardo A, C; Muñoz C, L; Novoa M, C; Quinteros A, R, 2010
)
0.36
" However, administration of this drug is accompanied by substantial adverse effects."( Comparison of 2 doses of liposomal amphotericin B and conventional amphotericin B deoxycholate for treatment of AIDS-associated acute cryptococcal meningitis: a randomized, double-blind clinical trial of efficacy and safety.
Barker, DE; El-Sadr, W; Graybill, JR; Hamill, RJ; Javaly, K; Johnson, PC; Sobel, JD, 2010
)
0.36
" Anemia remained a concerning adverse effect."( Toxicity of Amphotericin B Deoxycholate-Based Induction Therapy in Patients with HIV-Associated Cryptococcal Meningitis.
Bicanic, T; Bottomley, C; Brouwer, AE; Harrison, TS; Hosseinipour, MC; Jackson, A; Jarvis, JN; Limmathurotsakul, D; Loyse, A; Meintjes, G; Muzoora, C; Phulusa, J; Taseera, K; van der Horst, C; White, NJ; Wilson, D; Wood, R, 2015
)
0.42
" However, some untoward adverse effects such as nephrotoxicity may limit its appropriate therapeutic use."( Efficacy of Intralipid infusion in reducing amphotericin-B-associated nephrotoxicity in head and neck invasive fungal infection: A randomized, controlled trial.
Asadollahi, M; Hasibi, M; Jafari, S; Kouhi, A; Manshadi, SA; Salehi, M; Zarch, VV, 2017
)
0.46
" Few studies showing conflictive data about their efficacy and adverse events in pediatric population are available."( Efficacy and safety of amphotericin B deoxycholate versus N-methylglucamine antimoniate in pediatric visceral leishmaniasis: an open-label, randomized, and controlled pilot trial in Brazil.
Borges, MM; Carranza-Tamayo, CO; Noronha, EF; Pranchevicius, MC; Romero, GA,
)
0.13
" All patients reported adverse events (AE)."( Efficacy and safety of amphotericin B deoxycholate versus N-methylglucamine antimoniate in pediatric visceral leishmaniasis: an open-label, randomized, and controlled pilot trial in Brazil.
Borges, MM; Carranza-Tamayo, CO; Noronha, EF; Pranchevicius, MC; Romero, GA,
)
0.13
"N-methylglucamine antimoniate and amphotericin B deoxycholate have similar efficacy and adverse events rate in pediatric patients with VL."( Efficacy and safety of amphotericin B deoxycholate versus N-methylglucamine antimoniate in pediatric visceral leishmaniasis: an open-label, randomized, and controlled pilot trial in Brazil.
Borges, MM; Carranza-Tamayo, CO; Noronha, EF; Pranchevicius, MC; Romero, GA,
)
0.13
" However, the emergence of severe adverse effects, such as nephrotoxicity, hepatotoxicity and hemolytic anemia, can limit its clinical use."( Assessment of in vitro antifungal efficacy and in vivo toxicity of Amphotericin B-loaded PLGA and PLGA-PEG blend nanoparticles.
Altmeyer, C; Maissar Khalil, N; Mara Mainardes, R; Moraes Moreira Carraro, TC, 2017
)
0.46
"The development of an effective amphotericin B (AmB) topical formulation to replace the systemically toxic injections currently used in cutaneous leishmaniasis (CL) treatment is challenging due to poor absorption through the skin."( Novel and safe single-dose treatment of cutaneous leishmaniasis with implantable amphotericin B-loaded microparticles.
Pacienza-Lima, W; Ré, MI; Rossi-Bergmann, B; Sousa-Batista, AJ, 2019
)
0.51
" We conducted a retrospective descriptive study describing the effectiveness and adverse effects of AB deoxycholate (ABD), AB colloidal dispersion (ABCD), and liposomal AB (LAB) as third-line treatments for CL and MCL."( Effectiveness and Safety of Amphotericin B Deoxycholate, Amphotericin B Colloidal Dispersion, and Liposomal Amphotericin B as Third-Line Treatments for Cutaneous and Mucocutaneous Leishmaniasis: A Retrospective Study.
Casas Vargas, MY; Ordoñez Rubiano, MF; Pérez Franco, JE; Rodríguez Galvis, MC, 2020
)
0.56
"Cryptococcosis is a life-threatening fungal infection, and its current treatment is toxic and subject to resistance."( N-acetylcysteine reduces amphotericin B deoxycholate nephrotoxicity and improves the outcome of murine cryptococcosis.
Carmo, PHF; Carvalho, VSD; Costa, MC; de Brito, CB; de Resende-Stoianoff, MA; de Souza, DG; Emídio, ECP; Ferreira, GF; Freitas, GJC; Holanda, RA; Magalhães, TFF; Paixão, TA; Ribeiro, NQ; Rocha, CEV; Santos, DA, 2020
)
0.56
" We carried out an update of a previous systematic review of all published clinical trials in visceral leishmaniasis (VL) from 1980 to 2019 to document any reported serious adverse events (SAEs)."( Serious adverse events following treatment of visceral leishmaniasis: A systematic review and meta-analysis.
Alves, F; Brack, M; Dahal, P; Guerin, PJ; Halleux, CM; Hawryszkiewycz, A; Maguire, BJ; Ngu, R; Olliaro, PL; Rashan, S; Singh-Phulgenda, S; Stepniewska, K, 2021
)
0.62

Pharmacokinetics

ExcerptReferenceRelevance
"0 mg/kg), by comparison, achieved a lower Cmax (4."( Pharmacokinetics and safety of a unilamellar liposomal formulation of amphotericin B (AmBisome) in rabbits.
Amantea, MA; Bacher, J; Francis, PA; Lee, JW; Navarro, EE; Pizzo, PA; Walsh, TJ, 1994
)
0.29
"The pharmacokinetic profiles of a traditional formulation of amphotericin B (Fungizone) and novel nanosphere and mixed micelle delivery systems developed for amphotericin B were compared and described."( Comparative pharmacokinetics, tissue distributions, and effects on renal function of novel polymeric formulations of amphotericin B and amphotericin B-deoxycholate in rats.
Barturen, C; Dios-Viéitez, MC; Echevarría, I; Renedo, MJ; Trocóniz, IF, 2000
)
0.31
"Model independent pharmacokinetic analysis of intravenous (iv) amphotericin B cochleates (CAMB), a new lipid-based drug delivery system, in mice (0."( Pharmacokinetics and tissue distribution after intravenous administration of a single dose of amphotericin B cochleates, a new lipid-based delivery system.
Movshin, DA; Segarra, I; Zarif, L, 2002
)
0.31
" The present study compares the pharmacokinetic characteristics of D-AmB with the alternative formulation of AmB in microemulsion (M-AmB), which has proved effective in a murine candidiasis model."( Comparative pharmacokinetics and safety of a novel lyophilized amphotericin B lecithin-based oil-water microemulsion and amphotericin B deoxycholate in animal models.
Ballesteros, MP; Brime, B; Bringas, P; Frutos, G; Frutos, P; Nieto, A, 2003
)
0.32
" In vitro and in vivo pharmacodynamic (PD) data, however, do not consistently support the concept of CI dosing based on the concentration-dependent activity of this agent and in vitro studies with AMB rarely account for the drug's high degree of protein binding."( In vitro pharmacodynamics of rapid versus continuous infusion of amphotericin B deoxycholate against Candida species in the presence of human serum albumin.
Kontoyiannis, DP; Lewis, RE; Prince, RA; Wiederhold, NP, 2006
)
0.33
" A one-compartment in vitro pharmacodynamic model was used to simulate the steady-state PK parameters of bolus and CI AMB."( In vitro pharmacodynamics of rapid versus continuous infusion of amphotericin B deoxycholate against Candida species in the presence of human serum albumin.
Kontoyiannis, DP; Lewis, RE; Prince, RA; Wiederhold, NP, 2006
)
0.33
" Pharmacokinetic parameter estimates were determined by a nonparametric population pharmacokinetic analysis of plasma drug concentrations following single intraperitoneal doses (0."( Pharmacodynamic activity of amphotericin B deoxycholate is associated with peak plasma concentrations in a neutropenic murine model of invasive pulmonary aspergillosis.
Chi, J; Kontoyiannis, DP; Lewis, RE; Prince, RA; Tam, VH; Wiederhold, NP, 2006
)
0.33
" Pharmacokinetic studies revealed that subsequent to administration of various formulations of amphotericin B, there was 32 mg/L amphotericin B in the systemic circulation of mice treated with tuftsin-bearing amphotericin B liposomes, while it was 25 mg/L for amphotericin B liposomes, 4 h post drug administration."( Toxicity, stability and pharmacokinetics of amphotericin B in immunomodulator tuftsin-bearing liposomes in a murine model.
Khan, MA; Owais, M, 2006
)
0.33
" Pharmacokinetic parameters in plasma were derived by model-independent techniques, and concentrations in ELF and PAM were calculated based on the urea dilution method and macrophage cell volume, respectively."( Compartmentalized intrapulmonary pharmacokinetics of amphotericin B and its lipid formulations.
Alfaro, RM; Armstrong, D; Bacher, J; Groll, AH; Lyman, CA; Mickiene, D; Petraitiene, R; Petraitis, V; Schaufele, RL; Sein, T; Walsh, TJ, 2006
)
0.33
"The pharmacodynamic and pharmacokinetic (PK-PD) properties of amphotericin B (AmB) formulations against invasive pulmonary aspergillosis (IPA) are not well understood."( Pharmacokinetics and pharmacodynamics of amphotericin B deoxycholate, liposomal amphotericin B, and amphotericin B lipid complex in an in vitro model of invasive pulmonary aspergillosis.
Goodwin, J; Gregson, L; Hope, WW; Howard, SJ; Jensen, GM; Lestner, JM; Majithiya, J; Walsh, TJ, 2010
)
0.36
" The goals of this work were to develop and evaluate a physiologically based pharmacokinetic (PBPK) model to characterize the disposition properties of AmB administered as deoxycholate formulation in healthy rats and to examine the utility of the PBPK model for interspecies scaling of AmB pharmacokinetics."( Physiologically based pharmacokinetic model of amphotericin B disposition in rats following administration of deoxycholate formulation (Fungizone®): pooled analysis of published data.
Gershkovich, P; Kagan, L; Mager, DE; Wasan, KM, 2011
)
0.37
" Its long terminal half-life and retention in tissues suggest that single or intermittent dosing regimens are feasible, and these should be actively investigated in both preclinical models and in clinical trials."( Liposomal Amphotericin B (AmBisome(®)): A Review of the Pharmacokinetics, Pharmacodynamics, Clinical Experience and Future Directions.
Bicanic, T; Hope, W; Salim, R; Stone, NR, 2016
)
0.43

Compound-Compound Interactions

ExcerptReferenceRelevance
"The therapeutic efficacy of caspofungin alone and in combination with amphotericin B deoxycholate was evaluated in treatment of murine coccidioidomycosis."( Therapeutic efficacy of caspofungin alone and in combination with amphotericin B deoxycholate for coccidioidomycosis in a mouse model.
González, G; González, GM; Graybill, JR; Najvar, LK, 2007
)
0.34
"This study indicates that caspofungin has efficacy against systemic coccidioidomycosis in a murine model given in combination with amphotericin B deoxycholate."( Therapeutic efficacy of caspofungin alone and in combination with amphotericin B deoxycholate for coccidioidomycosis in a mouse model.
González, G; González, GM; Graybill, JR; Najvar, LK, 2007
)
0.34
" Mycograb C28Y variant, a human recombinant antibody fragment to heat shock protein 90, is closely related to Mycograb, which showed a survival advantage in combination with AMB in a phase III human trial."( Dose range evaluation of Mycograb C28Y variant, a human recombinant antibody fragment to heat shock protein 90, in combination with amphotericin B-desoxycholate for treatment of murine systemic candidiasis.
Conde, H; Drusano, GL; Fregeau, C; Liu, W; Louie, A; Stein, DS; Vanscoy, BD; Zack, JZ, 2011
)
0.37
" The relevant transport systems were then investigated in terms of the drug-drug interactions of AmB-DOC with antivirals that might potentially be used concomitantly."( Renal handling of amphotericin B and amphotericin B-deoxycholate and potential renal drug-drug interactions with selected antivirals.
Kočíncová, J; Mandíková, J; Trejtnar, F; Volková, M, 2014
)
0.4
" Laboratory adverse events (grade 3 or 4), such as severe anemia, were less frequent with VCZ + 5FC use than with AmB-D combined with 5FC or Flu use."( Comparison of amphotericin B deoxycholate in combination with either flucytosine or fluconazole, and voriconazole plus flucytosine for the treatment of HIV-associated cryptococcal meningitis: a prospective multicenter study in China.
Chen, Y; Harypursat, V; Lan, K; Lu, Y; Wu, Y; Xu, X; Yang, T; Yu, J; Zeng, Q; Zhang, W; Zhao, T; Zhou, G, 2022
)
0.72
"Our results suggest that AmB-D combined with 5FC remains the more efficacious induction regimen compared to AmB-D plus Flu, and that VCZ + 5FC might be a potential alternative when the standard regimen is not readily available, accessible, tolerated, or effective."( Comparison of amphotericin B deoxycholate in combination with either flucytosine or fluconazole, and voriconazole plus flucytosine for the treatment of HIV-associated cryptococcal meningitis: a prospective multicenter study in China.
Chen, Y; Harypursat, V; Lan, K; Lu, Y; Wu, Y; Xu, X; Yang, T; Yu, J; Zeng, Q; Zhang, W; Zhao, T; Zhou, G, 2022
)
0.72

Bioavailability

ExcerptReferenceRelevance
"Miltefosine is an alkyl phosphocholine with good oral bioavailability and in vitro activity against Cryptococcus species that has gained interest as an additional agent for cryptococcal infections."( Limited activity of miltefosine in murine models of cryptococcal meningoencephalitis and disseminated cryptococcosis.
Bocanegra, R; Kirkpatrick, WR; Najvar, LK; Patterson, TF; Sorrell, TC; Wiederhold, NP, 2013
)
0.39

Dosage Studied

ExcerptRelevanceReference
" The use and dosage of conventional amphotericin B (deoxycholate-suspended formulation) is limited by its toxicity, especially nephrotoxicity."( [Remission of invasive sinusal and pulmonary aspergillosis with liposomal amphotericin B in a patient with chronic lymphatic leukemia following failure with conventional amphotericin].
Acebedo, G; Jodar, JM; López, A; Palacio, C, 1994
)
0.29
" Clinical trials in humans must examine carefully the therapeutic-toxic ratio in dose-escalation protocols to determine the optimal dosage strategy for this agent."( Amphotericin B lipid complex in the treatment of experimental cryptococcal meningitis and disseminated candidosis.
Perfect, JR; Wright, KA, 1994
)
0.29
" This study showed that amphotericin B should be given at a dosage of 1 mg/kg bw/day for 20 days for Indian kala-azar patients to minimise relapses and prevent development of drug unresponsiveness."( Comparison of regimens of amphotericin B deoxycholate in kala-azar.
Pandey, AK; Sinha, GP; Thakur, CP, 1996
)
0.29
" In addition, both AmBisome regimens reduced hepatosplenic dissemination, and the 10 m/kg dosage fully prevented this complication."( Liposomal amphotericin B (AmBisome) reduces dissemination of infection as compared with amphotericin B deoxycholate (Fungizone) in a rate model of pulmonary aspergillosis.
Bakker-Woudenberg, IA; de Marie, S; Leenders, AC; ten Kate, MT; Verbrugh, HA, 1996
)
0.29
" Forty-six patients were assigned to receive Intralipid/amphotericin B at a 50% higher dosage (1 mg/[kg."( Randomized comparison of amphotericin B deoxycholate dissolved in dextrose or Intralipid for the treatment of AIDS-associated cryptococcal meningitis.
Aboulker, JP; Aubry, P; Carrière, I; Coulaud, JP; Joly, V; Kawa, E; Larouze, B; Mlika-Cabanne, N; Ndayiragide, A; Yeni, P, 1996
)
0.29
" The optimal dosage of L-nystatin was 5 mg/kg daily on days 1, 2, 4, and 7 (90% survival)."( Dose range evaluation of liposomal nystatin and comparisons with amphotericin B and amphotericin B lipid complex in temporarily neutropenic mice infected with an isolate of Aspergillus fumigatus with reduced susceptibility to amphotericin B.
Denning, DW; Warn, P, 1999
)
0.3
" However, a 24-hour dosing regimen of AmB may be well tolerated even in these patients."( Tolerability, safety and efficacy of conventional amphotericin B administered by 24-hour infusion to lung transplant recipients.
Boehler, A; Dutly, A; Naef, R; Russi, EW; Speich, R; Weder, W, 2002
)
0.31
" Except for the kidneys, the mean concentrations of LNYS in liver, spleen, and lung 24 h after dosing were severalfold lower than those after administration of DAMB (P, <0."( Comparative drug disposition, urinary pharmacokinetics, and renal effects of multilamellar liposomal nystatin and amphotericin B deoxycholate in rabbits.
Alfaro, RM; Groll, AH; King, C; Mickiene, D; Petraitiene, R; Petraitis, V; Piscitelli, SC; Walsh, TJ, 2003
)
0.32
" Dogs were treated twice weekly with an increasing dosage of amphotericin (0."( Initial and long-term efficacy of a lipid emulsion of amphotericin B desoxycholate in the management of canine leishmaniasis.
Cortadellas, O,
)
0.13
"Recent open label studies have suggested that dosing amphotericin B (AMB) by continuous infusion (CI) may reduce drug-associated infusion reactions and nephrotoxicity."( In vitro pharmacodynamics of rapid versus continuous infusion of amphotericin B deoxycholate against Candida species in the presence of human serum albumin.
Kontoyiannis, DP; Lewis, RE; Prince, RA; Wiederhold, NP, 2006
)
0.33
" No substantial differences in the rate or extent of AMB killing were observed between rapid infusion or CI dosing and neither regimen produced fungicidal activity in the presence of HSA."( In vitro pharmacodynamics of rapid versus continuous infusion of amphotericin B deoxycholate against Candida species in the presence of human serum albumin.
Kontoyiannis, DP; Lewis, RE; Prince, RA; Wiederhold, NP, 2006
)
0.33
" In our model, CI and rapid infusion dosing of AMB exhibited similar activity when attempts were made to correct for protein binding that is likely to occur in vivo."( In vitro pharmacodynamics of rapid versus continuous infusion of amphotericin B deoxycholate against Candida species in the presence of human serum albumin.
Kontoyiannis, DP; Lewis, RE; Prince, RA; Wiederhold, NP, 2006
)
0.33
" Three dosage groups (0."( Pharmacodynamic activity of amphotericin B deoxycholate is associated with peak plasma concentrations in a neutropenic murine model of invasive pulmonary aspergillosis.
Chi, J; Kontoyiannis, DP; Lewis, RE; Prince, RA; Tam, VH; Wiederhold, NP, 2006
)
0.33
"In this study, rational dosing guidelines for amphotericin B-deoxycholate (AmB) are proposed for children."( Amphotericin B dose optimization in children with malignant diseases.
Coakley, JC; Earl, JW; McLachlan, AJ; Nath, CE; Shaw, PJ, 2007
)
0.34
" As illustrated in published reports, a higher dose of L-AmB may be prescribed in the case of unresponsiveness to treatment at normal dosage levels."( Use of high-dose liposomal amphotericin B: efficacy and tolerance.
Adam, A; Garbino, J, 2006
)
0.33
"The D-AMB-coated PLGA-DMSA nanoparticle showed antifungal efficacy, fewer undesirable effects and a favourable extended dosing interval."( Amphotericin B in poly(lactic-co-glycolic acid) (PLGA) and dimercaptosuccinic acid (DMSA) nanoparticles against paracoccidioidomycosis.
Amaral, AC; Bentes, R; Bocca, AL; Felipe, MS; Lacava, ZG; Morais, PC; Nunes, J; Peixoto, DL; Primo, FL; Ribeiro, AM; Simioni, AR; Tedesco, AC; Titze-de-Almeida, R, 2009
)
0.35
" Significantly fewer patients who received the 3 mg/kg/day dosage of liposomal amphotericin B developed nephrotoxicity, indicated by a doubling of the serum creatinine value, compared with recipients of conventional amphotericin B (P = ."( Comparison of 2 doses of liposomal amphotericin B and conventional amphotericin B deoxycholate for treatment of AIDS-associated acute cryptococcal meningitis: a randomized, double-blind clinical trial of efficacy and safety.
Barker, DE; El-Sadr, W; Graybill, JR; Hamill, RJ; Javaly, K; Johnson, PC; Sobel, JD, 2010
)
0.36
" This finding may be related to inadequate penetration of amphotericin B lipid products into the kidneys, inappropriate dosing in premature infants, or unknown differences in acuity of illness in infants treated with amphotericin B lipid products."( Antifungal therapy and outcomes in infants with invasive Candida infections.
Ascher, SB; Benjamin, DK; Clark, RH; Cohen-Wolkowiez, M; Moran, C; Smith, PB; Watt, K, 2012
)
0.38
" In 10-day studies dosing uninfected mice, minor renal tubular changes occurred after AmBisome or Abelcet at 1, 5, or 10 mg/kg with or without cyclophosphamide treatment; nephrosis occurred only with Abelcet in cyclophosphamide-treated mice."( Experimental central nervous system aspergillosis therapy: efficacy, drug levels and localization, immunohistopathology, and toxicity.
Clemons, KV; Schwartz, JA; Stevens, DA, 2012
)
0.38
"The dosing differences between nonliposomal and liposomal preparations of amphotericin B can be as high as 50-fold."( Survival after amphotericin B overdose treated with plasmapheresis.
Banerji, S; Heard, KJ; Roussil, TK; Wang, GS, 2013
)
0.39
" Further pharmacokinetic and pharmacodynamic studies of the drug in children could also provide information for rational dosing regimens designed to decrease nephrotoxicity."( Deoxycholate amphotericin B and nephrotoxicity in the pediatric setting.
Arrizurieta, E; Bes, DF; Rosanova, MT; Sberna, N, 2014
)
0.4
" Fewer than one-half of the patients (n=371) received a TDD within the dosing range recommended in the current guidelines."( Systemic antifungal prescribing in neonates and children: outcomes from the Antibiotic Resistance and Prescribing in European Children (ARPEC) Study.
Bielicki, J; Doerholt, K; Goossens, H; Lestner, JM; Roilides, E; Sharland, M; Versporten, A; Warris, A, 2015
)
0.42
" Advances in pharmacokinetics (PK) and pharmacodynamics (PD) of antimicrobial medications have led to improved dosing guidance for neonates."( New antifungal and antiviral dosing.
Monk, HM; Wade, KC, 2015
)
0.42
" A clinical dosage of liposomal amphotericin B of 3 mg/kg/day is predicted to cause complete suppression of galactomannan and (1 → 3)-β-D-glucan levels in the majority of patients."( Pharmacodynamics of amphotericin B deoxycholate, amphotericin B lipid complex, and liposomal amphotericin B against Aspergillus fumigatus.
Al-Nakeeb, Z; Goodwin, J; Hope, WW; Petraitiene, R; Petraitis, V; Walsh, TJ, 2015
)
0.42
" In vitro, experimental animal models and human clinical trial data are summarized, and novel routes of administration and dosing schedules are discussed."( Liposomal Amphotericin B (AmBisome(®)): A Review of the Pharmacokinetics, Pharmacodynamics, Clinical Experience and Future Directions.
Bicanic, T; Hope, W; Salim, R; Stone, NR, 2016
)
0.43
" Renal and hepatic markers were raised for Fungizone®-like formulation-treated rats but not for AmB-SDCS formulations following 7 days of regular dosing by intratracheal instillation."( Biodistribution and histopathology studies of amphotericin B sodium deoxycholate sulfate formulation following intratracheal instillation in rat models.
Javed, I; Nopparat, J; Srichana, T; Usman, F, 2020
)
0.56
" To standardize the clinical application of AmBd, well-known experts in this field were invited to reach a consensus on the antifungal properties, pharmacokinetic characteristics, dosage regimen, clinical application, prevention and treatment of adverse reactions of AmBd."( [Expert consensus on rational clinical application of amphotericin B deoxycholate (2022)].
, 2023
)
0.91
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (316)

TimeframeStudies, This Drug (%)All Drugs %
pre-19902 (0.63)18.7374
1990's34 (10.76)18.2507
2000's110 (34.81)29.6817
2010's140 (44.30)24.3611
2020's30 (9.49)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials29 (8.76%)5.53%
Reviews55 (16.62%)6.00%
Case Studies62 (18.73%)4.05%
Observational4 (1.21%)0.25%
Other181 (54.68%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (14)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Multicentric Efficacy and Safety Study of Antileishmanial Drugs for Treatment of Visceral Leishmaniasis in Brazil [NCT01310738]Phase 4378 participants (Actual)Interventional2011-02-28Terminated(stopped due to DSMB recommendation based on programmed interim analysis.)
A Randomized Study to Evaluate the Safety and Efficacy of Liposomal Amphotericin B and Amphotericin B Deoxycholate With or Without Flucytosine Followed by Fluconazole, for the Treatment of Cryptococcal Meningitis [NCT02136030]84 participants (Anticipated)Interventional2011-02-28Recruiting
Randomized, Open-label, Parallel-group, Safety & Efficacy Study to Evaluate Different Combination Treatment Regimens, of Either AmBisome and Paromomycin, AmBisome and Miltefosine, or Paromomycin and Miltefosine Compared With Amphotericin B Deoxycholate (t [NCT00696969]Phase 3634 participants (Actual)Interventional2008-06-30Completed
Efficacy and Safety of Amphotericin B Deoxycholate Compared to Meglumine Antimoniate for Treatment of Visceral Leishmaniasis in Brazilian Children [NCT01032187]Phase 4101 participants (Actual)Interventional2007-10-31Completed
A Phase 3, Randomized, Double-Blind, Multi-Center Study to Compare the Efficacy and Safety of Micafungin Versus Amphotericin B Deoxycholate for the Treatment of Neonatal Candidiasis [NCT00815516]Phase 330 participants (Actual)Interventional2013-02-28Terminated(stopped due to It was decided to discontinue the study due to insufficient recruitment.)
The Effect and Safety of Three Initial Introduction Treatments on HIV-infected Patients With Cryptococcal Meningitis: A Multi-center, Random and Prospective Study [NCT04072640]Early Phase 1120 participants (Anticipated)Interventional2021-01-25Active, not recruiting
A Phase I/II Dose-Finding Study of High-Dose Fluconazole Treatment in AIDS-Associated Cryptococcal Meningitis [NCT00885703]Phase 1/Phase 2168 participants (Actual)Interventional2010-04-16Completed
A Phase III Randomized, Controlled, Clinical Trial to Assess the Safety and Efficacy of Single Infusion of Liposomal Amphotericin B in Patients With Visceral Leishmaniasis [NCT00628719]Phase 3400 participants (Anticipated)Interventional2008-02-29Completed
A Randomised, Open-label, Parallel-group, Safety and Efficacy Study to Evaluate Different Combination Treatment Regimens (Co-administration), of AmBisome, Paromomycin and Miltefosine in Visceral Leishmaniasis (VL) [NCT00523965]Phase 3624 participants (Anticipated)Interventional2007-09-30Completed
A PROSPECTIVE RANDOMIZED, DOUBLE-BLIND, COMPARATIVE, MULTICENTER STUDY TO EVALUATE EFFICACY AND SAFETY OF NYSTATIN AND AMPHOTERICIN B FOR EMPIRIC ANTIFUNGAL TREATMENT IN NEUTROPENIC PATIENTS [NCT00002742]Phase 30 participants Interventional1996-01-31Completed
Randomised Double Blind Dose Ranging Study of Amphotericin B in Visceral Leishmaniasis [NCT00310505]1,500 participants Interventional2003-01-31Completed
Using Serum Galactomannan Levels in a Prospective, Randomised, Non-blinded Trial to Guide Early Anti-fungal Therapy in Haematology Patients at Risk of Invasive Aspergillosis. [NCT00361517]Phase 347 participants (Actual)Interventional2006-06-01Completed
An Open Randomised Comparative Multicentre Study of the Efficacy, Safety and Toleration of Voriconazole Versus Amphotericin-B in the Treatment of Acute Invasive Aspergillosis in Immunocompromised Patients [NCT00003031]Phase 3212 participants (Anticipated)Interventional1997-06-30Completed
A Multicenter, Double-Blind, Randomized, Comparator-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of Caspofungin Versus Amphotericin B Deoxycholate in the Treatment of Invasive Candidiasis in Neonates and Infants Less Than 3 Months o [NCT01945281]Phase 251 participants (Actual)Interventional2014-01-15Terminated(stopped due to Operational feasibility with low recruitment due to changing epidemiology of disease)
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00815516 (13) [back to overview]Fungal-free Survival
NCT00815516 (13) [back to overview]Fungal-free Survival at End of Study Drug Therapy in Infants With End-organ Dissemination
NCT00815516 (13) [back to overview]Fungal-free Survival One Week After Last Dose of Study Drug in Infants With End-organ Dissemination
NCT00815516 (13) [back to overview]Percentage of Participants With Emergent Fungal Infections
NCT00815516 (13) [back to overview]Percentage of Participants With Recurrent Fungal Infections
NCT00815516 (13) [back to overview]Time to Mycological Clearance of Invasive Candidiasis
NCT00815516 (13) [back to overview]Time to Positive Clinical Response
NCT00815516 (13) [back to overview]Clinical Response at the End of Study Drug Therapy
NCT00815516 (13) [back to overview]Clinical Response One Week After Last Dose of Study Drug
NCT00815516 (13) [back to overview]Follow-up Status for Infants With End-organ Assessments
NCT00815516 (13) [back to overview]Mycological Response at End of Study Drug Therapy
NCT00815516 (13) [back to overview]Mycological Response One Week After Last Dose of Study Drug
NCT00815516 (13) [back to overview]Plasma Micafungin Concentration
NCT00885703 (10) [back to overview]Change in Log10 Quantitative CSF Culture Results
NCT00885703 (10) [back to overview]Kaplan Meier (KM) Proportion of Participant Mortality
NCT00885703 (10) [back to overview]Length of Hospitalization
NCT00885703 (10) [back to overview]Number of Participants Who Discontinued Study-provided High Dose Fluconazole or Ampho B
NCT00885703 (10) [back to overview]Number of Participants With CNS IRIS
NCT00885703 (10) [back to overview]Number of Participants With Progression of Symptoms
NCT00885703 (10) [back to overview]Number of Participants With Grade 3 and 4 Adverse Events
NCT00885703 (10) [back to overview]Results of Functional Status Evaluation
NCT00885703 (10) [back to overview]Categorized Quantitative Culture Results
NCT00885703 (10) [back to overview]Results of the Neurological Examination
NCT01945281 (3) [back to overview]Number of Participants With an Adverse Event (AE)
NCT01945281 (3) [back to overview]Percentage of Participants With Fungal-free Survival Through the 2-week Post-therapy Period
NCT01945281 (3) [back to overview]Percentage of Participants With Fungal-free Survival Through the End of Study Treatment

Fungal-free Survival

"Fungal-free survival was assessed by an independent data review panel (DRP). Fungal-free survival is defined as the percentage of participants alive at one week following the last dose of study drug with a mycological response of eradication and no requirement for alternative systemic antifungal therapy for continued treatment.~Eradication was defined as culture or histologically documented absence of the infecting Candida species from all positive normally sterile sites during therapy, documented by 2 negative samples, drawn at least 24 hours apart, or for Candida meningitis and/or candiduria, 1 negative culture." (NCT00815516)
Timeframe: One week after the last dose of study drug (maximum of 49 days)

Interventionpercentage of participants (Number)
Micafungin60.0
Amphotericin B70.0

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Fungal-free Survival at End of Study Drug Therapy in Infants With End-organ Dissemination

Fungal-free survival was assessed by an independent data review panel (DRP). Fungal-free survival is defined as the percentage of participants alive at the end of study drug therapy with a mycological response of eradication based upon the DRP assessment and no requirement for alternative systemic antifungal therapy for continued treatment. (NCT00815516)
Timeframe: The end of study drug therapy; maximum of 42 days

Interventionpercentage of participants (Number)
Micafungin42.9
Amphotericin B33.3

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Fungal-free Survival One Week After Last Dose of Study Drug in Infants With End-organ Dissemination

Fungal-free survival was assessed by an independent data review panel (DRP). Fungal-free survival is defined as the percentage of participants alive one week after last dose of study drug with a mycological response of eradication based upon the DRP assessment and no requirement for alternative systemic antifungal therapy for continued treatment. (NCT00815516)
Timeframe: One week after the last dose of study drug (maximum of 49 days)

Interventionpercentage of participants (Number)
Micafungin42.9
Amphotericin B33.3

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Percentage of Participants With Emergent Fungal Infections

"An emergent fungal infection is defined as~An invasive fungal infection which is detected at any time during the study that is a non-Candida organism, or~An invasive fungal infection which is detected during the treatment or post-treatment period with a Candida species identified other than those detected at Baseline. If this occurred within 96 hours of the first dose of study drug, the infection was considered part of the final diagnosis of enrolling infection and not an emergent infection." (NCT00815516)
Timeframe: Up to 30 days after the last dose of study drug (maximum of 72 days)

Interventionpercentage of participants (Number)
Micafungin5.0
Amphotericin B0

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Percentage of Participants With Recurrent Fungal Infections

A recurrent infection is defined as a systemic fungal infection in an infant with eradication at the end of study drug therapy, who developed positive blood cultures or a mycologically confirmed deep-seated Candida infection, with the same species as the enrolling infection. (NCT00815516)
Timeframe: Up to 30 days after the last dose of study drug (maximum of 72 days)

Interventionpercentage of participants (Number)
Micafungin0
Amphotericin B12.5

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Time to Mycological Clearance of Invasive Candidiasis

"Time to mycological clearance of invasive candidiasis is defined as the time from first dose to the day of mycological eradication for baseline invasive candidiasis infection.~Eradication was defined as a culture or histologically documented absence of the infecting Candida species from all positive normally sterile sites during therapy, documented by 2 negative samples, drawn at least 24 hours apart, or for for Candida meningitis and/or candiduria, 1 negative culture.~Infants without eradication during the treatment period and who survived were censored at one day after the end of treatment. Infants without eradication who died before completing the treatment period or were lost to follow-up during the treatment were censored at their death or last contact day." (NCT00815516)
Timeframe: From first dose up to 30 days after the last dose of study drug (maximum of 72 days)

Interventiondays (Median)
Micafungin6.0
Amphotericin B3.0

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Time to Positive Clinical Response

"Time to a positive clinical response is defined as the time from the first dose to the day during the treatment period that a positive clinical response (defined as a complete response or partial response) is observed for the first time, assessed by the Investigator.~Complete Response is defined as the resolution of all attributable signs related to fungal infection, if present at baseline and Partial Response is defined as improvement in attributable signs related to the fungal infection, if present at baseline.~Infants without positive responses and who survived were censored at one day post the end of treatment. Infants without positive responses who died before completing the treatment period, or were lost to follow-up during the treatment were censored at their death or last contact day." (NCT00815516)
Timeframe: From first dose up to 30 days after the last dose of study drug (maximum of 72 days)

Interventiondays (Median)
Micafungin8.0
Amphotericin B11.0

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Clinical Response at the End of Study Drug Therapy

"Clinical response assessments were based on the following definitions and assessed by the DRP:~Complete Response: Resolution of all attributable signs related to fungal infection, if present at baseline.~Partial Response: Improvement in attributable signs related to the fungal infection, if present at baseline.~Stabilization: Minor improvement or no change in attributable signs related to the fungal infection, if present at baseline, and infant continued on therapy without deterioration.~Progression: Deterioration in attributable signs related to the fungal infection, if present at baseline; or if death occurred presumably related to a fungal infection." (NCT00815516)
Timeframe: Baseline and end of study drug therapy; maximum of 42 days

,
Interventionpercentage of participants (Number)
CompletePartialStableProgressionMissing
Amphotericin B70.0010.020.00
Micafungin55.65.65.616.716.7

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Clinical Response One Week After Last Dose of Study Drug

"Clinical response assessments were based on the following definitions and assessed by the DRP:~Complete Response: Resolution of all attributable signs related to fungal infection, if present at baseline.~Partial Response: Improvement in attributable signs related to the fungal infection, if present at baseline.~Stabilization: Minor improvement or no change in attributable signs related to the fungal infection, if present at baseline, and infant continued on therapy without deterioration.~Progression: Deterioration in attributable signs related to the fungal infection, if present at baseline; or if death occurred presumably related to a fungal infection." (NCT00815516)
Timeframe: Baseline and one week after the last dose of study drug (maximum of 49 days)

,
Interventionpercentage of participants (Number)
CompletePartialStableProgressionMissing
Amphotericin B70.0010.020.00
Micafungin55.65.65.65.627.8

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Follow-up Status for Infants With End-organ Assessments

"End-organ dissemination was assessed through abdominal ultrasound and/or computed tomography (CT), echocardiogram, head imaging and retinal exam. Each specific finding, documented by 1 of these techniques, was evaluated as follows:~Improvement: Improvement in size, number or density of identified lesions. Complete response was not expected but may have been documented.~Stabilization: Minor improvement or no change in size, number or density of identified lesions.~Worsening: Increase in size or number of identified lesions." (NCT00815516)
Timeframe: Baseline and 30 days after the last dose of study drug (maximum of 72 days)

,
Interventionpercentage of participants (Number)
ImprovedStableWorsenedNot Assessed
Amphotericin B33.3066.70
Micafungin57.114.314.314.3

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Mycological Response at End of Study Drug Therapy

"Mycological response assessments were based on the following definitions and assessed by the DRP:~Eradication: Culture or histologically documented absence of the infecting Candida species from all positive normally sterile sites during therapy, documented by 2 negative samples, drawn at least 24 h apart; for Candida meningitis and/or candiduria, 1 negative culture.~Persistence: Continued isolation or histological documentation from a normally sterile site." (NCT00815516)
Timeframe: End of study drug therapy; maximum of 42 days

,
Interventionpercentage of participants (Number)
EradicationPersistenceNot Assessed
Amphotericin B80.020.00
Micafungin55.010.035.0

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Mycological Response One Week After Last Dose of Study Drug

"Mycological response assessments were based on the following definitions and assessed by the DRP:~Eradication: Culture or histologically documented absence of the infecting Candida species from all positive normally sterile sites during therapy, documented by 2 negative samples, drawn at least 24 h apart; for Candida meningitis and/or candiduria, 1 negative culture.~Persistence: Continued isolation or histological documentation from a normally sterile site." (NCT00815516)
Timeframe: One week after the last dose of study drug (maximum of 49 days)

,
Interventionpercentage of participants (Number)
Continuing Eradication/EradicationPersistenceNot Assessed
Amphotericin B80.020.00
Micafungin55.010.035.0

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Plasma Micafungin Concentration

(NCT00815516)
Timeframe: 15 minutes post intravenous infusion (IV), 4-8 hours post IV and 15-24 hours post IV

Interventionng/mL (Mean)
Within 15 Minutes Post IV4-8 Hours Post IV15-24 Hours Post IV
Micafungin25130.523751.714118.3

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Change in Log10 Quantitative CSF Culture Results

"Change in quantitative CSF (cerebrospinal fluid) cultures.~Note: No further CSF specimens are drawn following a negative culture. Thus, only week 2 CSF cultures are considered in this analysis." (NCT00885703)
Timeframe: Entry and Week 2

InterventionLog10 CFU/mL (Median)
Fluconazole 1200mg-1.51
Fluconazole 1600mg-2.51
Fluconazole 2000mg-1.78
Ampho B-2.81

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Kaplan Meier (KM) Proportion of Participant Mortality

Kaplan Meier Proportion of participants who died over study with 90% Confidence Intervals. (NCT00885703)
Timeframe: Measured from study entry through Week 24

Interventionproportion of participants (Number)
Fluconazole 1200mg0.41
Fluconazole 1600mg0.30
Fluconazole 2000mg0.36
Ampho B0.24

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Length of Hospitalization

Duration of first hospitalization in days starting at entry in safety population. (NCT00885703)
Timeframe: Measured from study entry through Week 10

InterventionDays (Median)
Fluconazole 1200mg15
Fluconazole 1600mg17.5
Fluconazole 2000mg18
Ampho B18.5

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Number of Participants Who Discontinued Study-provided High Dose Fluconazole or Ampho B

"Discontinuation of study-provided high dose fluconazole at or by week 10 Discontinuation of study-provided ampho B at or by week 2~Discontinuation includes discontinuing for any reason, including progression of symptoms, death, etc." (NCT00885703)
Timeframe: Measured from study entry through Week10

InterventionParticipants (Count of Participants)
Stage 1, Fluconazole 1200mg14
Stage 1, Fluconazole 1600mg11
Stage 1, Fluconazole 2000mg11
Stage 1, Ampho B6
Stage 2, Fluconazole 1600mg12
Stage 2, Fluconazole 2000mg13
Stage 2, Ampho B6

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Number of Participants With CNS IRIS

Number of participants who were diagnosed with CNS immune reconstitution inflammatory syndrome (IRIS) (NCT00885703)
Timeframe: Measured from study entry through Week 24

InterventionParticipants (Count of Participants)
Fluconazole 1200mg1
Fluconazole 1600mg0
Fluconazole 2000mg0
Ampho B1

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Number of Participants With Progression of Symptoms

"Progression of symptoms is defined as:~Died (including early deaths)~Discontinued Fluconazole and started ampho B~Had a positive cryptococcal culture at week 10~Microbiological Failure (i.e., relapse of CM)~Complication of CM (e.g., obstructive hydrocephalus or vascular complications such as venous or arterial thrombosis)~CM IRIS causing increased inflammation after ART exposure~New CNS Ol (e.g., toxoplasmosis, PML, CNS lymphoma)~Possibly related to CM but mechanism indeterminate~Other defined complication unrelated to CM" (NCT00885703)
Timeframe: Measured from study entry through Week 24

InterventionParticipants (Count of Participants)
Fluconazole 1200mg14
Fluconazole 1600mg21
Fluconazole 2000mg24
Ampho B19

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Number of Participants With Grade 3 and 4 Adverse Events

"Occurrence of grade 3 (severe) and 4 (life-threatening) sign and symptoms events (as defined by FSTRF Appendix 29)~Occurrence of grade 3 (severe) and 4 (life-threatening) laboratory events (as defined by FSTRF Appendix 76)~See DAIDS AE Grading table V1.0" (NCT00885703)
Timeframe: Measured from study entry through Week 24

,,,
InterventionParticipants (Count of Participants)
Sign/Symptom EventsLaboratory Events
Ampho B2430
Fluconazole 1200mg1612
Fluconazole 1600mg2327
Fluconazole 2000mg3226

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Results of Functional Status Evaluation

"Functional assessment of work status and ability. Consists of 2 measures: 1) Does participants have full time work status 2) Does participant have functional ability to work.~The measure from 6 week before enrollment will be referred to as 'baseline'." (NCT00885703)
Timeframe: Measured 6 weeks before enrollment, at study entry, at Week 10, and at Week 24

,,,
InterventionParticipants (Count of Participants)
Baseline Had full time work statusEntry Had full time work statusWeek 10 Had full time work statusWeek 24 Had full time work statusBaseline Had functional ability to workEntry Had functional ability to workWeek 10 Had functional ability to workWeek 24 Had functional ability to work
Ampho B42913223871524
Fluconazole 1200mg1833716147
Fluconazole 1600mg41916184181819
Fluconazole 2000mg368917323916

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Categorized Quantitative Culture Results

Count of participants who were CM negative (had no cryptococcal growth), CM negative after switching treatment (switched from Fluconazole to Ampho B or vice versa and later became CM negative), CM positive, Died, Lost to follow-up. Note: CM positive means continued to have cryptococcal growth. (NCT00885703)
Timeframe: At entry, Week 2, and Week 10

InterventionParticipants (Count of Participants)
Week 072337496Week 072337498Week 072337499Week 072337497Week 272337496Week 272337497Week 272337498Week 272337499Week 1072337496Week 1072337497Week 1072337498Week 1072337499
CM Negative after switching treatmentDiedLost to Follow-upCM PositiveCM Negative
Fluconazole 1200mg20
Fluconazole 1600mg45
Fluconazole 2000mg43
Ampho B46
Fluconazole 1200mg0
Fluconazole 2000mg0
Ampho B0
Fluconazole 1600mg0
Fluconazole 1200mg12
Fluconazole 1600mg27
Fluconazole 2000mg27
Ampho B29
Fluconazole 1600mg12
Fluconazole 2000mg10
Ampho B13
Fluconazole 1200mg5
Fluconazole 1600mg6
Fluconazole 2000mg6
Ampho B4
Fluconazole 1200mg3
Fluconazole 1600mg4
Fluconazole 2000mg3
Ampho B2
Fluconazole 1200mg8
Fluconazole 1600mg24
Fluconazole 2000mg22
Ampho B37
Fluconazole 1200mg1
Fluconazole 2000mg5
Fluconazole 1600mg10
Fluconazole 2000mg12
Ampho B5
Fluconazole 1600mg3
Fluconazole 2000mg1
Ampho B1

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Results of the Neurological Examination

Results from Glasgow Coma Score, which provides assessment of impairment of conscious level in response to defined stimuli. Min score of 0 and max score of 15 (no mental impairment). (NCT00885703)
Timeframe: Measured at study entry, Week 2, and Week 10

InterventionParticipants (Count of Participants)
Week 072337496Week 072337497Week 072337498Week 072337499Week 272337496Week 272337497Week 272337498Week 272337499Week 1072337497Week 1072337498Week 1072337496Week 1072337499
Score = 15Score < 15
Fluconazole 1200mg5
Fluconazole 1600mg5
Fluconazole 2000mg5
Ampho B1
Fluconazole 1200mg17
Fluconazole 1600mg45
Fluconazole 2000mg42
Ampho B47
Fluconazole 1200mg2
Fluconazole 1600mg4
Fluconazole 2000mg4
Ampho B5
Fluconazole 1200mg15
Fluconazole 1600mg38
Fluconazole 2000mg36
Ampho B38
Fluconazole 1200mg1
Fluconazole 1600mg1
Fluconazole 2000mg1
Ampho B0
Fluconazole 1200mg11
Fluconazole 1600mg33
Fluconazole 2000mg26
Ampho B34

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Number of Participants With an Adverse Event (AE)

An AE is any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product, is also an AE. (NCT01945281)
Timeframe: 8 weeks after end of study therapy (up to 146 days)

InterventionParticipants (Count of Participants)
Caspofungin28
Amphotericin B Deoxycholate16

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Percentage of Participants With Fungal-free Survival Through the 2-week Post-therapy Period

Fungal-free survival is those participants who survived up to 2 weeks post-therapy, and had documented microbiological eradication of Candida species (sp.) from follow-up cultures collected after the initiation of study therapy. Microbiological eradication denotes negative follow-up cultures for Candida sp. from the site of infection. If a culture is not obtained on the day of assessment, the last culture after study entry may be used to assist in the assessment of microbiological eradication. If the last culture is negative for Candida sp., then microbiological eradication would be considered achieved. (NCT01945281)
Timeframe: Up to 104 days

InterventionPercentage of Participants (Number)
Caspofungin71.0
Amphotericin B Deoxycholate68.8

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Percentage of Participants With Fungal-free Survival Through the End of Study Treatment

Fungal-free survival is those participants who survived up to end of study treatment, and had documented microbiological eradication of Candida sp. from follow-up cultures collected after the initiation of study therapy. Microbiological eradication denotes negative follow-up cultures for Candida sp. from the site of infection. If a culture is not obtained on the day of assessment, the last culture after study entry may be used to assist in the assessment of microbiological eradication. If the last culture is negative for Candida sp., then microbiological eradication would be considered achieved. (NCT01945281)
Timeframe: Up to 90 days

InterventionPercentage of Participants (Number)
Caspofungin71.0
Amphotericin B Deoxycholate75.0

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