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Single High Dose of Liposomal Amphotericin B in Human Immunodeficiency Virus/AIDS-Related Disseminated Histoplasmosis: A Randomized Trial.
- Source :
-
Clinical Infectious Diseases . 10/15/2023, Vol. 77 Issue 8, p1126-1132. 7p. - Publication Year :
- 2023
-
Abstract
- Background Histoplasmosis is a major AIDS-defining illness in Latin America. Liposomal amphotericin B (L-AmB) is the drug of choice for treatment, but access is restricted due to the high drug and hospitalization costs of the conventional long regimens. Methods Prospective randomized multicenter open-label trial of 1- or 2-dose induction therapy with L-AmB versus control for disseminated histoplasmosis in AIDS, followed by oral itraconazole therapy. We randomized subjects to: (i) single dose 10 mg/kg of L-AmB; (ii) 10 mg/kg of L-AmB on D1, and 5 mg/kg of L-AmB on D3; (iii) 3 mg/kg of L-AmB daily for 2 weeks (control). The primary outcome was clinical response (resolution of fever and signs/symptoms attributable to histoplasmosis) at day 14. Results A total of 118 subjects were randomized, and median CD4+ counts, and clinical presentations were similar between arms. Infusion-related toxicity, kidney toxicity at multiple time-points, and frequency of anemia, hypokalemia, hypomagnesemia, and liver toxicity were similar. Day 14 clinical response was 84% for single-dose L-AmB, 69% 2-dose L-AmB, and 74% for control arm (P =.69). Overall survival on D14 was 89.0% (34/38) for single-dose L-AmB, 78.0% (29/37) for 2-dose L-AmB, and 92.1% (35/38) for control arm (P =.82). Conclusions One day induction therapy with 10 mg/kg of L-AmB in AIDS-related histoplasmosis was safe. Although clinical response may be non-inferior to standard L-AmB therapy, a confirmatory phase III clinical trial is needed. A single induction dose would markedly reduce drug-acquisition costs (>4-fold) and markedly shorten and simplify treatment, which are key points in terms of increased access. [ABSTRACT FROM AUTHOR]
- Subjects :
- *HIV infection complications
*DRUG efficacy
*HIV-positive persons
*RESEARCH
*AMPHOTERICIN B
*RANDOMIZED controlled trials
*CD4 lymphocyte count
*DESCRIPTIVE statistics
*SURVIVAL analysis (Biometry)
*DOSE-effect relationship in pharmacology
*HISTOPLASMOSIS
*STATISTICAL sampling
*AIDS
*AIDS patients
*OVERALL survival
*LONGITUDINAL method
*DISEASE complications
*EVALUATION
*SYMPTOMS
Subjects
Details
- Language :
- English
- ISSN :
- 10584838
- Volume :
- 77
- Issue :
- 8
- Database :
- Academic Search Index
- Journal :
- Clinical Infectious Diseases
- Publication Type :
- Academic Journal
- Accession number :
- 172993918
- Full Text :
- https://doi.org/10.1093/cid/ciad313