Paromomycin: No more effective than placebo for treatment of cryptosporidiosis in patients with advanced human immunodeficiency virus infection

R. G. Hewitt, Constantin Yiannoutsos, E. S. Higgs, J. T. Carey, P. J. Geiseler, R. Soave, R. Rosenberg, G. J. Vazquez, L. J. Wheat, R. J. Fass, Z. Antoninievic, A. L. Walawander, T. P. Flanigan, J. F. Bender

Research output: Contribution to journalArticle

96 Citations (Scopus)

Abstract

To evaluate the efficacy of paromomycin for the treatment of symptomatic cryptosporidial enteritis in human immunodeficiency virus-infected adults, we conducted a prospective, randomized, double-blind, placebo-controlled trial before the widespread introduction of highly active antiretroviral therapy (HAART). Seven units under the auspices of the AIDS Clinical Trials Group enrolled 35 adults with CD4 cell counts of ≤150/mm3. Initially, 17 patients received paromomycin (500 mg 4 times daily) and 18 received matching placebo for 21 days. Then all patients received paromomycin (500 mg q.i.d.) for an additional 21 days. Clinical definitions of response were measured by an average number of bowel movements per day in association with concurrent need for antidiarrheal agents that was lower than that before study entry. There was no treatment response during the placebo-controlled phase of the study according to protocol-defined criteria (P = .88). Three paromomycin recipients (17.6%) versus 2 placebo recipients (14.3%) responded completely. Rates of combined partial and complete responses in the paromomycin arm (8 out of 17, 47.1%) and the placebo arm (5 out of 14, 35.7%) of the study were also similar (P = .72). The clinical course of cryptosporidiosis was quite variable. Paromomycin was not shown to be more effective than placebo for the treatment of symptomatic cryptosporidial enteritis. However, inadequate statistical power prevents definitive rejection of the usefulness of paromomycin as therapy for this infection.

Original languageEnglish (US)
Pages (from-to)1084-1092
Number of pages9
JournalClinical Infectious Diseases
Volume31
Issue number4
DOIs
StatePublished - 2000
Externally publishedYes

Fingerprint

Paromomycin
Cryptosporidiosis
Virus Diseases
Placebos
HIV
Enteritis
Therapeutics
Antidiarrheals
Highly Active Antiretroviral Therapy
CD4 Lymphocyte Count
Acquired Immunodeficiency Syndrome
Clinical Trials
Infection

ASJC Scopus subject areas

  • Immunology

Cite this

Paromomycin : No more effective than placebo for treatment of cryptosporidiosis in patients with advanced human immunodeficiency virus infection. / Hewitt, R. G.; Yiannoutsos, Constantin; Higgs, E. S.; Carey, J. T.; Geiseler, P. J.; Soave, R.; Rosenberg, R.; Vazquez, G. J.; Wheat, L. J.; Fass, R. J.; Antoninievic, Z.; Walawander, A. L.; Flanigan, T. P.; Bender, J. F.

In: Clinical Infectious Diseases, Vol. 31, No. 4, 2000, p. 1084-1092.

Research output: Contribution to journalArticle

Hewitt, RG, Yiannoutsos, C, Higgs, ES, Carey, JT, Geiseler, PJ, Soave, R, Rosenberg, R, Vazquez, GJ, Wheat, LJ, Fass, RJ, Antoninievic, Z, Walawander, AL, Flanigan, TP & Bender, JF 2000, 'Paromomycin: No more effective than placebo for treatment of cryptosporidiosis in patients with advanced human immunodeficiency virus infection', Clinical Infectious Diseases, vol. 31, no. 4, pp. 1084-1092. https://doi.org/10.1086/318155
Hewitt, R. G. ; Yiannoutsos, Constantin ; Higgs, E. S. ; Carey, J. T. ; Geiseler, P. J. ; Soave, R. ; Rosenberg, R. ; Vazquez, G. J. ; Wheat, L. J. ; Fass, R. J. ; Antoninievic, Z. ; Walawander, A. L. ; Flanigan, T. P. ; Bender, J. F. / Paromomycin : No more effective than placebo for treatment of cryptosporidiosis in patients with advanced human immunodeficiency virus infection. In: Clinical Infectious Diseases. 2000 ; Vol. 31, No. 4. pp. 1084-1092.
@article{80f08add314d4c0e81c445dda10b7134,
title = "Paromomycin: No more effective than placebo for treatment of cryptosporidiosis in patients with advanced human immunodeficiency virus infection",
abstract = "To evaluate the efficacy of paromomycin for the treatment of symptomatic cryptosporidial enteritis in human immunodeficiency virus-infected adults, we conducted a prospective, randomized, double-blind, placebo-controlled trial before the widespread introduction of highly active antiretroviral therapy (HAART). Seven units under the auspices of the AIDS Clinical Trials Group enrolled 35 adults with CD4 cell counts of ≤150/mm3. Initially, 17 patients received paromomycin (500 mg 4 times daily) and 18 received matching placebo for 21 days. Then all patients received paromomycin (500 mg q.i.d.) for an additional 21 days. Clinical definitions of response were measured by an average number of bowel movements per day in association with concurrent need for antidiarrheal agents that was lower than that before study entry. There was no treatment response during the placebo-controlled phase of the study according to protocol-defined criteria (P = .88). Three paromomycin recipients (17.6{\%}) versus 2 placebo recipients (14.3{\%}) responded completely. Rates of combined partial and complete responses in the paromomycin arm (8 out of 17, 47.1{\%}) and the placebo arm (5 out of 14, 35.7{\%}) of the study were also similar (P = .72). The clinical course of cryptosporidiosis was quite variable. Paromomycin was not shown to be more effective than placebo for the treatment of symptomatic cryptosporidial enteritis. However, inadequate statistical power prevents definitive rejection of the usefulness of paromomycin as therapy for this infection.",
author = "Hewitt, {R. G.} and Constantin Yiannoutsos and Higgs, {E. S.} and Carey, {J. T.} and Geiseler, {P. J.} and R. Soave and R. Rosenberg and Vazquez, {G. J.} and Wheat, {L. J.} and Fass, {R. J.} and Z. Antoninievic and Walawander, {A. L.} and Flanigan, {T. P.} and Bender, {J. F.}",
year = "2000",
doi = "10.1086/318155",
language = "English (US)",
volume = "31",
pages = "1084--1092",
journal = "Clinical Infectious Diseases",
issn = "1058-4838",
publisher = "Oxford University Press",
number = "4",

}

TY - JOUR

T1 - Paromomycin

T2 - No more effective than placebo for treatment of cryptosporidiosis in patients with advanced human immunodeficiency virus infection

AU - Hewitt, R. G.

AU - Yiannoutsos, Constantin

AU - Higgs, E. S.

AU - Carey, J. T.

AU - Geiseler, P. J.

AU - Soave, R.

AU - Rosenberg, R.

AU - Vazquez, G. J.

AU - Wheat, L. J.

AU - Fass, R. J.

AU - Antoninievic, Z.

AU - Walawander, A. L.

AU - Flanigan, T. P.

AU - Bender, J. F.

PY - 2000

Y1 - 2000

N2 - To evaluate the efficacy of paromomycin for the treatment of symptomatic cryptosporidial enteritis in human immunodeficiency virus-infected adults, we conducted a prospective, randomized, double-blind, placebo-controlled trial before the widespread introduction of highly active antiretroviral therapy (HAART). Seven units under the auspices of the AIDS Clinical Trials Group enrolled 35 adults with CD4 cell counts of ≤150/mm3. Initially, 17 patients received paromomycin (500 mg 4 times daily) and 18 received matching placebo for 21 days. Then all patients received paromomycin (500 mg q.i.d.) for an additional 21 days. Clinical definitions of response were measured by an average number of bowel movements per day in association with concurrent need for antidiarrheal agents that was lower than that before study entry. There was no treatment response during the placebo-controlled phase of the study according to protocol-defined criteria (P = .88). Three paromomycin recipients (17.6%) versus 2 placebo recipients (14.3%) responded completely. Rates of combined partial and complete responses in the paromomycin arm (8 out of 17, 47.1%) and the placebo arm (5 out of 14, 35.7%) of the study were also similar (P = .72). The clinical course of cryptosporidiosis was quite variable. Paromomycin was not shown to be more effective than placebo for the treatment of symptomatic cryptosporidial enteritis. However, inadequate statistical power prevents definitive rejection of the usefulness of paromomycin as therapy for this infection.

AB - To evaluate the efficacy of paromomycin for the treatment of symptomatic cryptosporidial enteritis in human immunodeficiency virus-infected adults, we conducted a prospective, randomized, double-blind, placebo-controlled trial before the widespread introduction of highly active antiretroviral therapy (HAART). Seven units under the auspices of the AIDS Clinical Trials Group enrolled 35 adults with CD4 cell counts of ≤150/mm3. Initially, 17 patients received paromomycin (500 mg 4 times daily) and 18 received matching placebo for 21 days. Then all patients received paromomycin (500 mg q.i.d.) for an additional 21 days. Clinical definitions of response were measured by an average number of bowel movements per day in association with concurrent need for antidiarrheal agents that was lower than that before study entry. There was no treatment response during the placebo-controlled phase of the study according to protocol-defined criteria (P = .88). Three paromomycin recipients (17.6%) versus 2 placebo recipients (14.3%) responded completely. Rates of combined partial and complete responses in the paromomycin arm (8 out of 17, 47.1%) and the placebo arm (5 out of 14, 35.7%) of the study were also similar (P = .72). The clinical course of cryptosporidiosis was quite variable. Paromomycin was not shown to be more effective than placebo for the treatment of symptomatic cryptosporidial enteritis. However, inadequate statistical power prevents definitive rejection of the usefulness of paromomycin as therapy for this infection.

UR - http://www.scopus.com/inward/record.url?scp=0034451315&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0034451315&partnerID=8YFLogxK

U2 - 10.1086/318155

DO - 10.1086/318155

M3 - Article

C2 - 11049793

AN - SCOPUS:0034451315

VL - 31

SP - 1084

EP - 1092

JO - Clinical Infectious Diseases

JF - Clinical Infectious Diseases

SN - 1058-4838

IS - 4

ER -