Randomized, controlled study of the safety and efficacy of intravenous cidofovir for the treatment of relapsing cytomegalovirus retinitis in patients with AIDS

Jacob P. Lalezari, Gary N. Holland, Françoise Kramer, George F. McKinley, Carol A. Kemper, David V. Ives, Robert Nelson, W. David Hardy, Baruch D. Kuppermann, Donald W. Northfelt, Michael Youle, Margaret Johnson, Richard Alan Lewis, David V. Weinberg, Gary L. Simon, Richard A. Wolitz, April E. Ruby, Robert J. Stagg, Howard S. Jaffe

Research output: Contribution to journalArticle

86 Citations (Scopus)

Abstract

To assess the effect of intravenous cidofovir on delaying progression of previously treated, relapsing cytomegalovirus (CMV) retinitis, we conducted a randomized, controlled comparison of two maintenance dose levels of cidofovir. One hundred and fifty patients with AIDS and CMV retinitis that had progressed or was persistently active despite treatment with ganciclovir, foscarnet, or both were randomized to receive induction cidofovir, 5 mg/kg once weekly for 2 weeks, then maintenance therapy with either 5 mg/kg or 3 mg/kg once every other week. Concomitant probenecid and intravenous hydration were administered with each cidofovir dose. Retinitis progression was assessed in the first 100 patients by bilateral, full-field retinal photographs read at a central reading center by an ophthalmologist masked to treatment assignment. Incidence of side effects, changes in visual acuity, and mortality were also assessed. Median time to retinitis progression as assessed by retinal photography was not reached (95% confidence interval [CI], 115 days-upper limit not reached) in the 5-mg/kg group, and was 49 days (95% CI, 35-52 days) in the 3-mg/kg group (p = .0006). Dose-dependent asymptomatic proteinuria (39%) and serum creatinine elevation (24%) were the most common adverse events thought to be related to cidofovir. Reversible probenecid reactions including constitutional symptoms and nausea occurred in 65 of 150 (43%) patients. Cidofovir therapy is effective in delaying progression of CMV retinitis that had previously progressed using other anti- CMV therapies.

Original languageEnglish (US)
Pages (from-to)339-344
Number of pages6
JournalJournal of Acquired Immune Deficiency Syndromes and Human Retrovirology
Volume17
Issue number4
StatePublished - Apr 1 1998
Externally publishedYes

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Cytomegalovirus Retinitis
Acquired Immunodeficiency Syndrome
Safety
Retinitis
Probenecid
Therapeutics
Confidence Intervals
Foscarnet
Ganciclovir
Photography
Cytomegalovirus
Proteinuria
Nausea
Visual Acuity
cidofovir
Reading
Creatinine
Mortality
Incidence
Serum

Keywords

  • AIDS
  • Cidofovir
  • CMV retinitis

ASJC Scopus subject areas

  • Immunology and Allergy
  • Immunology
  • Virology

Cite this

Randomized, controlled study of the safety and efficacy of intravenous cidofovir for the treatment of relapsing cytomegalovirus retinitis in patients with AIDS. / Lalezari, Jacob P.; Holland, Gary N.; Kramer, Françoise; McKinley, George F.; Kemper, Carol A.; Ives, David V.; Nelson, Robert; David Hardy, W.; Kuppermann, Baruch D.; Northfelt, Donald W.; Youle, Michael; Johnson, Margaret; Lewis, Richard Alan; Weinberg, David V.; Simon, Gary L.; Wolitz, Richard A.; Ruby, April E.; Stagg, Robert J.; Jaffe, Howard S.

In: Journal of Acquired Immune Deficiency Syndromes and Human Retrovirology, Vol. 17, No. 4, 01.04.1998, p. 339-344.

Research output: Contribution to journalArticle

Lalezari, JP, Holland, GN, Kramer, F, McKinley, GF, Kemper, CA, Ives, DV, Nelson, R, David Hardy, W, Kuppermann, BD, Northfelt, DW, Youle, M, Johnson, M, Lewis, RA, Weinberg, DV, Simon, GL, Wolitz, RA, Ruby, AE, Stagg, RJ & Jaffe, HS 1998, 'Randomized, controlled study of the safety and efficacy of intravenous cidofovir for the treatment of relapsing cytomegalovirus retinitis in patients with AIDS', Journal of Acquired Immune Deficiency Syndromes and Human Retrovirology, vol. 17, no. 4, pp. 339-344.
Lalezari, Jacob P. ; Holland, Gary N. ; Kramer, Françoise ; McKinley, George F. ; Kemper, Carol A. ; Ives, David V. ; Nelson, Robert ; David Hardy, W. ; Kuppermann, Baruch D. ; Northfelt, Donald W. ; Youle, Michael ; Johnson, Margaret ; Lewis, Richard Alan ; Weinberg, David V. ; Simon, Gary L. ; Wolitz, Richard A. ; Ruby, April E. ; Stagg, Robert J. ; Jaffe, Howard S. / Randomized, controlled study of the safety and efficacy of intravenous cidofovir for the treatment of relapsing cytomegalovirus retinitis in patients with AIDS. In: Journal of Acquired Immune Deficiency Syndromes and Human Retrovirology. 1998 ; Vol. 17, No. 4. pp. 339-344.
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