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Adjunctive Dexamethasone in HIV-Associated Cryptococcal Meningitis.

Justin Beardsley1, Marcel Wolbers, Freddie M Kibengo

  • 1From the Oxford University Clinical Research Unit, Wellcome Trust Major Overseas Programme Vietnam (J.B., M.W., J.F., L.M., G.T., J.N.D.), Hospital for Tropical Diseases (N.T.K.C., N.V.V.C.), Cho Ray Hospital (T.Q.B., L.P.), Ho Chi Minh City, and the National Hospital for Tropical Diseases (N.V.K.) and Bach Mai Hospital (P.T.T.), Hanoi - all in Vietnam; Nuffield Department of Clinical Medicine, Centre for Tropical Medicine and Global Health, University of Oxford, Oxford (J.B., M.W., J.F., L.M., G.T., M.M., D.D., J.N.D.), University College London, London (R.H.), and Liverpool School of Tropical Medicine, Liverpool (D.G.L.) - all in the United Kingdom; MRC/UVRI Uganda Research Unit on AIDS, Entebbe, Uganda (F.M.K., A.-B.M.G., A.K.); Mahidol Oxford Tropical Medicine Research Unit, Mahidol University, Bangkok (W.C.), Ubon Sappasithiprasong Hospital, Ubon (S.S., W.S.), and Udon Thani Hospital, Udon Thani (E.T., S.O.) - all in Thailand; Dignitas International, Zomba (A.K.C., E.M., J.J.O.), and Malawi-Liverpool-Wellcome Trust, Clinical Research Programme (R.H., D.G.L.), and University of Malawi College of Medicine (R.H., J.J.O.), Blantyre - all in Malawi; Sunnybrook Health Sciences Centre, University of Toronto, Toronto (A.K.C.); Cipto Mangunkusumo Hospital (D.I.) and Eijkman Oxford Clinical Research Unit (H.B.) - both in Jakarta, Indonesia; and Lao-Oxford-Mahosot Hospital-Wellcome Trust Research Unit, Mahosot Hospital (M.M., D.D., P.P., S.R.), and University of Health Sciences (M.M.) - both in Vientiane, Laos.

The New England Journal of Medicine
|February 11, 2016
PubMed
Summary

Dexamethasone did not improve survival for cryptococcal meningitis in HIV patients. The drug increased adverse events and disability, showing no benefit over standard antifungal therapy.

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Area of Science:

  • Infectious Diseases
  • Clinical Trials
  • HIV/AIDS Research

Background:

  • Cryptococcal meningitis is a leading cause of death in HIV patients globally, with limited treatment advancements.
  • Current treatment protocols for cryptococcal meningitis have remained unchanged for two decades.
  • The efficacy of adjuvant glucocorticoids, like dexamethasone, in treating cryptococcal meningitis is unknown.

Purpose of the Study:

  • To evaluate the effectiveness of dexamethasone as an adjuvant therapy for HIV-associated cryptococcal meningitis.
  • To assess the impact of dexamethasone on mortality and clinical outcomes in patients with cryptococcal meningitis.

Main Methods:

  • A double-blind, randomized, placebo-controlled trial involving 451 adult patients with HIV-associated cryptococcal meningitis across multiple countries.
  • Patients received either dexamethasone or a placebo for six weeks, combined with standard antifungal treatment (amphotericin B and fluconazole).

Main Results:

  • The trial was halted early due to safety concerns. Mortality rates were higher in the dexamethasone group (47% at 10 weeks, 57% at 6 months) compared to the placebo group (41% and 49%, respectively).
  • Dexamethasone use was associated with increased disability (13% vs. 25% good outcome), more clinical adverse events (667 vs. 494), and higher rates of severe infections, renal, and cardiac events.
  • Slower fungal clearance in cerebrospinal fluid was observed in the dexamethasone group.

Conclusions:

  • Dexamethasone does not reduce mortality in HIV-associated cryptococcal meningitis.
  • Adjuvant dexamethasone therapy is linked to increased adverse events and disability in this patient population.
  • The findings do not support the use of dexamethasone in the treatment of HIV-associated cryptococcal meningitis.