AEGiS-04CROI: A phase II dose escalation trial of high dose fluconazole with and without flucytosine for AIDS associated cryptococcal meningitis.

4th Conference on Retroviruses and Opportunistic Infections


Washington, DC - January 22-26, 1997

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A phase II dose escalation trial of high dose fluconazole with and without flucytosine for AIDS associated cryptococcal meningitis.

Conf Retroviruses Opportunistic Infect 1997 Jan 22-26; 4th:65 (abstract no. 5)

Milefchik E, Leal M, Haubrich R, Bozzette S, Tilles J, Leedom J, McCutchan JA, Larsen RA; Los Angeles, CA.

Objective: To determine if higher doses of fluconazole with and without flucytosine (5-FC) could be used safely and effectively.

Methods: Eighty-nine patients with their first episode of AIDS associated cryptococcal meningitis were enrolled at three University Hospitals. A successful outcome was defined as survival to ten weeks coupled with a negative cerebrospinal fluid culture obtained at or prior to ten weeks.

Results: There was a significant increase in efficacy among patients receiving fluconazole as doses increased. A successful outcome at ten weeks was observed in 11%, 37%, 62% and 62% of those that received 800, 1200, 1600 and 2000 mg/d of fluconazole, respectively (p is less than 0.01). When fluconazole was combined with 5-FC at 150 mg/kg.d for four weeks, there was an incremental response at each combination dose level with 75%, 87%, 69% and 83% successfully treated at fluconazole doses of 800, 1200, 1600 and 2000 mg/d, respectively (p is less than 0.01). Fluconazole was well tolerated at all dose levels.

Conclusions: Use of higher doses of fluconazole significantly improves clinical outcome in patients with cryptococcal meningitis especially when combined with flucytosine. All combination regimens were highly effective with the all oral regimen useful for those with limited hospital resources.

Keywords: AEGIS, Meningitis, Cryptococcal, Flucytosine, Fluconazole, Acquired Immunodeficiency Syndrome, Antifungal Agents, Clinical Trials, Antibiotics, Antifungal, Weights and Measures, Human, AIDSKWDaegis,meningitis,cryptococcal,flucytosine,fluconazole,acquiredimmunodeficiencysyndrome,antifungalagents,clinicaltrials,antibiotics,antifungal,weightsandmeasures,human,aids

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