AEGiS-04CROI: A double-blind, placebo-controlled trial of paromomycin (par) for the treatment of cryptosporidiosis (cs) in patients with advanced HIV disease and CD4 counts under 150 (ACTG 192).

4th Conference on Retroviruses and Opportunistic Infections

Washington, DC - January 22-26, 1997

A double-blind, placebo-controlled trial of paromomycin (par) for the treatment of cryptosporidiosis (cs) in patients with advanced HIV disease and CD4 counts under 150 (ACTG 192).

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

Hewitt RG, Yiannoutsos CT, Carey J, Geiseler PJ, Soave R, Rosenberg R, Vazquez GJ, Wheat J, Fass RJ, Higgs ES, Antoninjevic Z, Walawander AL, Flanigan T, Bender J; University of Buffalo, Buffalo, NY.

Objective: To determine the clinical and antimicrobial efficacy of par for cryptosporidiosis in patients (pts) with advanced HIV Disease.

Methods: 35 pts were randomized in a double blind fashion to receive par 500mg QID for 21 days or placebo (pla). After 21 days, all pts received open label par 500mg QID for 21 days. Pts without a complete response could then receive 1000mg QID for an additional 21 days. Pts with a partial or complete response after 9 wks were offered an optional 16 week maintenance period. Definitions of response and failure were developed utilizing bowel movement frequency and antidiarrheal pill use. Stool oocysts, weight, and symptoms were documented.

Results: 17 pts received par and 18 pts received pla. The mean CD4 cell count at entry was 38 cells/mm³. 31 (89%) completed the initial 21 days (wks 1-3); 29 (83%) completed the open-label period (wks 4-6). At week 3, 18 (58.1%) failed (9 (52.9%) par, 9 (64.3%) pla), 8 (25.8%) achieved partial response (5 (29.4%) par, 3 (21.4%) pla) and 5 (16.1%) achieved complete response (3 (17.6%) par, 2 (14.3%) pla) (P=0.884). There were no significant differences in change from baseline in diarrhea, anti-diarrheal pill use, weight, number of oocysts or other gastrointestinal symptoms. Similar results occurred at week 6 (P=1.000). 10 patients died (6 (35.3%) par, 4 (22.2%) pla) (P=0.47) due to complications of CS. The time to death was not different (P=0.56). One par patient died at week 3, the remaining pts died between weeks 10 to 20.

Conclusions: Treatment of cryptosporidiosis in patients with advanced HIV disease with paromomycin results in no clinical benefit. The variable nature of the illness is such that some patients improve without intervention.

Keywords: AEGIS, CD4 Lymphocyte Count, Paromomycin, HIV Infections, Cryptosporidiosis, Double-Blind Method, Placebos, Anti-HIV Agents, Reverse Transcriptase Inhibitors, Single-Blind Method, Drug Therapy, Combination, HIV Protease Inhibitors, Diarrhea, Animal, Human, therapy, drug therapy, AIDS

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