Nitazoxanide for persistent diarrhoea in Zambian acquired immune deficiency syndrome patients: a randomized-controlled trial.
BACKGROUND
Adults with acquired immune deficiency syndrome and persistent diarrhoea in Zambia have intestinal infection, predominantly protozoa.


OBJECTIVE
To search for treatment which can be offered with minimal investigation, we carried out a double-blind, randomized-controlled trial of nitazoxanide (a drug with a range of activity against parasites and bacteria).


METHODS
Patients with diarrhoea of 1 month duration or longer were randomized to receive nitazoxanide (1000 mg twice daily) or placebo for 2 weeks. End-points were clinical response, parasitological clearance and mortality.


RESULTS
Two hundred and seven adults were randomized; 42 died during the study. The primary assessment of efficacy was made after 17 days. Clinical response was observed in 56 (75%) of 75 patients receiving nitazoxanide and 45 (58%) of 77 patients receiving placebo (P = 0.03). The rate of improvement was markedly higher in patients with CD4 counts under 50 cells/microL receiving nitazoxanide (P = 0.007). The benefit was largely restricted to the period when the drug was being administered. No difference was seen in parasitological clearance between the two groups. Mortality was 19% by 4 weeks of follow-up and did not differ with treatment allocation.


CONCLUSIONS
Nitazoxanide given orally for 14 days was associated with clinical improvement in Zambian acquired immune deficiency syndrome patients with diarrhoea, especially those with very low CD4 counts.
Zulu
I
I
Department of Medicine and Pathology, University of Zambia School of Medicine, Lusaka, Zambia. zuluisaac@yahoo.com
Kelly
P
P
Njobvu
L
L
Sianongo
S
S
Kaonga
K
K
McDonald
V
V
Farthing
M
M
Pollok
R
R
D000163:Acquired Immunodeficiency Syndrome / Q000150:complications*; D000284:Administration, Oral; D000328:Adult; D000977:Antiparasitic Agents / Q000008:administration & dosage*; D001424:Bacterial Infections / Q000188:drug therapy; D018791:CD4 Lymphocyte Count; D002908:Chronic Disease; D003967:Diarrhea / Q000150:complications / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007411:Intestinal Diseases, Parasitic / Q000188:drug therapy; D008297:Male; D009574:Nitro Compounds; D013844:Thiazoles / Q000008:administration & dosage*
D000977:Antiparasitic Agents; D009574:Nitro Compounds; D013844:Thiazoles; C041747:nitazoxanide