Nitazoxanide for persistent diarrhoea in Zambian acquired immune deficiency syndrome patients

a randomized-controlled trial

ZULU, I.
KELLY, P.
NJOBVU, L.
SIANONGO, S.
KAONGA, K.
MCDONALD, V.
FARTHING, M.
POLLOK, R.

*Department of Medicine and Pathology, University of Zambia School of Medicine, Lusaka, Zambia
†Centre for Adult and Paediatric Gastroenterology, ICMS, Bart's & The London, Queen Mary's School of Medicine, London, UK
‡St George's Hospital Medical School, London, UK

Correspondence to: Dr I. Zulu, Department of Medicine, University Teaching Hospital, PO Box 50110, Lusaka, Zambia. E-mail: [email protected]

Accepted for publication 30 December 2004

Alimentary Pharmacology & Therapeutics 21(6):p 757-763, March 2005.

Summary

Background

Adults with acquired immune deficiency syndrome and persistent diarrhoea in Zambia have intestinal infection, predominantly protozoa.

Aim

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/μL 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.