Objective: To determine the value of short course, high dose albendazole chemotherapy in the treatment of persistent diarrhoea related to HIV in unselected patients in urban Zambia.
Design: A randomised double blind placebo controlled trial of albendazole 800 mg twice daily for two weeks. Patients were monitored intensively for one month and followed for up to six months.
Setting: Home care. AIDS services in Lusaka and Ndola.
Patients: 174 HIV seropositive patients with persistent diarrhoea (defined as loose but not bloody stools three or more times a day for three weeks or longer). No investigations were undertaken except HIV testing after counselling.
Main outcome measures: Proportion of time periods during which diarrhoea was experienced after completion of treatment; proportion of patients with full remission after completion of treatment; mortality.
Results: The patients taking albendazole had diarrhoea on 29% fewer days than those taking placebo (P < 0.0001) in the two weeks after treatment. The benefit of albendazole was maintained over six months. In patients with a Karnofsky score of 50 to 70 (needing help with activities of daily living and unable to work, but not needing admission to hospital) diarrhoea was reduced by 50%. Remission was obtained in 26% of all patients who received albendazole (P = 0.004 against 9% receiving placebo), and this difference was maintained over six months (log rank test, P = 0.003). Albendazole had no effect on mortality. Minimal adverse effects were noted.
Conclusions: For HIV infected Zambians with diarrhoea of more than three weeks' duration albendazole offers substantial relief from symptoms and may be used empirically, without prior investigation.
PIP: A randomized double blind placebo controlled trial was conducted in Zambia at the home care service of the University Teaching Hospital in Lusaka, the Ndola Central Hospital in the north, and the Kara HIV Counselling and Testing Project in central Lusaka to determine the extent albendazole can treat or suppress diarrhea in AIDS patients. The trial also aimed to identify a chemotherapeutic agent that could achieve diarrhea treatment or suppression and be administered in the community without prior investigation. Clinical researchers randomly allocated 174 HIV-positive patients with persistent diarrhea (i.e., loose but not bloody stools at least 3 times/day) to the group that received 800 mg albendazole twice daily for 2 weeks or the placebo group. They followed the patients for 6 months. The albendazole group had diarrhea less often than the placebo group for the entire 6 month period. The difference was significant at all time points (p 0.025) except at 5-8 weeks. At 3-4 weeks post-treatment, the reduction in diarrhea was significant among patients at the Kara Trust (31% reduction; p = 0.004) and in Ndola (41% reduction; p 0.0001) but not at the University Teaching Hospital (10% reduction). Two weeks after treatment, the albendazole group had diarrhea on 29% fewer days than the placebo group (p 0.0001). During the post-treatment weeks of 9-16, the albendazole group experienced diarrhea on 42% fewer days than the placebo group (p = 0.002). Throughout the entire 6-month period, patients in the albendazole group were more likely to achieve remission of diarrhea than the placebo group (e.g., 26% vs. 9%, p = 0.003). The proportion of patients who were in remission increased to 35% when the researchers excluded deaths and withdrawals from treatment. Patients who had a Karnofsky score (a measure of overall severity of illness at the time of entry into the study) of 50-70 benefitted the most from albendazole treatment for diarrhea. Albendazole had no significant effect on mortality. The researchers surmised that much of albendazole's effectiveness was due to its effect on microsporidia infections.