Empiric deworming to delay HIV disease progression in adults with HIV who are ineligible for initiation of antiretroviral treatment (the HEAT study): a multi-site, randomised trial.

BACKGROUND: Co-infection with HIV and helminths is common in sub-Saharan Africa and findings from previous studies have suggested that anthelmintic treatment might delay immunosuppression in people with HIV. We aimed to assess the efficacy of empiric deworming of adults with HIV in delaying HIV disease progression. METHODS: In this non-blinded randomised trial, we enrolled adults (aged ≥18 years) with HIV who did not meet criteria for the initiation of antiretroviral treatment from three sites in Kenya. Using a computer-generated sequence, we randomly assigned (1:1) eligible participants to either empiric albendazole every 3 months plus praziquantel annually (treatment group) or to standard care (control group). Participants were followed up for 24 months. We measured CD4 cell counts every 6 months and plasma HIV RNA annually. The primary endpoints were a CD4 count of less than 350 cells per μL and a composite endpoint consisting of the first occurrence of a CD4 count of less than 350 cells per μL, first reported use of antiretroviral treatment, and non-traumatic deaths. We compared these measures by use of Cox proportional hazards regression and Kaplan-Meier survival analyses. Primary analysis was done by intention to treat. The trial was registered with ClinicalTrials.gov, number NCT0050722. FINDINGS: Between Feb 6, 2008, and June 21, 2011, we enrolled and followed-up 948 participants; 469 were allocated to the treatment group and 479 to the control group. All participants were provided with co-trimoxazole prophylaxis. Median baseline CD4 cell counts and HIV RNA concentrations did not differ between groups. We recorded no statistically significant difference between the treatment and control groups in the number of people reaching a CD4 count of fewer than 350 cells per μL (41·6 events per 100 person-years vs 46·2 events per 100 person-years; hazard ratio 0·89, 95% CI 0·75-1·06, p=0·2) or the composite endpoint (44·0 events per 100 person-years vs 49·8 events per 100 person-years; 0·88, 0·74-1·04, p=0·1). Serious adverse events, none of which thought to be treatment-related, occurred at a similar frequency in both groups. INTERPRETATION: Our findings do not suggest an effect of empiric deworming in the delaying of HIV disease progression in adults with HIV in an area where helminth infection is common. Alternative approaches are needed to delay HIV disease progression in areas where co-infections are common