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REALITY
Reduction of EArly mortaLITY in HIV-infected adults and children starting antiretroviral therapy
Can early mortality in those starting ART with severe immunodeficiency be reduced?
What is this study about?

A randomised controlled trial to investigate three methods to reduce early mortality in adults, adolescents and children aged 5 years or older starting antiretroviral therapy (ART) with severe immuno-deficiency. The three methods are:

  1. increasing the potency of ART with a 12 week induction period using 4 antiretroviral (ARV) drugs from 3 classes (rather than standard 3 ARVs from 2 classes)
  2. augmented prophylaxis against opportunistic/bacterial infections and helminths for 12 weeks
  3. macronutrient intervention using ready-to-use supplementary food for 12 weeks.

Who is included?

1800 HIV-infected patients including adults, adolescents and children aged 5 years or older with low CD4 counts (<100 cells/mm3) about to initiate combination antiretroviral therapy (ART). 400 to 600 children aged 5-12 years and at least 1200 adolescents and adults aged 13+ years.

Contact details

When is it taking place?

Recruitment began in June 2013 and completed in April 2015. The last patient last visit was in March 2016.

Where is it taking place?

  • Joint Clinical Research Centre (JCRC), Kampala, Uganda (Coordinating centre only – not recruiting patients)
  • JCRC Fort Portal, Uganda
  • JCRC Mbarara, Uganda
  • JCRC Mbale, Uganda
  • JCRC Gulu, Uganda
  • University of Zimbabwe Clinical Research Centre (UZCRC), Harare, Zimbabwe
  • University of Malawi, Department of Medicine, Blantyre, Malawi
  • Moi University Clinical Research Centre (MUCRC), Eldoret, Kenya
  • KEMRI Wellcome Trust Centre, Kilifi, Kenya

Who is funding the study?

Department for International Development, UK (DFID), the Wellcome Trust and the Medical Research Council (MRC) UK. Additional funding support is provided by the PENTA foundation.

Further information


Type of study:
Randomised trial
Status:
Closed
Study start date:
18 June 2013

Related Publications

Post, F.A., Szubert, A.J., Prendergast, A.J., Johnston, V., Lyall, H., Fitzgerald, F., Musiime, V., Musoro, G., Chepkorir, P., Agutu, C., Mallewa, J., Rajapakse, C., Wilkes, H., Hakim, J., Mugyenyi, P., Walker, A.S., Gibb, D.M., Pett, S.L., for the Reduction of EArly mortaLITY in HIV-infected adults and children starting antiretroviral therapy (REALITY) Trial Tea.

Causes and timing of mortality and morbidity among late presenters starting antiretroviral therapy in the REALITY trial. Clinical Infectious Diseases. 2018; 66:S132-S139

Siika, A., McCabe, L., Bwakura-Dangarembizi, M., Kityo, C., Mallewa, J., Berkley, J., Maitland, K., Griffiths, A., Baleeta, K., Mudzingwa, S., Abach, J., Nathoo, K., Thomason, M.J., Prendergast, A.J., Walker, A S., Gibb, D M., for the Reality Trial Tea.

Late presentation with HIV in Africa: phenotypes, risk, and risk stratification in the REALITY trial. Clinical Infectious Diseases. 2018; 66:S140-S146

Mallewa, J., Szubert, A.J., Mugyenyi, P., Chidziva, E., Thomason, M.J., Chepkorir, P., Abongomera, G., Baleeta, K., Etyang, A., Warambwa, C., Melly, B., Mudzingwa, S., Kelly, C., Agutu, C., Wilkes, H., Nkomani, S., Musiime, V., Lugemwa, A., Pett, S.L., Bwakura-Dangarembizi, M., Prendergast, A.J., Gibb, D.M., Walker, A.S., Berkley, J.A., on behalf of the Reality trial tea.

Effect of ready-to-use supplementary food on mortality in severely immunocompromised HIV-infected individuals in Africa initiating antiretroviral therapy (REALITY): an open-label, parallel-group, randomised controlled trial. Lancet HIV. 2018; 5:e231-e240

Phillips, A.N., Munderi, P., Revill, P.A., El-Sadr, W.M., Lundgren, J.

Antiretroviral therapy recommendations for the global community: aspiration versus reality. AIDS. 2014; 28:939-941

Ma, Z., Lienhardt, C., McIlleron, H., Nunn, A.J., Wang, .

Global tuberculosis drug development pipeline: the need and the reality. Lancet. 2010; 375:2100-2109