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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
- Source :
- The Lancet. HIV, E240, E231
- Publication Year :
- 2018
- Publisher :
- Elsevier B.V, 2018.
-
Abstract
- Funding: Joint Global Health Trials Scheme (UK Medical Research Council, UK Department for International Development, and Wellcome Trust). BACKGROUND: In sub-Saharan Africa, severely immunocompromised HIV-infected individuals have a high risk of mortality during the first few months after starting antiretroviral therapy (ART). We hypothesise that universally providing ready-to-use supplementary food (RUSF) would increase early weight gain, thereby reducing early mortality compared with current guidelines recommending ready-to-use therapeutic food (RUTF) for severely malnourished individuals only. METHODS: We did a 2 × 2 × 2 factorial, open-label, parallel-group trial at inpatient and outpatient facilities in eight urban or periurban regional hospitals in Kenya, Malawi, Uganda, and Zimbabwe. Eligible participants were ART-naive adults and children aged at least 5 years with confirmed HIV infection and a CD4 cell count of fewer than 100 cells per μL, who were initiating ART at the facilities. We randomly assigned participants (1:1) to initiate ART either with (RUSF) or without (no-RUSF) 12 weeks' of peanut-based RUSF containing 1000 kcal per day and micronutrients, given as two 92 g packets per day for adults and one packet (500 kcal per day) for children aged 5-12 years, regardless of nutritional status. In both groups, individuals received supplementation with RUTF only when severely malnourished (ie, body-mass index [BMI] 0·7). Through 48 weeks, adults and adolescents aged 13 years and older in the RUSF group had significantly greater gains in weight, BMI, and MUAC than the no-RUSF group (p=0·004, 0·004, and 0·03, respectively). The most common type of serious adverse event was specific infections, occurring in 90 (10%) of 897 participants assigned RUSF and 87 (10%) of 908 assigned no-RUSF. By week 48, 205 participants had serious adverse events in both groups (p=0·81), and 181 had grade 4 adverse events in the RUSF group compared with 172 in the non-RUSF group (p=0·45). INTERPRETATION: In severely immunocompromised HIV-infected individuals, providing RUSF universally at ART initiation, compared with providing RUTF to severely malnourished individuals only, improved short-term weight gain but not mortality. A change in policy to provide nutritional supplementation to all severely immunocompromised HIV-infected individuals starting ART is therefore not warranted at present. Publisher PDF Publisher PDF
- Subjects :
- IMMUNE-ACTIVATION
Adult
Male
RZ Other systems of medicine
Adolescent
Arachis
Immunology
NDAS
HIV Infections
Article
Body Mass Index
INSECURITY
EFAVIRENZ
Young Adult
SDG 3 - Good Health and Well-being
Anti-Infective Agents
RA0421
RZ
RA0421 Public health. Hygiene. Preventive Medicine
Raltegravir Potassium
Humans
Micronutrients
SDG 2 - Zero Hunger
Child
Africa South of the Sahara
Aged
RISK
OUTCOMES
Science & Technology
Body Weight
ADULTS
ASSOCIATION
Middle Aged
Survival Analysis
Infectious Diseases
Treatment Outcome
Anti-Retroviral Agents
Child, Preschool
HIV/AIDS
Female
Life Sciences & Biomedicine
REALITY trial team
Diet Therapy
Subjects
Details
- Language :
- English
- ISSN :
- 23523018 and 24054704
- Volume :
- 5
- Issue :
- 5
- Database :
- OpenAIRE
- Journal :
- The Lancet. HIV
- Accession number :
- edsair.pmid.dedup....6241fdee11cfcf8d04e48e713356844b