Reduction of early mortality in HIV-infected African adults and children starting antiretroviral therapy

Conditions

Human Immunodeficiency Virus (HIV) Infections and Infestations Human immunodeficiency virus [HIV] disease

Victor Riitho, Roisin Connon, Agnes Gwela, Josephine Namusanje, R Nhema et al. (14 authors)

Nature Communications2024-06-2810 citations

10.1038/s41467-024-49317-7

Plasma calprotectin as a biomarker of mortality at antiretroviral treatment initiation in advanced HIV - pilot study.

Kamau FW, Gwela A, Nyerere AK, Riitho V, Njunge JM, Ngari MM, Prendergast AJ, Berkley JA.

2020-11-27

10.12688/wellcomeopenres.15563.2

Raltegravir-intensified initial antiretroviral therapy in advanced HIV disease in Africa: A randomised controlled trial.

Kityo C, Szubert AJ, Siika A, Heyderman R, Bwakura-Dangarembizi M, Lugemwa A, Mwaringa S, Griffiths A, Nkanya I, Kabahenda S, Wachira S, Musoro G, Rajapakse C, Etyang T, Abach J, Spyer MJ, Wavamunno P, Nyondo-Mipando L, Chidziva E, Nathoo K, Klein N, Hakim J, Gibb DM, Walker AS, Pett SL, REALITY trial team.

2018-12-0429 citations

10.1371/journal.pmed.1002706

Late Presentation With HIV in Africa: Phenotypes, Risk, and Risk Stratification in the REALITY Trial

Abraham Siika, Leanne McCabe, Mutsa Bwakura‐Dangarembizi, Cissy Kityo, Jane Mallewa et al. (100 authors)

Clinical Infectious Diseases2018-01-0334 citations

10.1093/cid/cix1142

Causes and Timing of Mortality and Morbidity Among Late Presenters Starting Antiretroviral Therapy in the REALITY Trial

Frank A. Post, Alexander J. Szubert, Andrew J. Prendergast, Victoria Johnston, Hermione Lyall et al. (72 authors)

Clinical Infectious Diseases2018-01-0240 citations

10.1093/cid/cix1141

Enhanced Prophylaxis plus Antiretroviral Therapy for Advanced HIV Infection in Africa

James Hakim, Victor Musiime, Alex J. Szubert, Jane Mallewa, Abraham Siika et al. (23 authors)

New England Journal of Medicine2017-07-19213 citations

10.1056/nejmoa1615822

Evaluation of a point-of-care tuberculosis test-and-treat algorithm on early mortality in people with HIV accessing antiretroviral therapy (TB Fast Track study): study protocol for a cluster randomised controlled trial

Katherine Fielding, Salome Charalambous, Christopher J. Hoffmann, Suzanne M. Johnson, Mpho Tlali et al. (9 authors)

Trials2015-03-2714 citations

10.1186/s13063-015-0650-0

Interventions

Three methods to reduce early mortality following antiretroviral therapy (ART) initiation: 1. Increasing the potency of ART with a 12 week induction period using 4 antiretroviral drugs from 3 classes

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged 5 years or older (the lower age limit is because CD4 counts are less reliable predictors of immunodeficiency under 5 years: CD4 counts are recommended by WHO guidelines in older children) 2. Documented HIV infection by HIV ELISA 3. Naive to ART except for drugs given or received to prevent mother-to-child transmission 4. CD4 T-cell count <100 cells/mm3 on blood test taken at screening for REALITY 5. Results of screening haematology and biochemistry tests available 6. Patient/carer provide informed consent (and children <18 years assent, as appropriate according to their age and knowledge of HIV status)

Exclusion criteria

Exclusion criteria: 1. Contraindications to any proposed antiretroviral drugs (including integrase inhibitors), isoniazid, fluconazole, albendazole or azithromycin 2. Pregnant or breastfeeding or intending to become pregnant during the first 12 weeks of the study

Design outcomes

Primary

Measure	Time frame
Mortality over the first 24 weeks after starting anti-retroviral therapy	—

Secondary

Measure	Time frame
1. Mortality in 48 weeks after starting anti-retroviral therapy 2. Safety: 2.1. Serious adverse events 2.2. Grade 4 adverse events 2.3. Adverse events leading to modification of ART or other study drugs 3. Endpoints relating to the specific mechanisms of action of each intervention 3.1. Anti-HIV: CD4 levels 3.2. Anti-infection: incidence of tuberculosis, cryptococcal and candida disease, severe bacterial infections 3.3. Nutritional: body mass index (BMI), weight and body fat assessed by bioimpedance analysis (BIA), height (in children), grip strength 4. Hospital inpatient episodes and total days admitted 5. Adherence to ART and acceptability of each strategy measured by pill counts and questionnaire	—

Measure

Time frame

1. Mortality in 48 weeks after starting anti-retroviral therapy 2. Safety: 2.1. Serious adverse events 2.2. Grade 4 adverse events 2.3. Adverse events leading to modification of ART or other study drugs 3. Endpoints relating to the specific mechanisms of action of each intervention 3.1. Anti-HIV: CD4 levels 3.2. Anti-infection: incidence of tuberculosis, cryptococcal and candida disease, severe bacterial infections 3.3. Nutritional: body mass index (BMI), weight and body fat assessed by bioimpedance analysis (BIA), height (in children), grip strength 4. Hospital inpatient episodes and total days admitted 5. Adherence to ART and acceptability of each strategy measured by pill counts and questionnaire

—

Countries

Kenya, Malawi, Uganda, Zimbabwe

Outcome results

None listed