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

Phase 3

Completed

• Conditions: Human Immunodeficiency Virus (HIV); Infections and Infestations; Human immunodeficiency virus [HIV] disease

• Registration Number: ISRCTN43622374
• Lead Sponsor: Medical Research Council (UK)

Brief Summary

2017 Results article in https://www.ncbi.nlm.nih.gov/pubmed/28723333 2018 Results article in https://www.ncbi.nlm.nih.gov/pubmed/29653915 2018 Results article in https://www.ncbi.nlm.nih.gov/pubmed/30513108 2018 Results article in https://www.ncbi.nlm.nih.gov/pubmed/29514234 (added 01/10/2019) 2018 Results article in https://www.ncbi.nlm.nih.gov/pubmed/29514235 (added 01/10/2019) 2020 Other publications in https://pubmed.ncbi.nlm.nih.gov/33336080/ Calprotectin as a biomarker (added 21/12/2020) 2024 Other publications in https://pubmed.ncbi.nlm.nih.gov/38944653/ Biomarkers of mortality (added 01/07/2024)

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10-18
• Study Completion: 2015-08-31
• Last Update Posted: 15 July 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 1805

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mortality over the first 24 weeks after starting anti-retroviral therapy

Secondary Outcome Measures

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