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Reduction of Early mortALITY in HIV-infected African Adults and Children Starting Antiretroviral Therapy: a Randomised Controlled Trial (REALITY)
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: (i) increasing the potency of ART with a 12 week induction period using 4 antiretroviral drugs from 3 classes (ii) augmented prophylaxis against opportunistic/bacterial infections and helminths for 12 weeks (iii) macronutrient intervention using ready-to-use supplementary food for 12 weeks.
Details
| Lead sponsor | Anna Griffiths, MRC |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 1805 |
| Start date | 2013-06 |
| Completion | 2016-03 |
Conditions
- Human Immunodeficiency Virus
Interventions
- Raltegravir
- Fluconazole
- Azithromycin
- Albendazole
- Isoniazid
- Ready to Use Supplementary Food
Primary outcomes
- All-cause mortality over the first 24 weeks after starting ART — Week 24
Countries
Kenya, Malawi, Uganda, Zimbabwe