Reduction of EArly mortaLITY in HIV-infected Adults and Children Starting Antiretroviral Therapy
Reduction of EArly mortaLITY in HIV-infected Adults and Children Starting Antiretroviral Therapy
NCT ID: NCT01825031 Phase: PHASE3 Status: COMPLETED Enrollment: 1805 Completion: 2016-03
Conditions
Human Immunodeficiency Virus
Interventions
Raltegravir, Fluconazole, Azithromycin, Albendazole, Isoniazid, Ready to Use Supplementary Food
Summary
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.
Primary Outcome
All-cause mortality over the first 24 weeks after starting ART