NCT01825031

Reduction of EArly mortaLITY in HIV-infected Adults and Children Starting Antiretroviral Therapy

Reduction of Early mortALITY in HIV-infected African Adults and Children Starting Antiretroviral Therapy: a Randomised Controlled Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,805 (actual)
• Sponsor: Anna Griffiths, MRC · Other Government
• Sex: All
• Age: 5 Years
• Healthy volunteers: Not accepted

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.

Detailed description

REALITY is a open-label randomised trial of 1800 adults, adolescents and children aged 5 years or more with low CD4 counts about to initiate ART. The trial will have a factorial design with 3 randomisations, each to address one of the potential approaches to reduce early mortality in adults and children initiating ART with low CD4, namely: 1. Raltegravir for 12 weeks from ART initiation in addition to 3 standard ART (3-drug 2-class) versus standard of care first-line 3-drug 2-class ART (choice according to national guidelines for ART initiation); 2. Immediate enhanced opportunistic infections (OI) prophylaxis with isoniazid/pyridoxine and cotrimoxazole, plus 12 weeks fluconazole, 5 days azithromycin and a single dose of albendazole versus cotrimoxazole prophylaxis alone for the first 12 weeks followed by isoniazid and any prophylaxis and/or treatment prescribed at screening 3. supplementation with Ready to Use Supplementary Food (RUSF) for 12 weeks versus standard of care nutritional support to those with poor nutritional status according to local guidelines. All participants will receive cotrimoxazole throughout the trial. The primary objective of the trial is to identify effective, safe and acceptable interventions to reduce early mortality (all-cause) in HIV-infected adults, adolescents, and older children (5 years or more) initiating ART.

Conditions

• Human Immunodeficiency Virus

Interventions

Type	Name	Description
DRUG	Raltegravir	400mg twice daily for the first 12 weeks only in addition to 3 standard ARVs
DRUG	Fluconazole	100mg once daily for 12 weeks
DRUG	Azithromycin	500mg once daily for 5 days
DRUG	Albendazole	a single dose 400mg
DRUG	Isoniazid	300mg taken immediately in combination with cotrimoxazole
DIETARY_SUPPLEMENT	Ready to Use Supplementary Food	2x92g packets daily of high energy, low protein lipid-based paste for 12 weeks

Timeline

• Start date: 2013-06-01
• Primary completion: 2016-03-01
• Completion: 2016-03-01
• First posted: 2013-04-05
• Last updated: 2016-04-20

Locations

8 sites across 4 countries: Kenya, Malawi, Uganda, Zimbabwe