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

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.

Conditions

• Human Immunodeficiency Virus

Interventions

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

Sponsors & Collaborators

• Department for International Development, United Kingdom

  collaborator OTHER_GOV

• Wellcome Trust

  collaborator OTHER

• Medical Research Council

  collaborator OTHER_GOV

• PENTA Foundation

  collaborator NETWORK

• Anna Griffiths, MRC

  lead OTHER_GOV

Principal Investigators

• Diana M Gibb · Medical Research Council

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

FACTORIAL

Eligibility

Min Age

5 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-06-30

Primary Completion

2016-03-31

Completion

2016-03-31

Countries

• Kenya
• Malawi
• Uganda
• Zimbabwe

Study Locations