Safety and Metabolic Study of Highly Active Antiretroviral Therapy (HAART) in Malnourished Children With HIV

It is unclear whether children with HIV and severe acute malnutrition can be started on highly active antiretroviral therapy (HAART) safely while they are still malnourished and the manner in which this therapy should start. This study will examine the safety, efficacy, and metabolism of children started on HAART while still severely malnourished.

Completed

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Key information

Conditions

Kwashiorkor Deficiency Diseases HIV Malnutrition Marasmus Nutrition Disorders Nutritional and Metabolic Diseases Protein Deficiency Protein-Energy Malnutrition Severe Acute Malnutrition

Age range

6 month–59 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Queen Elizabeth Central Hospital

Blantyre, Malawi

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

HIV-infected about to start on HAART for the first time
6-59 months old

Exclusion criteria

also being treated for TB
other chronic illness (e.g., congenital heart disease, cerebral palsy)

Treatment and study plan

zidovudine, lamivudine, nevirapine

Drug

Primary outcomes

Pharmacokinetics

Time frame: 6 weeks

PK of ART in malnourished children

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

ART Pharmacokinetics, Mitochondrial Integrity, and Antioxidant Capacity in Severely Malnourished HIV-infected Malawian Children

Acronym: ARMAM

Important dates

Study start: 2011
Primary completion: 2012
Study completion: 2012
First posted: Feb 8, 2012
Registry last updated: Jan 23, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed