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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01529125

Acronym

ARMAM

Enrollment

Registered

2012-02-08

Start date

2011-07-31

Completion date

2012-09-30

Last updated

2014-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV, Kwashiorkor, Marasmus, Severe Acute Malnutrition

Brief summary

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.

Interventions

DRUGzidovudine, lamivudine, nevirapine

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

6 Months to 59 Months

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
Pharmacokinetics	6 weeks	PK of ART in malnourished children

Countries

Malawi

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026