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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Washington University School of Medicine

ClinicalTrials.gov Identifier:

NCT01529125

First received: February 3, 2012

Last updated: January 22, 2014

Last verified: January 2014

History of Changes

Purpose

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.

Condition	Intervention
Kwashiorkor Marasmus Severe Acute Malnutrition HIV	Drug: zidovudine, lamivudine, nevirapine


Study Type:	Observational
Study Design:	Observational Model: Case Control Time Perspective: Prospective
Official Title:	ART Pharmacokinetics, Mitochondrial Integrity, and Antioxidant Capacity in Severely Malnourished HIV-infected Malawian Children

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS Malnutrition

U.S. FDA Resources

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:

Pharmacokinetics [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
PK of ART in malnourished children


Enrollment:	42
Study Start Date:	July 2011
Study Completion Date:	September 2012
Primary Completion Date:	September 2012 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Kwashiorkor HIV-positive children aged 6-59 months with kwashiorkor receiving nutritional rehabilitation and who are started on HAART.	Drug: zidovudine, lamivudine, nevirapine
Marasmus HIV-positive children aged 6-59 months with marasmus receiving nutritional rehabilitation and who are started on HAART.	Drug: zidovudine, lamivudine, nevirapine
Control HIV-positive children aged 6-59 months who are not severely malnourished and who are started on HAART for a non-nutritional reason.	Drug: zidovudine, lamivudine, nevirapine

Eligibility


Ages Eligible for Study:	6 Months to 59 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Children aged 6-59 months with HIV and kwashiorkor and marasmus who are not currently on HAART will be recruited from the Nutritional Rehabilitation Unit at Queen Elizabeth Central Hospital in Blantyre, Malawi. Controls will be recruited from the outpatient cotrimoxazole clinic who are about to start on HAART for a non-nutritional reason.

Criteria

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)

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01529125

Locations


Malawi
Queen Elizabeth Central Hospital
Blantyre, Malawi

Sponsors and Collaborators

Washington University School of Medicine

Investigators


Principal Investigator:	Mark J Manary, MD	Washington University School of Medicine

More Information

No publications provided


Responsible Party:	Washington University School of Medicine
ClinicalTrials.gov Identifier:	NCT01529125 History of Changes
Other Study ID Numbers:	ARTMAM
Study First Received:	February 3, 2012
Last Updated:	January 22, 2014
Health Authority:	Malawi: College of Medicine Research and Ethics Committee United States: Institutional Review Board

ClinicalTrials.gov processed this record on March 03, 2015

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