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
  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:


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

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders
Kwashiorkor
Protein-Energy Malnutrition
Protein Deficiency
Deficiency Diseases

ClinicalTrials.gov processed this record on October 19, 2014