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

February 3, 2012
January 22, 2014
July 2011
September 2012   (final data collection date for primary outcome measure)
Pharmacokinetics [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
PK of ART in malnourished children
Not Provided
Complete list of historical versions of study NCT01529125 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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

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.

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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.

  • Kwashiorkor
  • Marasmus
  • Severe Acute Malnutrition
  • HIV
Drug: zidovudine, lamivudine, nevirapine
  • Kwashiorkor
    HIV-positive children aged 6-59 months with kwashiorkor receiving nutritional rehabilitation and who are started on HAART.
    Intervention: Drug: zidovudine, lamivudine, nevirapine
  • Marasmus
    HIV-positive children aged 6-59 months with marasmus receiving nutritional rehabilitation and who are started on HAART.
    Intervention: 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.
    Intervention: Drug: zidovudine, lamivudine, nevirapine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
September 2012
September 2012   (final data collection date for primary outcome measure)

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)
Both
6 Months to 59 Months
No
Contact information is only displayed when the study is recruiting subjects
Malawi
 
NCT01529125
ARTMAM
No
Washington University School of Medicine
Washington University School of Medicine
Not Provided
Principal Investigator: Mark J Manary, MD Washington University School of Medicine
Washington University School of Medicine
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP