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Trial record 17 of 24 for:    " January 18, 2012":" February 17, 2012"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]
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Safety and Metabolic Study of Highly Active Antiretroviral Therapy (HAART) in Malnourished Children With HIV (ARMAM)

This study is currently recruiting participants.
Verified August 2012 by Washington University School of Medicine
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01529125
First received: February 3, 2012
Last updated: August 15, 2012
Last verified: August 2012
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:

U.S. FDA Resources

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

Estimated Enrollment: 114
Study Start Date: July 2011
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01529125

Locations
Malawi
Queen Elizabeth Central Hospital Recruiting
Blantyre, Malawi
Contact: Indi Trehan, MD MPH DTM&H         indi@alum.berkeley.edu    
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Mark J Manary, MD Washington University in St. Louis
  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: August 15, 2012
Health Authority: Malawi: College of Medicine Research and Ethics Committee
United States: Institutional Review Board

Additional relevant MeSH terms:
Kwashiorkor
Protein-Energy Malnutrition
Malnutrition
Protein Deficiency
Deficiency Diseases
Nutrition Disorders
Zidovudine
Nevirapine
Lamivudine
Antimetabolites
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on May 19, 2013