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

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ClinicalTrials.gov Identifier: NCT01529125
Recruitment Status : Completed
First Posted : February 8, 2012
Last Update Posted : January 23, 2014
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment
Kwashiorkor Marasmus Severe Acute Malnutrition HIV Drug: zidovudine, lamivudine, nevirapine

Study Design
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Study Type : Observational
Actual Enrollment : 42 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: ART Pharmacokinetics, Mitochondrial Integrity, and Antioxidant Capacity in Severely Malnourished HIV-infected Malawian Children
Study Start Date : July 2011
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

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U.S. FDA Resources

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
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


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Pharmacokinetics [ Time Frame: 6 weeks ]
    PK of ART in malnourished children


Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   6 Months to 59 Months   (Child)
Sexes Eligible for Study:   All
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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01529125     History of Changes
Other Study ID Numbers: ARTMAM
First Posted: February 8, 2012    Key Record Dates
Last Update Posted: January 23, 2014
Last Verified: January 2014

Additional relevant MeSH terms:
Malnutrition
Severe Acute Malnutrition
Kwashiorkor
Protein-Energy Malnutrition
Nutrition Disorders
Protein Deficiency
Deficiency Diseases
Lamivudine
Zidovudine
Nevirapine
Reverse Transcriptase Inhibitors
 Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents
Antimetabolites
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers