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
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Condition or disease | Intervention/treatment |
---|---|
Kwashiorkor Marasmus Severe Acute Malnutrition HIV | Drug: zidovudine, lamivudine, nevirapine |
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 |
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 |
- Pharmacokinetics [ Time Frame: 6 weeks ]PK of ART in malnourished children

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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 |
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)

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
Malawi | |
Queen Elizabeth Central Hospital | |
Blantyre, Malawi |
Principal Investigator: | Mark J Manary, MD | Washington University School of Medicine |
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 |