Safety and Metabolic Study of Highly Active Antiretroviral Therapy (HAART) in Malnourished Children With HIV (ARMAM)
This study has been completed.
Sponsor:
Washington University School of Medicine
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
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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 (Child) |
| 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
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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
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
| 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 Severe Acute Malnutrition Kwashiorkor Protein-Energy Malnutrition Nutrition Disorders Protein Deficiency Deficiency Diseases Zidovudine Lamivudine Nevirapine Antimetabolites |
Molecular Mechanisms of Pharmacological Action Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Anti-HIV Agents Cytochrome P-450 CYP3A Inducers Cytochrome P-450 Enzyme Inducers |
ClinicalTrials.gov processed this record on September 23, 2016