- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01529125
Safety and Metabolic Study of Highly Active Antiretroviral Therapy (HAART) in Malnourished Children With HIV (ARMAM)
January 22, 2014 updated by: Washington University School of Medicine
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
42
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Blantyre, Malawi
- Queen Elizabeth Central Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 months to 4 years (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Kwashiorkor
HIV-positive children aged 6-59 months with kwashiorkor receiving nutritional rehabilitation and who are started on HAART.
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Marasmus
HIV-positive children aged 6-59 months with marasmus receiving nutritional rehabilitation and who are started on HAART.
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Control
HIV-positive children aged 6-59 months who are not severely malnourished and who are started on HAART for a non-nutritional reason.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pharmacokinetics
Time Frame: 6 weeks
|
PK of ART in malnourished children
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6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2011
Primary Completion (ACTUAL)
September 1, 2012
Study Completion (ACTUAL)
September 1, 2012
Study Registration Dates
First Submitted
February 3, 2012
First Submitted That Met QC Criteria
February 7, 2012
First Posted (ESTIMATE)
February 8, 2012
Study Record Updates
Last Update Posted (ESTIMATE)
January 23, 2014
Last Update Submitted That Met QC Criteria
January 22, 2014
Last Verified
January 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nutrition Disorders
- Deficiency Diseases
- Protein Deficiency
- Malnutrition
- Severe Acute Malnutrition
- Protein-Energy Malnutrition
- Kwashiorkor
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Reverse Transcriptase Inhibitors
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Antimetabolites
- Cytochrome P-450 Enzyme Inducers
- Cytochrome P-450 CYP3A Inducers
- Nevirapine
- Lamivudine
- Zidovudine
Other Study ID Numbers
- ARTMAM
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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