KwashiorkorARMAMNCT01529125
Safety and Metabolic Study of Highly Active Antiretroviral Therapy (HAART) in Malnourished Children With HIV
An observational study of Kwashiorkor and Marasmus, run by Washington University School of Medicine at 1 site in Malawi.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 59 months
- Conditions the study is for
- Kwashiorkor, Marasmus, Severe Acute Malnutrition
- What is being tested?
- zidovudine, lamivudine, nevirapine
- How many people
- 42 participants
- Where
- 1 siteMalawi
- Study dates
- Jul 2011to Sep 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 59 months
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- HIV-infected about to start on HAART for the first time
- 6-59 months old
Who cannot join
- also being treated for TB
- other chronic illness (e.g., congenital heart disease, cerebral palsy)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Kwashiorkor, Marasmus, Severe Acute Malnutrition, HIV
- Being tested
- zidovudine, lamivudine, nevirapine
- Medical subject headings
- Kwashiorkor, Protein-Energy Malnutrition, Severe Acute Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zidovudine, lamivudine, nevirapineDrug
| Study group | Role | What they receive |
|---|---|---|
| Kwashiorkor | HIV-positive children aged 6-59 months with kwashiorkor receiving nutritional rehabilitation and who are started on HAART. Receives: Drug: zidovudine, lamivudine, nevirapine | |
| Marasmus | HIV-positive children aged 6-59 months with marasmus receiving nutritional rehabilitation and who are started on HAART. Receives: 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. Receives: Drug: zidovudine, lamivudine, nevirapine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics
PK of ART in malnourished children
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2012 (estimated)
- Study startJul 2011
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KwashiorkorStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark J Manary, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01529125
- Sponsor's protocol ID
- ARTMAM
- Acronym
- ARMAM
- Status last verified
- Jan 2014
- First submitted
- 3 Feb 2012
- Last updated
- 23 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ART Pharmacokinetics, Mitochondrial Integrity, and Antioxidant Capacity in Severely Malnourished HIV-infected Malawian Children
- ClinicalTrials.gov ID
- NCT01529125
- Acronym / sponsor ID
- ARMAM / ARTMAM
- Conditions
- Kwashiorkor, Marasmus, Severe Acute Malnutrition, HIV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 8 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Kwashiorkor | – | Drug: zidovudine, lamivudine, nevirapineHIV-positive children aged 6-59 months with kwashiorkor receiving nutritional rehabilitation and who are started on HAART. |
| Marasmus | – | Drug: zidovudine, lamivudine, nevirapineHIV-positive children aged 6-59 months with marasmus receiving nutritional rehabilitation and who are started on HAART. |
| Control | – | Drug: zidovudine, lamivudine, nevirapineHIV-positive children aged 6-59 months who are not severely malnourished and who are started on HAART for a non-nutritional reason. |
Who may qualify
- Ages
- 6 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (2 listed)
- HIV-infected about to start on HAART for the first time
- 6-59 months old
Key exclusion criteria (2 listed)
- also being treated for TB
- other chronic illness (e.g., congenital heart disease, cerebral palsy)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| zidovudine, lamivudine, nevirapine | Drug | Control, Kwashiorkor, Marasmus |
Primary outcome
Pharmacokinetics
Time frame: 6 weeks
PK of ART in malnourished children
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark J Manary, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kwashiorkor and Marasmus, run by Washington University School of Medicine at 1 site in Malawi.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malawi. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2014; AzTrials last refreshed its copy on 8 Nov 2026.