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NCT01529125 Clinical Trial

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

HIV Clinical Trial

— ARMAM  

Official title:
ART Pharmacokinetics, Mitochondrial Integrity, and Antioxidant Capacity in Severely Malnourished HIV-infected Malawian Children

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01529125
Other study ID # ARTMAM
Secondary ID
Status Completed
Phase N/A
First received February 3, 2012
Last updated January 22, 2014
Start date July 2011
Est. completion date September 2012

Study information
Verified date January 2014
Source Washington University School of Medicine
Contact n/a
Is FDA regulated No
Health authority Malawi: College of Medicine Research and Ethics CommitteeUnited States: Institutional Review Board
Study type Observational

Clinical 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. This study will examine the safety, efficacy, and metabolism of children started on HAART while still severely malnourished.

Recruitment information / eligibility
Status Completed
Enrollment 42
Est. completion date September 2012
Est. primary completion date September 2012
Accepts healthy volunteers No
Gender Both
Age group 6 Months to 59 Months
Eligibility 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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• zidovudine, lamivudine, nevirapine

Locations
Country Name City State
Malawi Queen Elizabeth Central Hospital Blantyre

Sponsors (1)
Lead Sponsor Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

Malawi, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pharmacokinetics PK of ART in malnourished children 6 weeks Yes
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