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

Completed

• Conditions: HIV; Marasmus; Severe Acute Malnutrition; Kwashiorkor
• Interventions: Drug: zidovudine, lamivudine, nevirapine

• Registration Number: NCT01529125
• Lead Sponsor: Washington University School of Medicine

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2012-02-03
• Study First Submitted QC: 2012-02-07
• Study First Posted: 2012-02-08
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-22
• Last Update Posted: 2014-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

• HIV-infected about to start on HAART for the first time
• 6-59 months old

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Exclusion Criteria

• also being treated for TB
• other chronic illness (e.g., congenital heart disease, cerebral palsy)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Kwashiorkor	zidovudine, lamivudine, nevirapine	HIV-positive children aged 6-59 months with kwashiorkor receiving nutritional rehabilitation and who are started on HAART.
Control	zidovudine, lamivudine, nevirapine	HIV-positive children aged 6-59 months who are not severely malnourished and who are started on HAART for a non-nutritional reason.
Marasmus	zidovudine, lamivudine, nevirapine	HIV-positive children aged 6-59 months with marasmus receiving nutritional rehabilitation and who are started on HAART.

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics	6 weeks	PK of ART in malnourished children

Trial Locations

Locations (1)

Queen Elizabeth Central Hospital; 🇲🇼 Blantyre, Malawi