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

NCT ID: NCT01529125

Last Updated: 2014-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

42 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-07-31

Study Completion Date

2012-09-30

Brief Summary

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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

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Conditions

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Kwashiorkor Marasmus Severe Acute Malnutrition HIV

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Kwashiorkor

HIV-positive children aged 6-59 months with kwashiorkor receiving nutritional rehabilitation and who are started on HAART.

zidovudine, lamivudine, nevirapine

Intervention Type DRUG

Marasmus

HIV-positive children aged 6-59 months with marasmus receiving nutritional rehabilitation and who are started on HAART.

zidovudine, lamivudine, nevirapine

Intervention Type DRUG

Control

HIV-positive children aged 6-59 months who are not severely malnourished and who are started on HAART for a non-nutritional reason.

zidovudine, lamivudine, nevirapine

Intervention Type DRUG

Interventions

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zidovudine, lamivudine, nevirapine

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

6 Months

Maximum Eligible Age

59 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mark J Manary, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

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Queen Elizabeth Central Hospital

Blantyre, , Malawi

Site Status

Countries

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Malawi

Other Identifiers

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ARTMAM

Identifier Type: -

Identifier Source: org_study_id

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