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

NCT01529125 | Completed

• 1 other identifier: ARTMAM
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Kwashiorkor; Marasmus; Severe Acute Malnutrition; HIV

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetics

  PK of ART in malnourished children

  6 weeks

Study Arms (3)

Kwashiorkor

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

Drug: zidovudine, lamivudine, nevirapine

Marasmus

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

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.

Drug: zidovudine, lamivudine, nevirapine

Interventions

zidovudine, lamivudine, nevirapine DRUG

Control; Kwashiorkor; Marasmus

Eligibility Criteria

• Age: 6 Months - 59 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Queen Elizabeth Central Hospital

Blantyre, Malawi

Location

MeSH Terms

Conditions

Kwashiorkor; Protein-Energy Malnutrition; Severe Acute Malnutrition

Interventions

Zidovudine; Lamivudine; Nevirapine

Condition Hierarchy (Ancestors)

Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Protein Deficiency; Deficiency Diseases

Intervention Hierarchy (Ancestors)

Thymidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dideoxynucleosides; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Zalcitabine; Deoxycytidine; Cytidine; Pyridines

Study Officials

• Mark J Manary, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2012
• First Posted: February 8, 2012
• Study Start: July 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: January 23, 2014

Record last verified: 2014-01

Locations

MA (1)