Safety and Metabolic Study of Highly Active Antiretrovira... | NCT01529125

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

NCT01529125

Sponsor

Washington University School of Medicine

Status

Completed

Last Update Posted

Jan 23, 2014Estimated

Enrollment

42Actual

Phase

Not provided

Conditions

Kwashiorkor
Marasmus
Severe Acute Malnutrition
HIV

Interventions

zidovudine, lamivudine, nevirapine

Countries

Malawi

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2011

Primary Completion Date

Sep 2012Actual

Completion Date

Sep 2012Actual

First Submitted Date

Feb 3, 2012

First Submission Date that Met QC Criteria

Feb 7, 2012

First Posted Date

Feb 8, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 22, 2014

Last Update Posted Date

Jan 23, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

42Actual

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
zidovudine, lamivudine, nevirapine	Drug		Control Kwashiorkor Marasmus

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pharmacokinetics	PK of ART in malnourished children	6 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Months

Maximum Age

59 Months

Standard Ages

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mark J Manary, MD	Washington University School of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Queen Elizabeth Central Hospital		Blantyre			Malawi

Condition Browse Module

MeSH Terms

ID	Term
D007732	Kwashiorkor
D011502	Protein-Energy Malnutrition
D000067011	Severe Acute Malnutrition

Ancestor Terms

ID	Term
D044342	Malnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases
D011488	Protein Deficiency

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015215	Zidovudine
D019259	Lamivudine
D019829	Nevirapine

Ancestor Terms

ID	Term
D013936	Thymidine
D011741	Pyrimidine Nucleosides
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring

Browse Leaves

Not provided

Browse Branches

Not provided