A Phase 4 interventional study of Zidovudine and Nevirapine in HIV, Insulin Sensitivity and Diabetes Mellitus, sponsored by Ann & Robert H Lurie Children's Hospital of Chicago. Completed at 1 site in Botswana. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-07-20.
Sponsored by Ann & Robert H Lurie Children's Hospital of Chicago · Phase 4, Interventional, and Prevention
The purpose of this study is to assess the early longitudinal metabolic effects including insulin sensitivity in HIV-exposed uninfected (HEU) children compared to HIV-unexposed uninfected (HUU) children; as well as to determine differences in the effects of neonatal zidovudine (AZT) vs. nevirapine (NVP) prophylaxis on early longitudinal changes in insulin sensitivity in the first 3 years of life.
This study will consist of a nested randomized component of HIV-infected (HIV+) and -uninfected (HIV-) pregnant woman/child dyads in Botswana which will take place in Gaborone, Botswana at Botswana-Harvard AIDS Institute Partnership's (BHPs) clinical research facilities. A total of 300 HIV+ pregnant woman/fetus dyads on cART and 150 HIV- pregnant woman/fetus dyads will be evaluated for insulin sensitivity and followed through the child's 3rd birthday. Amongst HEU infants, participants will be randomized at birth 1:1 with 150 to receive neonatal AZT prophylaxis and 150 to receive neonatal NVP prophylaxis. Targeted metabolomics will be used to assess the role intermediary metabolites in insulin resistance and directly assess mitochondrial function using Seahorse XF96e technology. At the time of study enrollment, all women must be willing to exclusively breastfeed for the infant's first 6 months of life. If in utero and neonatal HIV/ARV exposures are found to be associated with derangements in intermediary metabolism such that HEU infants are at increased risk for insulin resistance by 3 years of age, this would impact screening and prevention strategies for diabetes in this vulnerable population and argue for further research to identify prenatal and neonatal ARV regimens with superior PMTCT efficacy but minimal adverse metabolic consequences.
1,960 studies on the registry are indexed under Insulin Resistance; 306 are open to participants now.
This study's enrollment of 495 is above the median of 40 across 1,536 interventional studies indexed under Insulin Resistance.
Browse Insulin Resistance studies →Ann & Robert H Lurie Children's Hospital of Chicago is the lead sponsor of 176 studies on the registry; 30 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 5 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
•Pre-existing maternal diabetes mellitus.
150 HIV-Exposed Uninfected (HEU) infants on Nevirapine (NVP) Prophylaxis
Drug: Nevirapine
150 HIV-Exposed Uninfected (HEU) infants on Zidovudine (AZT) Prophylaxis
Drug: Zidovudine
150 HIV- unexposed Uninfected (HUU) Infants
neonatal 4 weeks prophylactic
Also known as: AZT
neonatal 4 weeks prophylactic
Also known as: NVP
Homeo-static Model Assessment-Insulin Resistance (HOMA-IR)
\[glucose (mg/dL) X insulin ( μU/mL)405\]
Time frame: up to 3 years
Plan to share: No
This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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Ann & Robert H Lurie Children's Hospital of Chicago