Study of HIV-Infected and Uninfected Pregnant Woman/Child Dyads in Gaborone, Botswana

NCT03088410 | Completed Phase 4 DMC FDA Drug

• 3 other identifiers: IRB 2019-2922R01DK109881HRDC 00781
• Study Type: interventional
• Target: 495
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV; Insulin Sensitivity; Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Homeo-static Model Assessment-Insulin Resistance (HOMA-IR)

  \[glucose (mg/dL) X insulin ( μU/mL)405\]

  up to 3 years

Study Arms (3)

Nevirapine

EXPERIMENTAL

150 HIV-Exposed Uninfected (HEU) infants on Nevirapine (NVP) Prophylaxis

Drug: Nevirapine

Zidovudine

ACTIVE COMPARATOR

150 HIV-Exposed Uninfected (HEU) infants on Zidovudine (AZT) Prophylaxis

Drug: Zidovudine

HIV- unexposed Uninfected (HUU) Infants

NO INTERVENTION

150 HIV- unexposed Uninfected (HUU) Infants

Interventions

Zidovudine DRUG

neonatal 4 weeks prophylactic

Also known as: AZT

Zidovudine

Nevirapine DRUG

neonatal 4 weeks prophylactic

Also known as: NVP

Nevirapine

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV-infected and uninfected pregnant women between 16-36 weeks GA are eligible for study enrollment.
• Women must be 18 years of older and able to provide informed consent for themselves and their infant to participate in the study.
• Participants must be Botswana citizens.
• Women must have evidence of HIV infection status. Women NOT documented as HIV seropositive must have documentation of HIV seronegativity during the present pregnancy at or after 32 weeks GA. Women who have an initial negative HIV test during the present pregnancy which was done at \<32 weeks GA will need to undergo repeat testing on or after 32 weeks GA in accordance with national guidelines.
• HIV-uninfected women must be willing to undergo HIV pre-test counseling, rapid HIV testing and post-test counseling, referred to as HIV Testing and Counseling (HTC) during pregnancy.
• Women must be willing to remain in study area with their infant and attend scheduled study visits as described above until the child's 3rd birthday.
• For HIV-infected women, they must be on TDF/3TC or FTC/EFV or TDF/3TC or FTC/Dolutegravir at time of study enrollment or willing to initiate this treatment and continue throughout the period of breastfeeding, if not for their lifetime.
• At enrollment, all women must be willing to breastfeed exclusively for the first six months of life.

You may not qualify if:

• Pre-existing maternal diabetes mellitus.

Sponsors & Collaborators

• Ann & Robert H Lurie Children's Hospital of Chicago: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Botswana-Harvard AIDS Institute Partnership

Gaborone, Botswana

Location

Related Publications (2)

• Banda FM, Powis KM, Sun S, Makhema J, Masasa G, Yee LM, Jao J. Fetal biometry following in-utero exposure to dolutegravir-based or efavirenz-based antiretroviral therapy. AIDS. 2020 Dec 1;34(15):2336-2337. doi: 10.1097/QAD.0000000000002674. No abstract available.

  PMID: 32910067 BACKGROUND

• Jao J, Sun S, Bonner LB, Legbedze J, Mmasa KN, Makhema J, Mmalane M, Kgole S, Masasa G, Moyo S, Gerschenson M, Mohammed T, Abrams EJ, Kurland IJ, Geffner ME, Powis KM. Lower Insulin Sensitivity in Newborns With In Utero HIV and Antiretroviral Exposure Who Are Uninfected in Botswana. J Infect Dis. 2022 Nov 28;226(11):2002-2009. doi: 10.1093/infdis/jiac416.

  PMID: 36240387 DERIVED

MeSH Terms

Conditions

Insulin Resistance; Diabetes Mellitus

Interventions

Zidovudine; Nevirapine

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Jennifer Jao, MD, MPH

  Ann & Robert H Lurie Children's Hospital of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Single blind - one party, either the investigator or participant, is unaware of the intervention assignment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 3, 2017
• First Posted: March 23, 2017
• Study Start: August 22, 2016
• Primary Completion: March 31, 2022
• Study Completion: March 31, 2022
• Last Updated: July 20, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

BO (1)