Diabetes Mellitus Clinical Trial
Official title:
The Tshilo Dikotla Study: Metabolic Outcomes of Children HIV/ARV-Exposed Uninfected in Botswana (MOCHA)
Verified date | July 2022 |
Source | Ann & Robert H Lurie Children's Hospital of Chicago |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 495 |
Est. completion date | March 31, 2022 |
Est. primary completion date | March 31, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: •Pre-existing maternal diabetes mellitus. |
Country | Name | City | State |
---|---|---|---|
Botswana | Botswana-Harvard AIDS Institute Partnership | Gaborone |
Lead Sponsor | Collaborator |
---|---|
Ann & Robert H Lurie Children's Hospital of Chicago | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
Botswana,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Homeo-static Model Assessment-Insulin Resistance (HOMA-IR) | [glucose (mg/dL) X insulin ( µU/mL)405] | up to 3 years |
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