NCT04991402: ORCHID

Obesogenic Origins of Maternal and Child Metabolic Health Involving Dolutegravir

Completed Last updated 19 February 2026

What this trial tests

trial testing Dolutegravir-based antiretroviral therapy in HIV in 1,920 participants. Completed in 30 May 2025.

Timeline

21 September 2021

Primary endpoint
30 May 2025

30 May 2025

Quick facts

Lead sponsor	Columbia University
Status	Completed
Study type	OBSERVATIONAL
Enrollment	1,920
Start date	21 September 2021
Primary completion	30 May 2025
Estimated completion	30 May 2025
Sites	2 locations across South Africa

Drugs / interventions tested

• Dolutegravir-based antiretroviral therapy

Conditions studied

• HIV — all drugs for HIV →
• Obesity — all drugs for Obesity →
• Obesity, Infant — all drugs for Obesity, Infant →
• Maternal Obesity During Childbirth — all drugs for Maternal Obesity During Childbirth →

Sponsor

Columbia University

Who can join

16 and older, female only, with HIV or Obesity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

A total of 1900 pregnant women in the 1st trimester and their children will be enrolled and followed for two years (ORCHID study main cohort). As part of this, mother-infant pairs will be required to attend up to 10 study visits separate from routine clinic visits, these visits include 3 antenatal visits (less than or equal to 18, 24-28 and 32-36 weeks) and 16 postnatal visits (\<2 and 6 weeks, 3, 6, 12, 18, and 24 months). Participants will also be asked to engage in long-term follow-up, with visits occurring every 6 months through Month 60 (at 30, 36, 42, 48, 54, and 60 months). Measurements in mothers will include demographics and health status, HIV disease and ART use, intercurrent medical history including concomitant medication use, HIV viral load testing, ART adherence, HIV antibody testing in women without HIV; body composition, caloric intake, dysglycemia and insulin resistance (IR), lipid profiles, anthropometry, resting energy expenditure, hepatic steatosis, specimen collection (whole blood, plasma, serum, urine, placenta and breastmilk), systemic and adipose inflammation, as well as metabolites, lipid subspecies and eicosanoids. Measurements in infants will include uterine gestational age and fetal growth, as well as metabolites, lipid subspecies and eicosanoids, body composition, dysglycemia and IR, lipid profiles, anthropometry, feeding, specimen collection (cord blood, whole blood, plasma and serum) and intercurrent medical history including concomitant medication use. Additional data on maternal health in pregnancy and birth outcomes will be abstracted from medical records.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Global estimates of tuberculosis incidence during pregnancy and postpartum: a rapid review and modelling analysis.
   Mafirakureva N, Cartledge A, Bradshaw I, Bekker A, et al · · 2026 · cited 4× · PMID 41519136 · DOI 10.1016/s2214-109x(25)00431-0
2. An observational cohort study to investigate the impact of dolutegravir in pregnancy and its obesogenic effects on the metabolic health of women living with HIV and their children: Study protocol.
   Abrams EJ, Jao J, Madlala HP, Zerbe A, et al · · 2024 · cited 4× · PMID 39159183 · DOI 10.1371/journal.pone.0307296