HIVORCHIDNCT04991402
Obesogenic Origins of Maternal and Child Metabolic Health Involving Dolutegravir
An observational study of HIV and Obesity, run by Columbia University at 2 sites in South Africa.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 16 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV, Obesity, Obesity, Infant
- What is being tested?
- Dolutegravir-based antiretroviral therapy
- Type of treatment
- Medical device
- How many people
- 1,920 participants
- Where
- 2 sitesSouth Africa
- Study dates
- 21 Sep 2021to 30 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The investigator will recruit up to 1900 pregnant women at their 1st antenatal clinic visit. Enrollment will be distributed across three main exposure categories by HIV status and Dolutegravir use: pregnant women living with HIV and initiating DTG-based ART in pregnancy (iDTG); pregnant women living with HIV already on DTG-based regimen prior to pregnancy and continuing DTG through pregnancy (cDTG); and pregnant women without HIV infection.
Who may be able to join
- For All Women:
- Confirmed pregnancy based on urine pregnancy test with viable gestation ≤ 18 weeks and 6 days by ultrasound
- Age 16 years or older
- No stated intention to relocate permanently outside of Cape Town through 2 years postpartum
- For Women Living with HIV (WLHIV):
- Confirmed HIV infection based on medical record review and/or HIV antibody testing during antenatal care
Show all 12Show fewer
- For WLHIV continuing DTG in pregnancy (cDTG):
- Confirmed use of tenofovir 300mg + lamivudine 300mg/emtricitabine 200mg + dolutegravir 50mg (TLD) on the day of assessment
- For WLHIV initiating DTG in pregnancy (iDTG):
- Planned initiation of TLD on the day of assessment or within 1 week thereafter, including women switching from efavirenz-based regimen
- For women without HIV (HIV-):
- Confirmed HIV status by HIV antibody testing during antenatal care
Who cannot join
- In the opinion of the investigator, unable to provide informed consent due to mental or physical condition
- In the opinion of the investigator, unable to undertake BodPod assessment due to mental (eg, active psychosis or severe claustrophobia) or physical condition (eg, weight >250 kg).
- Currently being treated for any form of diabetes mellitus or hypertensive disorder based on participant self-report and medical record review
Trial locations and contacts
2 sites in 1 country.
South Africa2 sites
Gugulethu Community Health Center
Cape Town
Mitchell's Plain Community Health Center
Cape Town
About this study
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.
Read the detailed description
Dolutegravir (DTG)-based antiretroviral therapy (ART) is being scaled up as part of the preferred 1st-line ART regimen. However, DTG has recently been implicated as an obesogen that is associated with increased weight and adipose tissue gain compared to other antiretroviral agents. Obesity in pregnancy is associated with poor health outcomes for both mother and child as pregnancy is a critical period during which exposures leading to alterations in metabolic health may influence not only long-term maternal health but also fetal, neonatal, and ultimately child health. To address the gap of knowledge on the obesogenic effects of DTG in pregnant women living with HIV (WLHIV) and their children, this prospective cohort study will investigate the impact of DTG in pregnancy and its obesogenic effects on the metabolic health of WLHIV and their children, compared to women without HIV and their children. Up to 1900 pregnant women will be enrolled and followed to delivery and then as mother-infant pairs through 5 years postpartum (ORCHID study main cohort).
Additionally, a nested cohort study will be conducted and enroll a subset of 108 pregnant women who are currently being followed as part of the parent ORCHID study's main cohort. This substudy will explore the associations of DTG (initiating and continuing DTG use during pregnancy) with longitudinal perturbations in subcutaneous adipose tissue (SAT) function and changes in weight and adipose tissue mass in pregnancy through 2 years postpartum in WLHIV using a comparison group of HIV-seronegative women. They will been seen at up to 3 different time points (up to 2 visits during pregnancy and 1 visit postpartum) separate from the parent study to undergo a fat biopsy procedure to extract SAT samples.
- Conditions
- HIV, Obesity, Obesity, Infant, Maternal Obesity During Childbirth, Maternal Obesity Complicating Pregnancy
- Being tested
- Dolutegravir-based antiretroviral therapy
- Keywords
- HIV, Dolutegravir, Metabolic health, Maternal obesity, Pregnancy
- Medical subject headings
- Obesity, Pediatric Obesity, Pregnancy in Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dolutegravir-based antiretroviral therapyDevice
This study focuses on the impact of Dolutegravir (DTG)-based antiretroviral therapy (ART) on metabolic health of women and children in pregnancy, delivery and beyond. In order to understand the potential adverse effects of DTG, pregnant women living with HIV- both those initialing DTG-based ART in pregnancy as well as those who were established on DTG-based ART prior to pregnancy, will be less than or equal to 18 weeks' gestation at enrollment to allow for detection of metabolic abnormalities as they begin to develop during the course of pregnancy.
This is considered standard of care.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women living with HIV initiating Dolutegravir (DTG) in pregnancy (iDTG) | Pregnant women living with HIV initiating DTG-based ART in pregnancy at the 1st visit Receives: Device: Dolutegravir-based antiretroviral therapy | |
| Pregnant women living with HIV already on DTG-based ART prior to pregnancy (cDTG) | Pregnant women living with HIV already on DTG-based ART prior to enrollment and continuing DTG use through pregnancy Receives: Device: Dolutegravir-based antiretroviral therapy | |
| HIV uninfected pregnant women | Pregnant women not living with HIV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in excess gestational weight gain between pregnant women living with HIV and HIV negative pregnant women
This is to measure the difference in gestational weight gain between pregnant women living with HIV and HIV negative pregnant women during pregnancy in kg. The women will be weighed by a scale at the study visit.
Measured: <18 weeks (baseline), 32-34 weeks
Difference in gestational weight gain between iDTG and cDTG pregnant women
This is to measure the difference in gestational weight gain between pregnant women initiating DTG during pregnancy (iDTG) and pregnant women continuing DTG during pregnancy (cDTG) in kg. The mothers will be weighed by a scale at the study visit.
Measured: <18 weeks (baseline), 32-34 weeks
Change in adipose tissue mass compared between pregnant women living with HIV and HIV negative pregnant women
Comparison of percent adipose tissue mass per week between pregnant women living with HIV and HIV negative pregnant women during pregnancy.
Measured: <18 weeks (baseline), 32-34 weeks
Change in adipose tissue mass compared between iDTG and cDTG mothers
Comparison of percent adipose tissue mass per week between pregnant women initiating DTG during pregnancy (iDTG) and pregnant women continuing DTG during pregnancy (cDTG).
Measured: <18 weeks (baseline), 32-34 weeks
Differences in maternal metabolic health post-partum between mothers living with HIV and HIV negative mothers
Adiposity will be measured as the main indicator of metabolic health. This outcome focuses on the comparison between mothers living with HIV and HIV negative mothers during pregnancy. Differences in adipose accrual and/or retention will calculated as the difference in adipose (% per week) between the timepoint in question and baseline.
Measured: <18 weeks antenatal, 24 weeks postpartum, and 24 months postpartum
Differences in maternal metabolic health post-partum between iDTG and cDTG mothers
Adiposity will be measured as the main indicator of metabolic health. This outcome focuses on the comparison between mothers initiating DTG during pregnancy and mothers continuing DTG during pregnancy. Differences in adipose accrual and/or retention will calculated as the difference in adipose (% per week) between the timepoint in question and baseline.
Measured: <18 weeks antenatal, 24 weeks postpartum, and 24 months postpartum
Changes in adiposity in the child between HIV positive mothers and HIV negative mothers
Adiposity will be measured as the main indicator of metabolic health. This outcome focuses on the comparison between children whose mothers are HIV positive and those whose mothers are HIV negative. Differences in adipose accrual and/or retention will calculated as the difference in adipose (% per week) between the timepoint in question and baseline.
Measured: <2 weeks, up to 2 years of age
Changes in adiposity in the child between iDTG and cDTG mothers
Adiposity will be measured as the main indicator of metabolic health. This outcome focuses on the comparison between children whose mothers initiated DTG during pregnancy and those whose mothers continued DTG during pregnancy. Differences in adipose accrual and/or retention will calculated as the difference in adipose (% per week) between the timepoint in question and baseline.
Measured: <2 weeks, up to 2 years of age
Secondary outcomes (1)
Changes in subcutaneous adipose tissue (SAT) function
The SAT sample will reveal information regarding adipocyte hypertrophy, hypoxia, increased fibrosis and inflammation, decreased SAT mitochondrial respiration, and any altered metabolome/lipidome.
Measured: <18 weeks (baseline), 32-34 weeks antenatal, 24 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2021
- Study start21 Sep 2021
- Primary completion30 May 2025
- Study completion30 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,920 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Northwestern University, University of Cape Town, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of Hawaii, Tufts University, Albert Einstein College of Medicine
- Responsible party
- Principal investigator, Elaine J. Abrams, MD, Columbia University
- Investigators
- Elaine J. Abrams, MD, Principal investigator, ICAP at Columbia UniversityJennifer Jao, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04991402
- Sponsor's protocol ID
- AAAT6112
- Other IDs
- 1R01HD104599
- Acronym
- ORCHID
- Status last verified
- Feb 2026
- First submitted
- 23 Jun 2021
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: As required by study funder, de-identified, archived data will be transmitted to and stored at National Institute of Child Health and Human Development (NICHD)'s Data and Specimen Hub (DASH) for use by other researchers including those outside of the study. Permission to transmit data to DASH will be included in the informed consent signed by all study participants. This data will be shared after the end of the study.
Publications
Kupsco A, Jao J, Myer L, Abrams EJ, Wang F, Dominguez J, Zerbe A, Mukonda E, Madlala HP, Matyesini S, Robinson DT, Qiu Y, Kurland IJ, Wu H. A multiomic investigation of human milk-derived extracellular vesicles in perinatal HIV and antiretroviral therapy exposure. Mol Med. 2026 Jul 16. doi: 10.1186/s10020-026-01567-5. Online ahead of print.
PubMed 42464111Abrams EJ, Jao J, Madlala HP, Zerbe A, Catalano P, Gerschenson M, Goedecke JH, Gomba Y, Josefson J, Kurland IJ, Legbedze J, McComsey GA, Matyesini S, Mukonda E, Robinson D, Myer L. 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. PLoS One. 2024 Aug 19;19(8):e0307296. doi: 10.1371/journal.pone.0307296. eCollection 2024.
PubMed 39159183
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obesogenic Origins of Maternal and Child Metabolic Health Involving Dolutegravir
- ClinicalTrials.gov ID
- NCT04991402
- Acronym / sponsor ID
- ORCHID / AAAT6112
- Conditions
- HIV, Obesity, Obesity, Infant, Maternal Obesity During Childbirth, Maternal Obesity Complicating Pregnancy
- Keywords
- HIV, Dolutegravir, Metabolic health, Maternal obesity, Pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,920 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Northwestern University, University of Cape Town, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of Hawaii, Tufts University, Albert Einstein College of Medicine
- Study start
- 21 Sep 2021 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 5 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Dolutegravir (DTG)-based antiretroviral therapy (ART) is being scaled up as part of the preferred 1st-line ART regimen. However, DTG has recently been implicated as an obesogen that is associated with increased weight and adipose tissue gain compared to other antiretroviral agents. Obesity in pregnancy is associated with poor health outcomes for both mother and child as pregnancy is a critical period during which exposures leading to alterations in metabolic health may influence not only long-term maternal health but also fetal, neonatal, and ultimately child health. To address the gap of knowledge on the obesogenic effects of DTG in pregnant women living with HIV (WLHIV) and their children, this prospective cohort study will investigate the impact of DTG in pregnancy and its obesogenic effects on the metabolic health of WLHIV and their children, compared to women without HIV and their children. Up to 1900 pregnant women will be enrolled and followed to delivery and then as mother-infant pairs through 5 years postpartum (ORCHID study main cohort).
Additionally, a nested cohort study will be conducted and enroll a subset of 108 pregnant women who are currently being followed as part of the parent ORCHID study's main cohort. This substudy will explore the associations of DTG (initiating and continuing DTG use during pregnancy) with longitudinal perturbations in subcutaneous adipose tissue (SAT) function and changes in weight and adipose tissue mass in pregnancy through 2 years postpartum in WLHIV using a comparison group of HIV-seronegative women. They will been seen at up to 3 different time points (up to 2 visits during pregnancy and 1 visit postpartum) separate from the parent study to undergo a fat biopsy procedure to extract SAT samples.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pregnant women living with HIV initiating Dolutegravir (DTG) in pregnancy (iDTG) | – | Device: Dolutegravir-based antiretroviral therapyPregnant women living with HIV initiating DTG-based ART in pregnancy at the 1st visit |
| Pregnant women living with HIV already on DTG-based ART prior to pregnancy (cDTG) | – | Device: Dolutegravir-based antiretroviral therapyPregnant women living with HIV already on DTG-based ART prior to enrollment and continuing DTG use through pregnancy |
| HIV uninfected pregnant women | – | –Pregnant women not living with HIV |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The investigator will recruit up to 1900 pregnant women at their 1st antenatal clinic visit. Enrollment will be distributed across three main exposure categories by HIV status and Dolutegravir use: pregnant women living with HIV and initiating DTG-based ART in pregnancy (iDTG); pregnant women living with HIV already on DTG-based regimen prior to pregnancy and continuing DTG through pregnancy (cDTG); and pregnant women without HIV infection.
Key inclusion criteria (12 listed)
- Confirmed pregnancy based on urine pregnancy test with viable gestation ≤ 18 weeks and 6 days by ultrasound
- Age 16 years or older
- No stated intention to relocate permanently outside of Cape Town through 2 years postpartum
- Confirmed HIV infection based on medical record review and/or HIV antibody testing during antenatal care
- Confirmed use of tenofovir 300mg + lamivudine 300mg/emtricitabine 200mg + dolutegravir 50mg (TLD) on the day of assessment
Key exclusion criteria (3 listed)
- In the opinion of the investigator, unable to provide informed consent due to mental or physical condition
- In the opinion of the investigator, unable to undertake BodPod assessment due to mental (eg, active psychosis or severe claustrophobia) or physical condition (eg, weight >250 kg).
- Currently being treated for any form of diabetes mellitus or hypertensive disorder based on participant self-report and medical record review
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dolutegravir-based antiretroviral therapyThis study focuses on the impact of Dolutegravir (DTG)-based antiretroviral therapy (ART) on metabolic health of women and children in pregnancy, delivery and beyond. In order to understand the potential adverse effects of DTG, pregnant women living with HIV- both those initialing DTG-based ART in pregnancy as well as those who were established on DTG-based ART prior to pregnancy, will be less than or equal to 18 weeks' gestation at enrollment to allow for detection of metabolic abnormalities as they begin to develop during the course of pregnancy. This is considered standard of care. | Device | Pregnant women living with HIV already on DTG-based ART prior to pregnancy (cDTG), Pregnant women living with HIV initiating Dolutegravir (DTG) in pregnancy (iDTG) |
Primary outcome
Difference in excess gestational weight gain between pregnant women living with HIV and HIV negative pregnant women
Time frame: <18 weeks (baseline), 32-34 weeks
This is to measure the difference in gestational weight gain between pregnant women living with HIV and HIV negative pregnant women during pregnancy in kg. The women will be weighed by a scale at the study visit.
Difference in gestational weight gain between iDTG and cDTG pregnant women
Time frame: <18 weeks (baseline), 32-34 weeks
This is to measure the difference in gestational weight gain between pregnant women initiating DTG during pregnancy (iDTG) and pregnant women continuing DTG during pregnancy (cDTG) in kg. The mothers will be weighed by a scale at the study visit.
Change in adipose tissue mass compared between pregnant women living with HIV and HIV negative pregnant women
Time frame: <18 weeks (baseline), 32-34 weeks
Comparison of percent adipose tissue mass per week between pregnant women living with HIV and HIV negative pregnant women during pregnancy.
Change in adipose tissue mass compared between iDTG and cDTG mothers
Time frame: <18 weeks (baseline), 32-34 weeks
Comparison of percent adipose tissue mass per week between pregnant women initiating DTG during pregnancy (iDTG) and pregnant women continuing DTG during pregnancy (cDTG).
Differences in maternal metabolic health post-partum between mothers living with HIV and HIV negative mothers
Time frame: <18 weeks antenatal, 24 weeks postpartum, and 24 months postpartum
Adiposity will be measured as the main indicator of metabolic health. This outcome focuses on the comparison between mothers living with HIV and HIV negative mothers during pregnancy. Differences in adipose accrual and/or retention will calculated as the difference in adipose (% per week) between the timepoint in question and baseline.
Differences in maternal metabolic health post-partum between iDTG and cDTG mothers
Time frame: <18 weeks antenatal, 24 weeks postpartum, and 24 months postpartum
Adiposity will be measured as the main indicator of metabolic health. This outcome focuses on the comparison between mothers initiating DTG during pregnancy and mothers continuing DTG during pregnancy. Differences in adipose accrual and/or retention will calculated as the difference in adipose (% per week) between the timepoint in question and baseline.
Changes in adiposity in the child between HIV positive mothers and HIV negative mothers
Time frame: <2 weeks, up to 2 years of age
Adiposity will be measured as the main indicator of metabolic health. This outcome focuses on the comparison between children whose mothers are HIV positive and those whose mothers are HIV negative. Differences in adipose accrual and/or retention will calculated as the difference in adipose (% per week) between the timepoint in question and baseline.
Changes in adiposity in the child between iDTG and cDTG mothers
Time frame: <2 weeks, up to 2 years of age
Adiposity will be measured as the main indicator of metabolic health. This outcome focuses on the comparison between children whose mothers initiated DTG during pregnancy and those whose mothers continued DTG during pregnancy. Differences in adipose accrual and/or retention will calculated as the difference in adipose (% per week) between the timepoint in question and baseline.
1 secondary outcome
Changes in subcutaneous adipose tissue (SAT) function
Time frame: <18 weeks (baseline), 32-34 weeks antenatal, 24 months postpartum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
- Derived from this study: PubMed 42464111Kupsco A, Jao J, Myer L, Abrams EJ, Wang F, Dominguez J, Zerbe A, Mukonda E, Madlala HP, Matyesini S, Robinson DT, Qiu Y, Kurland IJ, Wu H. A multiomic investigation of human milk-derived extracellular vesicles in perinatal HIV and antiretroviral therapy exposure. Mol Med. 2026 Jul 16. doi: 10.1186/s10020-026-01567-5. Online ahead of print.
- Derived from this study: PubMed 39159183Abrams EJ, Jao J, Madlala HP, Zerbe A, Catalano P, Gerschenson M, Goedecke JH, Gomba Y, Josefson J, Kurland IJ, Legbedze J, McComsey GA, Matyesini S, Mukonda E, Robinson D, Myer L. 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. PLoS One. 2024 Aug 19;19(8):e0307296. doi: 10.1371/journal.pone.0307296. eCollection 2024.
- Individual participant dataSharing planned: Yes. As required by study funder, de-identified, archived data will be transmitted to and stored at National Institute of Child Health and Human Development (NICHD)'s Data and Specimen Hub (DASH) for use by other researchers including those outside of the study. Permission to transmit data to DASH will be included in the informed consent signed by all study participants. This data will be shared after the end of the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elaine J. Abrams, MD principal investigator
ICAP at Columbia University
Jennifer Jao, MD principal investigator
Northwestern University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV and Obesity, run by Columbia University at 2 sites in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in excess gestational weight gain between pregnant women living with HIV and HIV negative pregnant women (time frame: <18 weeks (baseline), 32-34 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04991402, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026.