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HIV drug Dolutegravir's impact on pregnancy weight under the microscope

NCT ID NCT04991402

Knowledge-focused Sponsor: Columbia University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study followed about 1,900 pregnant women and their babies for two years to see how HIV and the medication dolutegravir affect weight gain and overall metabolic health. Researchers compared women with HIV to those without, and also looked at differences between women who started dolutegravir during pregnancy versus those who were already taking it. The goal was to understand the links between HIV treatment, obesity, and health outcomes for both mothers and children.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

1,920 people

The number who actually took part.

Started

Sep 2021

Finished

May 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

16 years and older

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 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 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 Exclusion Criteria: * 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

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Conditions

The condition(s) this trial relates to.

HIV infectious disease Obesity obesity disorder Pediatric Obesity Pregnancy in Obesity

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HIV Maternal obesity complicating pregnancy Maternal obesity during childbirth Obesity Obesity, infant

Contacts and locations

Locations

  • Gugulethu Community Health Center

    Cape Town, South Africa

  • Mitchell's Plain Community Health Center

    Cape Town, South Africa

More trials for these conditions

Other studies related to the condition(s) this trial covers.