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New HIV drug shows promise for safer pregnancies

NCT ID NCT02245022

Disease control Sponsor: University of Liverpool 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study looked at whether the HIV drug dolutegravir is safe and effective in pregnant women who have not yet been treated for HIV. Sixty women in late pregnancy were randomly assigned to receive either dolutegravir or standard HIV medicines. The goal was to measure drug levels in the mother and check for side effects, with the hope of reducing the chance of passing HIV to the baby.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Dolutegravir (Tivicay)
What this could lead to
If successful, this could point toward a safer, more effective way to prevent HIV transmission from mother to baby during pregnancy and delivery.
What could go wrong
This is a small pilot study focused on drug levels, not large-scale proof of effectiveness. Results may not apply to all populations, and side effects in pregnancy are still being evaluated.

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.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

60 people

The number who actually took part.

Started

Mar 2017

Finished

Dec 2018

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.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Able to provide informed consent * Willing to participate, * Women age 18 years and above * Pregnant * Untreated HIV infection in late pregnancy at ≥28 - 36 weeks gestation Exclusion Criteria: * Received antiretroviral drugs in previous 6 months * Ever received integrase inhibitors * Serum haemoglobin \< 8.0 g/dl * Elevations in serum levels of alanine aminotransferase (ALT) \>5 times the upper limit of normal (ULN) or ALT \>3xULN and bilirubin \>2xULN (with \>35% direct bilirubin) * eGFR \< 50ml/min * Active Hepatitis B infection, history or clinical suspicion of unstable liver disease, or subjects with severe liver disease (Class C by Childs-Hugh criteria) * Severe pre-eclampsia (e.g. HELLP), or other pregnancy related events such as renal or liver abnormalities (e.g. grade 2 or above proteinuria, elevation in serum creatinine (above 2.5 x ULN), total bilirubin ALT or AST) * Paternal non-consent (where disclosure to male partner has been made) * Clinical depression or clinical judgement suggests increased risk of suicidality

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Conditions

The condition(s) this trial relates to.

Breast Feeding HIV infectious disease

As listed by the trial registrant

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

HIV Pregnancy

Contacts and locations

Locations

  • Desmond Tutu HIV Foundation

    Cape Town, Western Cape, South Africa

  • Infectious Diseases Institute

    Kampala, Uganda

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