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HIV drug dosing study aims to protect moms and babies

NCT ID NCT05630638

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 study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looks at how the HIV drug doravirine works in pregnant women. Researchers want to find the right dose to keep the virus under control and protect the baby. About 76 pregnant women with HIV will take either doravirine or standard HIV medication starting in the second trimester. The study will measure drug levels in the blood, breastmilk, and cord blood to ensure safety and effectiveness.

What this could mean

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

Active substance
Doravirine (with lamivudine and tenofovir disoproxil)
What this could lead to
If successful, this could help establish safe and effective doravirine dosing for pregnant women with HIV, improving treatment options during pregnancy.
What could go wrong
This is a small, early-phase pharmacokinetic study, not designed to prove long-term outcomes. Results may not apply to all populations, and there are unknown risks to the baby.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 76 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2023

Expected to finish

Jul 2028

An estimate. End dates often move.

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: * Women ≥ 18 years old * Ability to give informed consent prior to participation * Willing and able to comply with all study requirements * HIV positive * Pregnant (initiating cART ≥ 12 weeks and \< 26 weeks gestation) * Intention to breastfeed postpartum Exclusion Criteria: * Received any cART in preceding 6 months * Chronic hepatitis B (HBV) infection with clinical evidence of transaminitis * 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) * Previous documented failure of an NNRTI-containing cART regimen * Previous history of hypersensitivity to any ARV * Concomitant medication which are inducers of SoC and DOR metabolism (e.g. rifampicin, anti-epileptic agents, rifabutin, St John's Wort, mitotane, enzalutamide, lumacaftor). Contraindicated medications can be found on Liverpool Drug Interactions website (hiv-druginteractions.org) * Participants with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption cannot take DOR as the tablet contains lactose monohydrate * Clinical depression or clinical judgment suggests increased risk of suicidality

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Conditions

The condition(s) this trial relates to.

HIV infectious disease

As listed by the trial registrant

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

HIV

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Desmond Tutu Health Foundation

    RECRUITING

    Cape Town, South Africa

    Contact Email: •••••@•••••

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