RecruitingPhase 4NCT05630638

Doravirine Dose Optimisation in Pregnancy


Sponsor

University of Liverpool

Enrollment

76 participants

Start Date

Oct 10, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

A randomised, open label, controlled PK standard of care vs doravirine plus 2 nucleoside reverse transcriptase inhibitors backbone in pregnant women initiating combination antiretroviral therapy in the second trimester of pregnancy.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating the best dose of doravirine — an HIV medication — during pregnancy and breastfeeding. HIV drug levels in the body change during pregnancy, and the standard dose may not be effective enough. The study aims to find the optimal dose to protect both the mother and the baby from HIV. **You may be eligible if...** - You are an HIV-positive woman, 18 or older - You are pregnant (between 12 and 26 weeks of gestation) and starting combination HIV treatment for the first time in at least 6 months - You plan to breastfeed after delivery - You are able and willing to follow study procedures **You may NOT be eligible if...** - You have received HIV treatment in the past 6 months - You have chronic hepatitis B with liver inflammation - You have significant liver enzyme abnormalities - You have previously had a failed HIV treatment regimen using a similar class of drugs (NNRTIs) - You have had an allergic reaction to any HIV medication - You are taking medications that interact with doravirine (such as rifampicin or certain anti-epileptic drugs) - You have severe depression or are considered at risk for suicide Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDoravirine

Fixed dose combination of doravirine, lamivudine and tenofovir disoproxil

DRUGDolutegravir

Fixed dose combination of dolutegravir, lamivudine and tenofovir disoproxil


Locations(1)

Desmond Tutu Health Foundation

Cape Town, South Africa

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NCT05630638


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