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Doravirine Dose Optimisation in Pregnancy

NCT ID: NCT05630638

Last Updated: 2024-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-10

Study Completion Date

2026-02-28

Brief Summary

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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.

Detailed Description

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Women diagnosed HIV positive in the second trimester of pregnancy in South Africa will be enrolled and randomised 1:1 to receive standard of care or doravirine plus 2 NRTI backbone. Participants will receive study treatment until delivery and up to 28 weeks postpartum, with a maximum total of 14 months of study treatment. Given the high prevalence of NNRTI resistance, alternative ARV treatment options are essential. Doravirine is licenced for the treatment of HIV-1 in adults in North America and Europe. Whilst the efficacy and safety of doravirine has been established in non-pregnant adults, there are no adequate human data available to establish whether DOR poses a risk to pregnancy outcomes. It is important to have data on the safety and pharmacokinetics of the drug during pregnancy and in particularly the third trimester of pregnancy in order to support its use. The hypothesis for this study is that pregnancy influences the pharmacokinetics of doravirine when initiated in the second trimester.

Conditions

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HIV

Keywords

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Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Delstrigo

doravirine/lamivudine/tenofovir disoproxil 100 mg/ 300 mg/ 245 mg film coated tablets, dosed 1 tablet once daily for the duration of the study

Group Type EXPERIMENTAL

Doravirine

Intervention Type DRUG

Fixed dose combination of doravirine, lamivudine and tenofovir disoproxil

Standard of care

dolutegravir/lamivudine/tenofovir disoproxil 50 mg/300 mg/245 mg film coated tablets, dosed 1 tablet once daily for the duration of the study

Group Type ACTIVE_COMPARATOR

Dolutegravir

Intervention Type DRUG

Fixed dose combination of dolutegravir, lamivudine and tenofovir disoproxil

Interventions

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Doravirine

Fixed dose combination of doravirine, lamivudine and tenofovir disoproxil

Intervention Type DRUG

Dolutegravir

Fixed dose combination of dolutegravir, lamivudine and tenofovir disoproxil

Intervention Type DRUG

Other Intervention Names

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Delstrigo TLD

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Liverpool School of Tropical Medicine

OTHER

Sponsor Role collaborator

Desmond Tutu Health Foundation

OTHER

Sponsor Role collaborator

University of Liverpool

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Saye Khoo

Role: PRINCIPAL_INVESTIGATOR

University of Liverpool

Locations

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Desmond Tutu Health Foundation

Cape Town, , South Africa

Site Status RECRUITING

Countries

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South Africa

Central Contacts

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Helen Reynolds

Role: CONTACT

Phone: + 44 151 794 5553

Email: [email protected]

Facility Contacts

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Alicia James

Role: primary

Lauren Jennings

Role: backup

Catherine Orrell

Role: backup

Other Identifiers

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UoL001707

Identifier Type: -

Identifier Source: org_study_id