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Doravirine Dose Optimisation in Pregnancy

NCT05630638 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2026-02-19

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Doravirine

Fixed dose combination of doravirine, lamivudine and tenofovir disoproxil

DRUG

Dolutegravir

Fixed dose combination of dolutegravir, lamivudine and tenofovir disoproxil

Sponsors & Collaborators

  • Liverpool School of Tropical Medicine

    collaborator OTHER

  • Desmond Tutu Health Foundation

    collaborator OTHER

  • University of Liverpool

    lead OTHER

Principal Investigators

  • Saye Khoo · University of Liverpool

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-10
Primary Completion
2028-07-31
Completion
2028-07-31

Countries

  • South Africa

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05630638 on ClinicalTrials.gov