Dolutegravir in Pregnant HIV Mothers and Their Neonates

DolPHIN-2

To evaluate dolutegravir (DTG) efficacy in women who present with untreated HIV in late pregnancy. An open-label, multi-centre randomised controlled trial of DTG vs efavirenz-based regimens for women commencing cART in late pregnancy. HIV positive pregnant women presenting with untreated HIV infection in late (≥28 weeks gestation) pregnancy will be randomised 1:1 to receive DTG (50mg once daily) + 2 nucleoside reverse transcriptase inhibitors (NRTIs) or EFV + 2 NRTIs (SoC)

2018-01-22

2020-10-20

2023-09-05

Completed

Early phase I

268

Inclusion Criteria: 1. Evidence of a personally signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study. 2. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. 3. Women aged 18 years or older 4. Pregnant ( ≥28 weeks gestation by best available gestation estimation) 5. Untreated HIV infection in late pregnancy Exclusion Criteria: 1. Received any antiretroviral drugs in previous 12 months 2. Ever received integrase inhibitors 3. Previous documented failure of an NNRTI-containing ART regimen, previous EFV-associated toxicity or other history of ARV use that would preclude randomisation based on investigator judgement 4. Serum haemoglobin \<8.0 g/dl 5. eGFR\<50 ml/min\* 6. 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). 7. History or clinical suspicion of unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hyperbilirubinaemia, oesophageal or gastric varices or persistent jaundice). 8. Severe pre-eclampsia (e.g. HELLP), or other pregnancy related events such as renal or liver abnormalities (e.g. grade 2 or above proteinuria,, total bilirubin, ALT or AST)\* at the time of enrolment 9. Paternal objection for infant participation in DTG arm (where disclosure has taken - applies to Uganda site only 10. Medical, psychiatric or obstetric condition that might affect participation in the study based on investigator judgement 11. Receiving any of the following medications (current or within past 2 weeks): anti-epileptic drugs, TB therapy, or other drugs known to significantly interact with either DTG or EFV

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'An open-label, multi-centre randomised controlled trial', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 268, 'type': 'ACTUAL'}}

2023-11-13