Phase 3
N=60
Safety and Pharmacokinetics of Dolutegravir in Pregnant HIV Mothers and Their Neonates: A Pilot Study
HIV · Pregnancy
Bottom Line
View on ClinicalTrials.gov: NCT02245022 ↗Enrolled (actual)
60
Serious AEs
5.0%
Results posted
Sep 2025
Primary outcome: Primary: AUC0-24 of DTG in Pregnant Women in Third Trimester and 2 Weeks Postpartum — 35322; 40127 ng*h/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Dolutegravir 50mg od (Drug); Standard of Care (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Liverpool
- Primary completion
- Dec 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY AUC0-24 of DTG in Pregnant Women in Third Trimester and 2 Weeks Postpartum |
35322; 40127 | — |
| PRIMARY Cmax of Dolutegravir |
2534; 2899 | — |
| PRIMARY Trough Concentration |
642; 777 | — |
| SECONDARY Number of Participants Reporting Severe Adverse Events During Study Period |
2; 1 | — |
| SECONDARY Percentage of Women in Each Arm With VL < 50 Copies/mL, and <400 Copies/mL at Delivery |
21; 12 | — |
| SECONDARY Cord:Maternal Plasma DTG Ratio |
1.21 | — |
| SECONDARY Maternal Plasma: Breastmilk DTG Ratio |
0.03 | — |
| SECONDARY Infant DTG Levels |
66.7 | — |
| SECONDARY Number and Severity of Adverse Events and Laboratory Abnormalities |
2; 0 | — |
| SECONDARY Percentage of Subjects Who Discontinue Treatment Due to Adverse Events |
0; 0 | — |
| SECONDARY Percentage of Mother to Child Transmission of HIV |
0; 0 | — |
| SECONDARY Pharmacogenomic Factors Influencing Transplacental and Breast Milk Transfer of Drug |
— | — |
Summary
Aim: To evaluate dolutegravir (DTG) pharmacokinetics in pregnant HIV-infected women
Rationale: In developing countries many women present with a new HIV diagnosis in late pregnancy, and are at high risk of transmitting infection during delivery. Moreover, women may acquire NNRTI resistance from primary transmission, or use of nevirapine (NVP) in previous pregnancies. In these circumstances, DTG is likely to be more effective in reducing mother to child transmission of HIV than NNRTI-based regimens.
Study design: HIV positive pregnant women presenting with untreated HIV infection in late (≥28 -36 weeks gestation) pregnancy will be randomised 1:1 to receive DTG (50mg once daily) or standard of care (nevirapine or efavirenz) + 2 NRTIs. PK (0-24h) profile will be sampled in third trimester and post-partum.
Although this is primarily a PK study (and has been powered as such) randomisation is included to allow comparison of plasma HIV VL responses against standard of care (NVP or EFV) and is essential for evaluation of secondary endpoints of safety and efficacy of DTG in pregnancy.
Number recruited N=30 per group
Eligibility Criteria
Inclusion Criteria
- Able to provide informed consent
- Willing to participate,
- Women age 18 years and above
- Pregnant
- Untreated HIV infection in late pregnancy at ≥28 - 36 weeks gestation
Exclusion Criteria
- Received antiretroviral drugs in previous 6 months
- Ever received integrase inhibitors
- Serum haemoglobin 5 times the upper limit of normal (ULN) or ALT >3xULN and bilirubin >2xULN (with >35% direct bilirubin)
- eGFR < 50ml/min
- Active Hepatitis B infection, history or clinical suspicion of unstable liver disease, or subjects with severe liver disease (Class C by Childs-Hugh criteria)
- Severe pre-eclampsia (e.g. HELLP), or other pregnancy related events such as renal or liver abnormalities (e.g. grade 2 or above proteinuria, elevation in serum creatinine (above 2.5 x ULN), total bilirubin ALT or AST)
- Paternal non-consent (where disclosure to male partner has been made)
- Clinical depression or clinical judgement suggests increased risk of suicidality
Data sourced from ClinicalTrials.gov (NCT02245022). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.