DOLOMITE: A Cohort Study to assess DTG Safety in HIV Pregnant Women
Research type
Research Study
Full title
A multi-site observational study to define the safety and effectiveness of Dolutegravir use in HIV positive pregnant women
IRAS ID
264010
Contact name
Laura Waters
Contact email
Sponsor organisation
President of the NEAT ID Foundation
Clinicaltrials.gov Identifier
NCT03564613, clinicaltrials.gov
Duration of Study in the UK
3 years, 0 months, 4 days
Research summary
Research Summary
294 pregnancies where the mother was exposed to Dolutegravir, 281 babies were born alive. There were 2 stillbirths, 8 planned terminations, 13 miscarriages, and 2 pregnancies where the outcome wasn’t known.
The typical age of the pregnant individuals was 33 years, with most people falling between 27 and 37 years old.
At the time of delivery, 86.4% of mothers had an undetectable HIV viral load (below 50 copies/mL). No babies acquired HIV from their mothers.
There was one baby born with trisomy 13, and six side effects possibly linked to the medication, which included two cases of headache, and single cases of hepatitis, high blood pressure, raised liver enzymes.
Among the 261 babies where gestational age was known, 44 (16.9%) were born prematurely, and 7 (2.7%) were born very prematurely (before 32 weeks).
Among the 259 babies where weight at birth was known, 46 (17.8%) had a low birth weight (under 2,500 grams) and 8 (3.1%) had a very low birth weight (under 1,500 grams).
21 birth defects were identified in 18 babies, giving a rate of 7.2%. No neural tube defects occurred.The DOLOMITE study is looking at the use of Dolutegravir (DTG), a integrase strand transfer inhibitor for the treatment of adult and adolescent (age 12 and over) with HIV-1 in combination with other antiretroviral agents. DTG-regimen are recommended during pregnancy only if the potential benefit outweighs the risk to the foetus. In May 2018 preliminary findings from the Tsepamo study showed a higher than expected number of neural tube defects among new-borns whose mothers were exposed to DTG regimen at conception. Following this the FDA guidance recommended that due to the potential risk DTG should be avoided during the first trimester.
The purpose of this study is to assess the safety and effectiveness of DTG use in HIV positive pregnant women. This is a multi-site observational study looking to enrol between 230 to 500 HIV positive women who were/are exposed to DTG at least once during their pregnancy across Europe and Canada. The data collected as part of the study will be retrospective or prospective data that is obtained during routine standard of care assessments and the participants will not undergo any study procedures, medication or visits. The enrolment period will be over 2 years with a 1-year follow-up period for outcomes.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
19/EM/0135
Date of REC Opinion
20 May 2019
REC opinion
Further Information Favourable Opinion