DTG/ABC/3TC in Pregnant Women
Research type
Research Study
Full title
A Prospective, Interventional Pharmacokinetic and Safety Study of DTG/ABC/3TC in Pregnant Women
IRAS ID
150032
Contact name
Margaret Johnson
Contact email
Sponsor organisation
Viiv Healthcare
Eudract number
2013-003527-11
ISRCTN Number
xx
Clinicaltrials.gov Identifier
xx
Research summary
This study, sponsored by ViiV Healthcare, is to look at the safety of dolutegravir/abacavir/lamivudine (DTG/ABC/3TC) in pregnant women and how much of the drug is in their blood.
Dolutegravir is an integrase inhibitor which is a fairly new class of antiretroviral drugs designed to block the action of a specific enzyme. This enzyme works in several key steps in the HIV life cycle so blocking it may help people with HIV infection. It is taken as a single tablet once daily.
Unlike ABC and 3TC, no studies have been conducted with DTG in pregnant women.
Eligible participants are HIV-infected women who have become unintentionally pregnant during study ING117172 and were taking DTG/ABC/3TC. This study will allow these women continued access to DTG/ABC/3TC in a single tablet.
Based on previous studies, it is anticipated that about 12 participants will enroll in the study in about 12 countries globally.
Following withdrawal from ING117172, participants will complete Screening and Day 1 visits for ING200336 and continue to receive DTG/ABC/3TC.
Participants will have study visits every month until delivery. These visits will include standard blood tests, urine tests, questions about medical history and special blood tests when participants have to stay 12 hours at the clinic to have 9 blood samples taken then return the next morning for an additional sample.
Immediately after delivery, another blood test will be required from the mother and the umbilical cord, if possible. Another study visit will then take place 8-12 weeks after delivery when another special blood test will be required.
Participants will continue to have access to DTG/ABC/3TC after the final study visit until either it is locally approved and commercially available, until they no longer derive clinical benefit, until they meet a protocol-defined reason for discontinuation, or until development of the compound is terminated.REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
14/LO/0590
Date of REC Opinion
28 May 2014
REC opinion
Further Information Favourable Opinion