Dolutegravir/abacavir/lamivudine vs a standard HIV regimen in females
Research type
Research Study
Full title
A Phase IIIb randomised, open-label study of the safety and efficacy of dolutegravir/abacavir/lamivudine once daily compared to atazanavir and ritonavir plus tenofovir/emtricitabine once daily in HIV-1 infected antiretroviral therapy naive women.
IRAS ID
135620
Contact name
Margaret Johnson
Contact email
Sponsor organisation
Viiv Healthcare
Eudract number
2012-005823-34
Clinicaltrials.gov Identifier
Research summary
This study is looking at the safety and efficacy of dolutegravir/abacavir/lamivudine (DTG/ABC/3TC) in a single tablet versus atazanavir (ATV) plus ritonovir (RTV) plus tenofovir/emtricitabine (TDF/FTC) over 48 weeks in HIV infected women.
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 once daily unlike other available integrase inhibitors which are taken twice daily.
Little data on dolutegravir in women is available from other studies due to lower enrollment of women compared with men.
This study will include approximately 474 subjects in about 13 countries globally and is sponsored by Viiv Healthcare.
Eligible HIV-infected women will be aged 18 years or over. They should have a viral load of >/=500c/ml and not previously have received any antiretroviral treatment.
Following their first visit, participants will have a screening period of up to 28 days to ensure eligibility prior to starting study treatment. Participants will then be randomly assigned to either DTG/ABC/3TC or atazanavir plus ritonavir plus TDF/FTC. They will know which treatment they are receiving. Participants will have visits at week 4 and 12 then every 12 weeks until week 48. Assessments will include Treatment Satisfaction questionnaires, physical examinations, an ECG and blood samples.
Subjects receiving ATV+RTV+TDF/FTC will complete the study after Week 48 and will need to have made alternative arrangements to access antiretroviral medication.
Subjects receiving DTG/ABC/3TC who complete 48 weeks of treatment will continue to have access to it 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
13/LO/1302
Date of REC Opinion
11 Oct 2013
REC opinion
Further Information Favourable Opinion