Clinical Trial Details

DANCE: An open-label, single arm study to evaluate the week 48 efficacy and safety of a two-drug regimen of dolutegravir/lamivudine (DTG/3TC) as a fixed dose combination (FDC), in antiretroviral therapy (ART)-naïve HIV-1-infected adolescents, >12 to <18 years of age who weight at least 40kg
Study Description

The purpose of this study is to determine the efficacy and safety of two approved medicines, dolutegravir (DTG) plus lamivudine (3TC) taken together in adolescents and to understand how 22theseis new 21investigational combination of HIV medicines 22works in adolescents compared to adults. You have been asked to take part in the study because you have HIV-1 infection. The combination of DTG/3TC is considered experimental and is not yet approved for doctors to treat patients with HIV-1 infection, although the medicines are approved to treat HIV-1 infection together with other medicines.

This study will look at how this combination of medicine works in young people (participants aged 21=12 or older and =less than 18 years 22or younger) compared to how it works in adults (people 18 years or older). Everyone entering in this study must be aged =12 or older or younger than <18 years and must not be on HIV treatment regimen. At Day 1, all participants in this study will get DTG/3TC for once-daily dosing for 48 weeks. All participants who successfully complete 48 weeks of therapy and who continue to receive benefit from this two-drug regimen may receive DTG/3TC for 96 more weeks. You will take one tablet each day at approximately the same time, with or without food (the DTG/3TC regimen does not have to be taken with a meal). Information about how the study drug combination that you receive affects your body and your health will be collected through tests, procedures and questions. The effects of the drugs will be assessed after the study is complete.

Open Enrollment
Contact Name: Saniyyah Mahmoudi
Contact Phone: (904) 798-4115
Contact Email: