Evaluation of Bone Mineral Density in HIV-1 Infected Adults
Research type
Research Study
Full title
An evaluation of bone mineral density in HIV-1-infected adult subjects switching from a tenofovir-containing antiretroviral therapy regimen to a dolutegravir plus rilpivirine regimen
IRAS ID
180227
Contact name
Frank Post
Contact email
Sponsor organisation
ViiV Healthcare
Clinicaltrials.gov Identifier
Parent study 201636 EudraCT number, 2014-005147-40; Parent study 201637 EudraCT number, 2014-005148-16
Duration of Study in the UK
3 years, 1 months, 13 days
Research summary
This study (202094) is looking at the change in bone mineral density (BMD) in subjects who are participating in one of 2 studies for HIV-1 infected adults, 201636 (SWORD-1) or 201637 (SWORD-2).
BMD is a measure of the strength of bones and is calculated using a low level X-ray test called a DEXA scan. Some people treated for HIV have been shown to have decreased bone strength.
Approximately 150 subjects in about 10 countries globally will participate. About 16 of these will be in the UK. The study is sponsored by ViiV Healthcare.
Eligible participants will be screened but not yet randomised into SWORD-1 or SWORD-2. They will be taking tenofovir disoproxil fumarate (TDF).
The first study visit for 202094 will involve a DEXA scan, a blood test and some questions about the participant’s lifestyle. Following this, participants will have a screening period of up to 28 days to ensure eligibility.
At the Day 1 study visit, as part of SWORD-1 or SWORD-2, participants will be randomly assigned to either dolutegravir plus rilpivirine or to continue on TDF. Participants will then have 202094 study visits at weeks 48, 100 and 148 which will coincide with their SWORD-1 or SWORD-2 visits. A DEXA scan will take place at each study visit. Other assessments will include lifestyle questions (eg smoking history, alcohol consumption), weight and height, and a review of adverse events and medications.
Participants will complete the study at week 148.REC name
South West - Cornwall & Plymouth Research Ethics Committee
REC reference
15/SW/0195
Date of REC Opinion
7 Aug 2015
REC opinion
Further Information Favourable Opinion