A5391: Doravirine for Persons with Excessive Weight Gain on Integrase Inhibitors & TAF: The DO-IT Study

 in Clinical Trials / People Living With HIV  tagged Doravirine / HIV belly / HIV research / HIV TAF / HIV treatment / HIV treatment study / HIV weight gain / People Living With HIV by

Title:

A5391: Doravirine for Persons with Excessive Weight Gain while taking Integrase Inhibitors and Tenofovir Alafenamide (TAF): The DO-IT Study

Click here for printable participant summary.

Description:

Weight gain after starting anti-HIV medicines is common, but recent studies have found that taking certain medicines may cause increased weight more than others. People living with HIV who are taking certain integrase strand transfer inhibitors (INSTI) combined with TAF/FTC (or TAF/3TC) may gain more weight than people taking other drug combinations. The INSTI that this study is looking at are bictegravir (BIC), dolutegravir (DTG) and raltegravir (RAL). (The names and types of anti-HIV medicines can be confusing. Some “one-a-day” pills have several medicines in them. If you are not sure if your anti-HIV medicines are included in the study, the research staff can help you figure it out.)

Researchers are looking to see if people who have gained a large amount of weight after starting or switching to these INSTI-containing regimen can either reduce their rate of weight gain over time or even lose weight with a change to different anti-HIV medicines.

Study Products:

Doravirine will be provided by the study. TAF/FTC (TAF/3TC); TDF/FTC (TDF/3TC); and INSTIs will not be provided by the study. Participants will need to receive them from their regular provider.

Requirements:

  • Living with HIV and are 18 years of age or older;
  • Currently taking an INSTI (BIC, DTG or RAL) as anti-HIV medicine with TAF/FTC (or TAF/3TC);
  • Taking an INSTI for more than 48 weeks before study entry;
  • Weight gain of more than 10% in the 1-3 years after starting (or switching to) an INSTI-based anti-HIV medicine regimen;
  • Undetectable viral loads both sooner and more than 48 weeks before study entry;
  • No pregnancy/breastfeeding or intention to become pregnant or breastfeed during study;
  • If participants are sexually active and capable of becoming pregnant, must agree to use contraception while on study and for 8 weeks after the end of the study;
  • Transgender participants taking gender-affirming hormones, must be on a stable hormone dose for more than 12 weeks prior to study entry with no plans to change hormone regimen or dose
  • There are other inclusion/exclusion criteria the staff can discuss with you.

Duration of Study:

Participants will be in this study for 48 weeks.

Compensation Provided

NIH study page: clinicaltrials.gov/ct2/show/NCT04636437