The DO-IT Study

For people living with HIV who are experiencing excessive weight gain

while taking HIV treatments

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ACTG 5391

Doravirine for Persons with Excessive Weight Gain

on Integrase Inhibitors and Tenofovir Alafenamide

Purpose of this Investigational Study: 

 

We want to understand why some people gain excessive weight while taking HIV treatment, and whether switching the HIV treatment regimen can help.

 

Body weight can change throughout our lifetime and is influenced by multiple factors.

 

Previous studies showed that people living with HIV may gain more weight when taking an integrase inhibitor, especially with tenofovir alafenamide (TAF). When compared to other regimens, these studies also showed that women and African Americans were disproportionately impacted by weight changes while on HIV treatment with integrase inhibitors.

The DO IT study will answer these important questions for individuals who have gained substantial weight while taking an integrase inhibitor (bictegravir [BIC], dolutegravir [DTG], or raltegravir [RAL]) with TAF.

 

It is designed to compare weight change for those who either stay with their current regimen or switch to a regimen with doravirine (DOR).

 

There will be three groups:

 

          Group 1: DOR + TAF/FTC

 

          Group 2: DOR + TDF/FTC

 

          Group 3: will continue on their current treatment regimen

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Eligibility Factors for this Study:

  • People living with HIV

  • Ages 18 and older

  • Overweight (BMI > 27.5 kg/m2) and excessive weight gain (>10%) over the past 1-3 years

  • Currently on HIV treatment including BIC, DTG, or RAL and TAF regimen for at least 48 weeks:

    • If you started one of these integrase inhibitors and TAF at different times, you should be on TAF for at least 48 weeks

    • If you began TAF w/another integrase inhibitor, you should be on a BIC, DTG, or RAL-containing regimen for at least 24 weeks.

  • HIV viral load of 50 or less

 

Length of Study: 

Approximately 48 weeks

 

 

Schedule of Study Appointments:  

  • Three fasting visits (*)

  • Entry (*), week 4, week 8, week 12, week 24 (*), week 36, and week 48 (*)

 

 

Medications administered during study:

 

Arm 1 & 2 receives doravirine, Arm 3 stays with their current integrase inhibitor.

 

All three groups will also include on a TAF or TDF-containing regimen.

 

Study Procedures:  

Medical histories, Physical exams, Blood draws & two DEXA scans

 

Reimbursement: 

$20 per visit starting with the screening visit, and $20 for each DEXA scan

 

Contact: 

ACTU Screening Nurse at either 206-744-8883 (phone) or 206-733-7129 (text)

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Understanding Excessive Weight Gain on Newer HIV Treatments

The topic of our June 2021 Community Advisory Board (CAB) meeting was about the excessive weight gain on the newer HIV regimens containing Biktarvy, Tivicay, Isentress or Descovy.

 

Dr. Brian Wood answers our questions and explains the DO-IT Study to us--a clinical trials that seeks to investigate why this weight gain is happening and if we can reverse it.