A5391: Doravirine for Persons with Excessive Weight Gain on Integrase Inhibitors and Tenofovir Alafenamide (The Do IT Study)
The Do IT Study - Study of Doravirine in PLWH with Excessive Weight Gain
Sponsor: National Institute of Allergy and Infectious Diseases
Enrolling: Male and Female Patients
Study Length: 48 Weeks
Clinic Visits: 7
IRB Number: AAAT6553
U.S. Govt. ID: NCT04636437
Contact: Anyelina Cantos: 212-305-7897 / ac4314@cumc.columbia.edu
Additional Study Information: Weight gain after starting antiretroviral therapy (ART) is common, but recent studies have found that some people living with HIV (PLWH) who are taking an integrase strand transfer inhibitor (INSTI) combined with tenofovir alafenamide/emtricitabine (TAF/FTC) or tenofovir alafenamide/lamivudine (TAF/3TC) may gain more weight than people taking other drug combinations. A rising number of PLWH are overweight or obese. Higher body mass index and weight gain on ART increase the risk for diabetes, heart disease, and stroke. Researchers are looking to see if PLWH who have gained a significant amount of weight after starting or switching to an INSTI-containing regimen, can either reduce their rate of weight gain over time or even lose weight with a change to a different ART regimen. This study will include participants who are living with HIV-1, who have been virally suppressed for more than 48 weeks on a regimen consisting of an INSTI and TAF/FTC or TAF/3TC and who have experienced more than 10% weight gain since the initiation of this ART regimen.
This study is closed
Investigator
Michael Yin, MD
Do You Qualify?
Are you at least 18 years old? Yes No
Have you been diagnosed with HIV-1? Yes No
Are you currently taking an Integrase Strand Transfer Inhibitor (INSTI)? Yes No
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You may be eligible for this study

Place Holder




For more information, please contact:
Anyelina Cantos
ac4314@cumc.columbia.edu
212-305-7897