Change in Body Weight and BMI in PWH with DOR/3TC/TDF Compared with INSTI

Launched by INSTITUTO MEXICANO DEL SEGURO SOCIAL · Sep 17, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of changing HIV treatment on body weight and body mass index (BMI) in men who have gained weight after starting their HIV medication. Specifically, it looks at patients who have been on certain types of HIV treatments for at least 36 months and have experienced at least a 10% increase in weight. To be eligible, participants must be at least 25 years old, have a BMI of 25 or higher, and have certain levels of body fat.

If you choose to participate, you'll sign a consent form and then, using a mobile app, you will be randomly assigned to either continue your current HIV treatment or switch to a new one that includes specific medications. Throughout the year, you'll have regular medical visits to monitor your health, including tests for fat levels, blood sugar, liver and kidney function, and HIV control. You'll also complete questionnaires about your mental well-being, such as feelings of depression or anxiety. This trial aims to see if changing treatments can help with weight loss in those who have gained weight due to their HIV medication.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Virologically suppressed for at least 48 weeks prior to study entry
• • 2. Coming from a regimen containing Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF), Dolutegravir/Lamivudine/Abacavir (DTG/3TC/ABC), or, Dolutegravir/Tenofovir Disoproxil Fumarate/Emtricitabine (DTG+TDF/FTC) with no known failures to integrase inhibitors for al least 48 weeks.
• • 3. BMI ≥25 kg/m2 at screening and
• • 4. Unintentional weight gain of \>10% from baseline (prior to INSTI initiation) within 1-3 years of starting INSTI ART, with no other apparent medical reason to explain the weight gain (concomitant medication use, Cushing's disease, recent prolonged hospitalization, etc.), in the opinion of the site investigator.
• • 5. Body fat percentage \>20%
• • 6. No indication or plans to add or change medications associated with significant weight change during the study period.
• • 7. Participants currently receiving antipsychotics, antidepressants, anticonvulsants/mood stabilizers, and thyroid replacement hormones without dose modifications for at least 12 weeks prior to randomization
• • 8. Participants currently receiving antidiabetics known to cause weight loss and without dose modifications for at least 24 weeks prior to randomization (GLP-1 receptor agonists, SGLT-2 inhibitors, insulin, metformin).
• • 9. Agree to adhere to assigned ART during the study period
• • 10. HIV-1 RNA screening \<50 copies/mL performed within 45 days prior to study entry.
• • 11. GFR by CDK-EPI ≥60 mL/min
• • 12. Alanine aminotransferase (ALT) and asparatate aminotransferase (AST) \< 90 IU/L
• • 13. Thyroid profile (TSH, free T3 and free T4) prior to entering the study
• • 14. Serum and urinary electrolytes, cystatin C, prior to entering the study
• Exclusion Criteria:
• • 1. Loss of social security
• • 2. Allergy to any of the components of ART, previously unknown.
• • 3. Withdrawal of informed consent
• • 4. Acquiring HBV and/or HCV infection during follow-up.
• • 5. HIV-1 RNA \>200 copies/mL in 2 consecutive determinations after having achieved virological suppression.
• • 6. Early initiation or discontinuation of any of the following drugs after entering the study: antipsychotics (clozapine, olanzapine, risperidone); antidepressants (tricyclic antidepressants, selective serotonin reuptake inhibitors) monoamine oxidase inhibitors, associated with weight gain; anticonvulsants/mood stabilizers (lithium, valproic acid) or associated with weight loss (topiramate); thyroid replacement hormones;
• • 7. Change in dose or discontinuation of antidiabetic drugs that cause weight loss (GLP-1 receptor agonists, SGLT-2 inhibitors, insulin, metformin), after entering the study.
• • 8. Planning to undergo or having undergone bariatric surgery.
• • 9. Initiating significant dietary changes, advised by a nutritionist according to what was reported by the participant
• • 10. Initiating or increasing physical exercise or enrolling in a structured weight loss regimen: \<250 minutes/week of moderate to intense activity