Effect of Doravirine on Weight and BMI in HIV Patients

Change in Body Weight and BMI in PWH Virologically Suppressed Who Maintain a Second-generation INSTI Regimen Compared to Those Who Switch to DOR/3TC/TDF At 48 Weeks

This study is testing if switching HIV patients who have gained weight to a new medication combination including doravirine can help them lose weight and improve their health over 48 weeks.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 108 (estimated)
• Ages: 18 Years to 80 Years
• Sex: Male
• Sponsor: Instituto Mexicano del Seguro Social (Government)
• Locations: 2 sites (Mexico City, Azcapotzalco and 1 other locations)
• Trial ID: NCT06602622 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the impact of switching HIV patients who have gained weight on integrase inhibitors to a regimen containing doravirine, lamivudine, and tenofovir disoproxil fumarate. Participants must be virologically suppressed and have experienced significant weight gain while on their current antiretroviral therapy. The study will monitor changes in body weight and BMI over a 48-week period, with regular medical visits and laboratory evaluations to assess health parameters. The trial is conducted at the La Raza National Medical Center in Mexico City.

Who should consider this trial

Good fit: Ideal candidates are HIV patients who are virologically suppressed, have a BMI of 25 kg/m2 or higher, and have gained at least 10% of their body weight after starting antiretroviral therapy.

Not a fit: Patients who have not experienced significant weight gain or those with other medical conditions affecting weight may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for HIV patients struggling with weight gain associated with their current therapy.

How similar studies have performed: Other studies have explored weight management in HIV patients, but this specific approach using doravirine is relatively novel.

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

Where this trial is running

Mexico City, Azcapotzalco and 1 other locations

• Hospital de infectología, Centro Médico Nacional La Raza — Mexico City, Azcapotzalco, Mexico (Recruiting)
• Hospital de infectología, Centro Médico Nacional La Raza — Mexico City, Azcapotzalco, Mexico (Recruiting)

Study contacts

• Study coordinator: Ana L Cano, Postgraduate

Conditions HIV; HIV Associate Weight Loss; HIV-1 Infection; Integrase Inhibitors, HIV; HIV PROTEASE INHIB; Weight Change; Weight Loss; Integrase inhibitors