NCT06602622 Change in Body Weight and BMI in PWH with DOR/3TC/TDF Compared with INSTI
| NCT ID | NCT06602622 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Instituto Mexicano del Seguro Social |
| Condition | HIV |
| Study Type | INTERVENTIONAL |
| Enrollment | 108 participants |
| Start Date | 2024-08-14 |
| Primary Completion | 2025-11-14 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 108 participants in total. It began in 2024-08-14 with a primary completion date of 2025-11-14.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Patients who developed metabolic syndrome after initiation of HIV treatment or with antiretroviral therapy (ART) for at least 36 months, treated with second generation integrase inhibitors (BIC/TAF/FTC, DTG/ABC/3Tc or DTG+TDF/FTC) who have gained at least 10% of their total body weight after starting ART, with a body mass index ≥25 kg/m2 and body fat greater than 20% will be eligible to participate in this clinical trial. If they decide to participate, they will sign an informed consent. After this, a mobile application will randomly decide whether the participant will continue with their ART regimen or switch to another ART (listed in the guidelines as one of the main lines of treatment) containing doravirine/lamivudine/disoproxil fumarate tenofovir. Medical visits will be at 1 month, 3 months, 6 months, 9 months, and 12 months after get in to this protocol, with laboratory studies that evaluate fats, blood sugar, liver function, kidney function, and test for HIV control; in addition, each visit will be given self-fillable scales to evaluate neuropsychiatric disorders such as depression, anxiety, insomnia, satisfaction with treatment or symptoms associated with it.The aim of the study is to observe whether there is weight loss with the change in HIV treatment.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06602622 clinical trial?
This trial is open to male participants only, aged 18 Years or older, up to 80 Years, studying HIV. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06602622 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06602622 currently recruiting?
Yes, NCT06602622 is actively recruiting participants. Contact the research team at ana.knodiaz@gmail.com for enrollment information.
Where is the NCT06602622 trial being conducted?
This trial is being conducted at Mexico City, Mexico, Mexico City, Mexico.
Who is sponsoring the NCT06602622 clinical trial?
NCT06602622 is sponsored by Instituto Mexicano del Seguro Social. The trial plans to enroll 108 participants.
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