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Compares treatment options for HIV
Official title Change in Body Weight and BMI in PWH with DOR/3TC/TDF Compared with INSTI
ClinicalTrials.gov ID: NCT06602622
What this study is testing
What is Integrase inhibitor?
Integrase inhibitor is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for hiv.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80, men only
You may be able to join if
- Virologically suppressed for at least 48 weeks prior to study entry
- Coming from a regimen containing Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF), Dolutegravir/Lamivudine/Abacavir (DTG/3TC/ABC), or...
- BMI ≥25 kg/m2 at screening and
- Unintentional weight gain of \>10% from baseline (prior to INSTI initiation) within 1-3 years of starting INSTI ART, with no other apparent medical...
- Body fat percentage \>20%
You likely can't join if
- Loss of social security
- Allergy to any of the components of ART, previously unknown.
- Withdrawal of informed consent
- Acquiring HBV and/or HCV infection during follow-up.
- HIV-1 RNA \>200 copies/mL in 2 consecutive determinations after having achieved virological suppression.
- Early initiation or discontinuation of any of the following drugs after entering the study: antipsychotics (clozapine, olanzapine, risperidone)...
See the full eligibility criteria
- Virologically suppressed for at least 48 weeks prior to study entry
- 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)...
- BMI ≥25 kg/m2 at screening and
- 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...
- Body fat percentage \>20%
- No indication or plans to add or change medications associated with significant weight change during the study period.
- Participants currently receiving antipsychotics, antidepressants, anticonvulsants/mood stabilizers, and thyroid replacement hormones without dose modifications for at least 12 weeks prior to randomization
- 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).
- Agree to adhere to assigned ART during the study period
- HIV-1 RNA screening \<50 copies/mL performed within 45 days prior to study entry.
- GFR by CDK-EPI ≥60 mL/min
- Alanine aminotransferase (ALT) and asparatate aminotransferase (AST) \< 90 IU/L
- Thyroid profile (TSH, free T3 and free T4) prior to entering the study
- Serum and urinary electrolytes, cystatin C, prior to entering the study
- Loss of social security
- Allergy to any of the components of ART, previously unknown.
- Withdrawal of informed consent
- Acquiring HBV and/or HCV infection during follow-up.
- HIV-1 RNA \>200 copies/mL in 2 consecutive determinations after having achieved virological suppression.
- Early initiation or discontinuation of any of the following drugs after entering the study: antipsychotics (clozapine, olanzapine, risperidone); antidepressants (tricyclic antidepressants, selective serotonin reuptake...
- 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.
- Planning to undergo or having undergone bariatric surgery.
- Initiating significant dietary changes, advised by a nutritionist according to what was reported by the participant
- Initiating or increasing physical exercise or enrolling in a structured weight loss regimen: \<250 minutes/week of moderate to intense activity
The study team makes the final eligibility decision.
Where it's taking place
- Mexico City, Azcapotzalco, Mexico
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Mexico City, Azcapotzalco, Mexico. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.