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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexMale
Age18-80
SponsorInstituto Mexicano del Seguro Social

About this trial

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

Qualifiers

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) with no known failures to integrase inhibitors for al least 48 weeks.

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, Cushing's disease, recent prolonged hospitalization, etc.), in the opinion of the site investigator.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Integrase inhibitor
  • Doravirine + tenofovir DF + lamivudine

Treatment groups

108 Participants
are divided into 2 treatment groups