Weight change with antiretroviral switch from integrase inhibitor or tenofovir alafenamide-based to Doravirine-Based regimens in people with HIV.
Arianna E Kousari, Melissa P Wilson, Kellie L Hawkins...
https://pubmed.ncbi.nlm.nih.gov/38831550Actively Recruiting
Phase 3
Age: 18Years - 70Years
All Genders
ID07075146
Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate Compared With Bictegravir/Emtricitabine/Tenofovir Alafenamide in ART-Naive People Living With HIV Who Are Overweight or Obese
Led by José Antonio Mata Marín · Updated on 2025-08-24
306
Participants Needed
1
Research Sites
112 weeks
Total Duration
On this page
Sponsors
J
José Antonio Mata Marín
Lead Sponsor
I
Instituto Mexicano del Seguro Social
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness, safety, and tolerability of two antiretroviral therapy (ART) regimens, Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF) and Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF), in people living with HIV (PWH) who are overweight or obese and have not previously received ART. The study aims to understand whether weight gain observed after starting ART reflects a return to health or results from drug-related or metabolic effects, particularly with newer ART regimens containing integrase strand transfer inhibitors. This phase 3, open-label, randomized clinical trial will be conducted from May 2025 to May 2027 at a national medical center.
CONDITIONS
Brief Title
DOR/TDF/3TC COmpared With BIC/FTC/TAF in ART-Naïve People Living With HIV and Overweight or Obesity
Who Can Participate
Age: 18Years - 70Years
All Genders
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older with confirmed HIV diagnosis who have not received ART
- Signed informed consent to participate
- HIV-1 RNA viral load of at least 1000 copies/mL
- No prior failure of pre-exposure or post-exposure prophylaxis
- Body mass index (BMI) of 25 kg/m² or higher and body fat percentage greater than 20%
- Stable treatment for dyslipidemia if applicable
- No planned medication changes affecting weight
- Willingness to follow assigned antiretroviral therapy
- Recent HIV-1 RNA and CD4+ test results available
- Kidney function (GFR) of 60 mL/min or higher
- Liver enzymes ALT and AST below 90 IU/L
- Willingness to report changes in diet or physical activity during follow-up
You will not qualify if you...
- Uncontrolled diabetes or recent changes in insulin or hypoglycemic drugs within 3 months
- Active cancer
- History of bariatric surgery
- Allergies to study drugs
- Infection with hepatitis B or C
- Kidney function (GFR) below 60 mL/min
- Drug interactions with ART regimens
- Recent use of appetite suppressants within 60 days
- Recent hospitalization for severe illness within 30 days
- Unstable thyroid function
- Loss of social security coverage
- Withdrawal of consent
- Hepatitis B or C infection acquired during the study
- Use of psychiatric or thyroid medications without stable dosing for at least 12 weeks
- Starting or stopping medications affecting weight after enrollment
- Unplanned bariatric surgery during the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 144 weeks
Participants will receive one of two antiretroviral drug regimens and will be monitored for safety, tolerability, and effectiveness while taking the study medication.
Visits at weeks 4, 12, 24, 36, 48, 72, 96, 120, and 144
Trial Site Locations
Total: 1 location
1
Hospital de infectología, Centro Médico Nacional La Raza
Mexico City, Mexico, 02990
Actively Recruiting
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Research Team
J
José A Mata, M.Sc
P
Paola E Padilla, Student
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Safety and efficacy of doravirine as first-line therapy in adults with HIV-1: week 192 results from the open-label extensions of the DRIVE-FORWARD and DRIVE-AHEAD phase 3 trials.
Chloe Orkin, Jean-Michel Molina, Pedro Cahn...
https://pubmed.ncbi.nlm.nih.gov/38141637