What is this study trying to find out about HIV and weight in people living with HIV?

This study is comparing two ART regimens to evaluate their safety, tolerability, and effects on weight and health in people living with HIV who are overweight or obese. Researchers want to understand if weight gain after starting treatment is due to improved health or drug effects. The trial is sponsored by José Antonio Mata Marín and conducted at a national medical center.

Who may be eligible for this HIV clinical trial?

Adults aged 18 to 70 years with confirmed HIV who have not yet started ART may be eligible. Participants must have a BMI of 25 or higher and body fat over 20%. Anyone with recent use of PrEP or PEP or certain health conditions may not qualify. Please review eligibility criteria for more details.

Is there any cost to participate in this HIV clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered. Participants can expect regular visits for assessments during the study period.

Actively Recruiting

Phase 3

Age: 18Years - 70Years

All Genders

ID07075146

Comparing DoravirineLamivudineTenofovir Disoproxil Fumarate and BictegravirEmtricitabineTenofovir Alafenamide in Adults with HIV Who Are Overweight or Obese A Phase 3 Study in ART-Naive People Living with HIV

Led by José Antonio Mata Marín · Updated on 2025-08-24

306

Participants Needed

Research Sites

112 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the effectiveness, safety, and tolerability of two antiretroviral therapy ART regimens, DoravirineLamivudineTenofovir Disoproxil Fumarate DOR3TCTDF and BictegravirEmtricitabineTenofovir Alafenamide BICFTCTAF, 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

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

Research Team

José A Mata, M.Sc

Paola E Padilla, Student

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

Similar Trials

Virtual Nutrition Education to Prevent Weight Gain During Ma...

Acute Lymphoblastic Leukemia

Actively Recruiting

1 location

Study of Gene Expression in Tissues Related to Blood Sugar a...

Obesity

Actively Recruiting

1 location

Phase 1 Study of Single-Dose Semaglutide Nasal Spray to Asse...

Overweight

Actively Recruiting

1 location

Virtual Nutrition Education to Prevent Weight Gain During Maintenance Chemotherapy in Children and Adolescents with Acute Lymphoblastic Leukemia

Study of Gene Expression in Tissues Related to Blood Sugar and Weight in Adults Undergoing Abdominal Surgery

Phase 1 Study of Single-Dose Semaglutide Nasal Spray to Assess Safety, Tolerability, and Pharmacokinetics in Adults with Overweight or Obesity Aged 18 to 65

Reducing Obesity and Related Health Risks in Native American Employees at Twin Arrows Casino Using a Culturally Relevant Plant-Rich Diet

Phase 12a Study Evaluating Safety and Effects of ARO-ALK7 in Adults With Obesity, With or Without Type 2 Diabetes

Study of ARO-INHBE Injection in Adults with Obesity, With or Without Type 2 Diabetes, to Evaluate Safety and Effects

Phase 2 Study of Multiple Investigational Weight Management Treatments Using Injection and Oral Medications for Adults with Obesity or Overweight

Evaluating a New Digital Tool to Help Doctors Personalize Exercise Prescriptions for Adults with Cardiovascular Risk Factors

Testing a Responsive Parenting Program to Prevent Obesity in High-Risk Infants Through Pediatric Primary Care

Phase I Study of HRS-5817 Injection Given by Subcutaneous Injection in Healthy Adults Aged 18 to 55 With or Without Obesity

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

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/38831550/

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/

Comparing DoravirineLamivudineTenofovir Disoproxil Fumarate and BictegravirEmtricitabineTenofovir Alafenamide in Adults with HIV Who Are Overweight or Obese A Phase 3 Study in ART-Naive People Living with HIV

On this page

Sponsors

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Your Study Journey

Research Team

How is the study designed?

Similar Trials

Virtual Nutrition Education to Prevent Weight Gain During Ma...

Study of Gene Expression in Tissues Related to Blood Sugar a...

Phase 1 Study of Single-Dose Semaglutide Nasal Spray to Asse...

Frequently Asked Questions

What is this study trying to find out about HIV and weight in people living with HIV?

Who may be eligible for this HIV clinical trial?

Is there any cost to participate in this HIV clinical trial?

Will I receive Doravirine/Lamivudine/Tenofovir or Bictegravir/Emtricitabine/Tenofovir Alafenamide?

What body and health assessments will be done during the study?

What happens after this HIV clinical trial ends?

Can I leave this HIV clinical trial if I change my mind?

Not the Right Trial for You?

Published Research Related To This Trial

Weight change with antiretroviral switch from integrase inhibitor or tenofovir alafenamide-based to Doravirine-Based regimens in people with HIV.

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.

On this page

Sponsors

Sponsors

Who Can Participate

Eligibility Criteria

Your Study Journey

How is the study designed?

Similar Trials

Virtual Nutrition Education to Prevent Weight Gain During Ma...

Study of Gene Expression in Tissues Related to Blood Sugar a...

Phase 1 Study of Single-Dose Semaglutide Nasal Spray to Asse...

Frequently Asked Questions

What is this study trying to find out about HIV and weight in people living with HIV?

Who may be eligible for this HIV clinical trial?

Is there any cost to participate in this HIV clinical trial?

Will I receive Doravirine/Lamivudine/Tenofovir or Bictegravir/Emtricitabine/Tenofovir Alafenamide?

What body and health assessments will be done during the study?

What happens after this HIV clinical trial ends?

Can I leave this HIV clinical trial if I change my mind?

Published Research Related To This Trial

Weight change with antiretroviral switch from integrase inhibitor or tenofovir alafenamide-based to Doravirine-Based regimens in people with HIV.

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.

Sponsors