Compares two HIV treatments in newly diagnosed adults who are overweight or have obesity
Compares two HIV medicine combinations in newly diagnosed adults who are overweight or obese.
Plain-language title generated from the registry record
Registry title: DOR/TDF/3TC COmpared With BIC/FTC/TAF in ART-Naïve People Living With HIV and Overweight or Obesity
Key facts
- Where
- Mexico City, MexicoSee the site
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults newly diagnosed with HIV who have never taken HIV treatment and who are overweight or obese.
- Age
- 18 to 70 years
- Sex
- All sexes
- Disease stage
- Confirmed HIV with HIV-1 RNA of 1000 copies/mL or more; BMI of 25 kg/m² or more and body fat above 20%
- Earlier treatment
- Must never have taken HIV treatment (ART). No PrEP or PEP failure in the past.
- Biomarker or test result
- HIV-1 RNA ≥1000 copies/mL; recent HIV-1 RNA and CD4+ results; GFR ≥60 mL/min; ALT and AST below 90 IU/L
Main reasons for not taking part
- Hepatitis B and/or C infection
- Uncontrolled diabetes
- Active cancer
- Past bariatric (weight-loss) surgery
- Kidney function (GFR) below 60 mL/min
This trial only enrols participants living with HIV. The registry sentence this rests on: Adults (≥18 years) with confirmed HIV diagnosis, ART-naïve
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT07075146, who can take part
Where in Mexico
- Hospital de infectología, Centro Médico Nacional La RazaMexico City, MexicoTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- José Antonio Mata Marín
- Trial code
- NCT07075146
- Record updated
- 24 August 2025
- Original description
Background:Historically, HIV infection was associated with significant weight loss. However, weight gain is now commonly observed after initiating antiretroviral therapy (ART), particularly in individuals underweight at baseline. It remains unclear whether this weight gain reflects a "return to health" or results from drug-related or metabolic effects, and whether it persists beyond immune restoration. Recent evidence indicates that ART regimens containing second-generation integrase strand transfer inhibitors (INSTIs), such as bictegravir combined with tenofovir alafenamide, are associated with greater weight gain compared to other antiretroviral combinations, raising concerns about potential long-term metabolic consequences.Objective:To evaluate the effectiveness, safety, and tolerability of Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF) compared with Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) in ART-naïve people living with HIV (PWH) who are overweight or obese.Materials and Methods:This open-label, randomized clinical trial, approved by the Ethics and Scientific Research Committee (No. 3502), will be conducted at the Infectious Diseases Hospital of the National Medical Center "La Raza" from May 2025 to May 2027. ART-naïve PWH, recently diagnosed, with no prior use of pre-exposure prophylaxis (PrEP) or post-exposure prophylaxis (PEP), who do not require hospitalization, and have a body mass index (BMI) ≥25 kg/m² and body fat >20%, will be invited to participate. Participants will provide written informed consent and be randomized 1:1 to receive either DOR/3TC/TDF or BIC/FTC/TAF.Read full original descriptionShow less
Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate COmpared With Bictegravir/Emtricitabine/Tenofovir Alafenamide in ART-Naïve People Living With HIV and Overweight or Obesity
Background:Historically, HIV infection was associated with significant weight loss. However, weight gain is now commonly observed after initiating antiretroviral therapy (ART), particularly in individuals underweight at baseline. It remains unclear whether this weight gain reflects a "return to health" or results from drug-related or metabolic effects, and whether it persists beyond immune restoration. Recent evidence indicates that ART regimens containing second-generation integrase strand transfer inhibitors (INSTIs), such as bictegravir combined with tenofovir alafenamide, are associated with greater weight gain compared to other antiretroviral combinations, raising concerns about potential long-term metabolic consequences.Objective:To evaluate the effectiveness, safety, and tolerability of Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF) compared with Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) in ART-naïve people living with HIV (PWH) who are overweight or obese.Materials and Methods:This open-label, randomized clinical trial, approved by the Ethics and Scientific Research Committee (No. 3502), will be conducted at the Infectious Diseases Hospital of the National Medical Center "La Raza" from May 2025 to May 2027. ART-naïve PWH, recently diagnosed, with no prior use of pre-exposure prophylaxis (PrEP) or post-exposure prophylaxis (PEP), who do not require hospitalization, and have a body mass index (BMI) ≥25 kg/m² and body fat >20%, will be invited to participate. Participants will provide written informed consent and be randomized 1:1 to receive either DOR/3TC/TDF or BIC/FTC/TAF.
Inclusion: Adults (≥18 years) with confirmed HIV diagnosis, ART-naïve; Signed informed consent; HIV-1 RNA ≥1000 copies/mL; No history of PrEP or PEP failure; BMI ≥25 kg/m² and body fat >20%; Stable treatment for dyslipidemia (if applicable); No planned medication changes affecting weight; Willingness to adhere to assigned ART; Recent HIV-1 RNA and CD4+ results; GFR (CKD-EPItip) ≥60 mL/min; ALT and AST <90 IU/L; Willingness to report dietary or physical activity changes during follow-up Non-Inclusion Criteria; Uncontrolled diabetes 2. Recent changes in insulin or hypoglycemic drugs (<3 months) 3. Active malignancy 4. History of bariatric surgery 5. Allergies to study drugs 6. Hepatitis B and/or C coinfection 7. GFR <60 mL/min (CKD-EPI) 8. Drug interactions with ART regimens 9. Recent (60 days) use of anorectic drugs 10. Recent (30 days) hospitalization for severe illness 11. Unstable hypothyroidism.
Exclusion: Initiation or discontinuation of medications affecting weight after enrollment; Unplanned bariatric surgery; Newly discovered allergy to study drugs; Hepatitis B or C infection acquired during follow-up; Use of psychiatric or thyroid medications without a stable dose for ≥12 weeks; Loss of social security coverage; Withdrawal of consent.