NCT07075146RecruitingPhase 3
DOR/TDF/3TC COmpared With BIC/FTC/TAF in ART-Naïve People Living With HIV and Overweight or Obesity
Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate COmpared With Bictegravir/Emtricitabine/Tenofovir Alafenamide in ART-Naïve People Living With HIV and Overweight or Obesity
Source: ClinicalTrials.gov · Last updated 24 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 306 (estimated)
- First submitted
- 28 Jun 2025
- Start date
- 5 May 2025
- Primary completion date
- 5 Jun 2026
- Lead sponsor
- José Antonio Mata Marín
- NCT number
- NCT07075146
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 306
- From 5 May 2025 to the primary completion date, 5 Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Initiation or discontinuation of medications affecting weight after enrollment
- Unplanned bariatric surgery
Other illness
- 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
Other
- Loss of social security coverage
- Withdrawal of consent
Who the study is looking for
- 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
- 1\. 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
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital de infectología, Centro Médico Nacional La Raza Coordinator of this site? Confirm its status | Mexico City | Mexico | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.