DOR/TDF/3TC COmpared With BIC/FTC/TAF in ART-Naïve People Living With HIV and Overweight or Obesity
Recruiting
Phase 3
Interventional Study
HIV - Human Immunodeficiency Virus
Obesity
Overweight and/or Obesity
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 70
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 306 (estimated)
- Sponsor
- José Antonio Mata Marín · Government
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About This Trial
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 restora…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Adults (≥18 years) with confirmed HIV diagnosis, ART-naïve
2. Signed informed consent
3. HIV-1 RNA ≥1000 copies/mL
4. No history of PrEP or PEP failure
5. BMI ≥25 kg/m² and body fat \>20%
6. Stable treatment for dyslipidemia (if applicable)
7. No planned medication changes af…
Contacts