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Compares treatment options for HIV - Human Immunodeficiency Virus
Official title DOR/TDF/3TC COmpared With BIC/FTC/TAF in ART-Naïve People Living With HIV and Overweight or Obesity
ClinicalTrials.gov ID: NCT07075146
What this study is testing
What is DOR/3TC/TDF?
DOR/3TC/TDF is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for hiv - human immunodeficiency virus.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 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%
You likely can't join if
- Loss of social security coverage
- Newly discovered allergy to study drugs
- Withdrawal of consent
- Hepatitis B or C infection acquired during follow-up
- Use of psychiatric or thyroid medications without a stable dose for ≥12 weeks
- Initiation or discontinuation of medications affecting weight after enrollment
See the full eligibility criteria
- 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-1\. Uncontrolled diabetes 2. Recent changes in insulin or hypoglycemic drugs (\<3 months) 3. Active malignancy 4. History of bariatric...
- Loss of social security coverage
- Newly discovered allergy to study drugs
- Withdrawal of consent
- Hepatitis B or C infection acquired during follow-up
- Use of psychiatric or thyroid medications without a stable dose for ≥12 weeks
- Initiation or discontinuation of medications affecting weight after enrollment
- Unplanned bariatric surgery
The study team makes the final eligibility decision.
Where it's taking place
- Mexico City, Mexico
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Mexico City, Mexico. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.