Actively Recruiting
Safety, Tolerability and Effectiveness of DTG/3TC vs BIC/TAF/FTC in PWH Without Antiretroviral Experience
Led by Instituto Mexicano del Seguro Social · Updated on 2025-06-26
124
Participants Needed
1
Research Sites
191 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Background: The primary goal of antiretroviral therapy is to prevent HIV-associated morbidity and mortality. The effectiveness of first-line regimens is supported by a large number of clinical trials; current concerns focus on the long-term adverse effects of antiretrovirals, especially integrase strand transfer inhibitors, as they have been associated with significant weight gain, which may be associated with increased cardiovascular risk. Objective: To determine the effectiveness, safety, and tolerability of Dolutegravir/Lamivudine (DTG/3TC) compared with Bictegravir/Tenofovir Alafenamide/Emtricitabine (BIC/TAF/FTC) in treatment-naive people living with HIV (PWH). Materials and methods: With prior approval from the Ethics and Scientific Research Committee 3502, an open-label, randomized clinical trial will be conducted at the Infectious Diseases Hospital of the National Medical Center "La Raza" from November 2024 to May 2026. Recently diagnosed PWH with no history of PrEP and/or PeP use, without hospitalization criteria, and without a diagnosis of metabolic syndrome based on ATP-III criteria will be identified. They will be invited to participate in the study and, if they accept, they will sign an informed consent form. They will be randomized to start a BIC/TAF/FTC or DTG/3TC 1:1 regimen. Laboratory studies, vital signs, and somatometry including bioimpedance will be performed at 4, 12, 24, 36, 48, 72, 96, 120, 144 weeks of follow-up; viral load and CD4+ count will be measured at weeks 12, 24, 48, 72, 96, 120, 144 weeks after the start of treatment. Sampling will be non-probabilistic; the distribution will be identified using the Kolmogorov-Smirnoff test, and measures of central tendency and percentages will be expressed. Comparisons will be made using the Mann-Whitney U test. Qualitative data will be analyzed using the x2 or Fisher's exact test. Group analysis will be performed at 12, 24, 48, 96 and 144 weeks using the Wilcoxon test. A P value ≤0.05 with a 95% confidence interval will be considered statistically significant.
CONDITIONS
Official Title
Safety, Tolerability and Effectiveness of DTG/3TC vs BIC/TAF/FTC in PWH Without Antiretroviral Experience
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women 18 years of age or older, diagnosed with HIV, and naive to antiretroviral treatment
- HIV-1 RNA levels between 500 and less than 500,000 copies/mL
- No history of PrEP or PEP use
- Estimated glomerular filtration rate of at least 30 mL/min/1.73 m2
- No current or planned use of medications that cause significant weight changes during the study
- Beneficiary of the Mexican Social Security Institute treated at the Infectious Diseases Hospital, La Raza National Medical Center
- Willing to provide informed consent
You will not qualify if you...
- Diagnosis of metabolic syndrome
- Uncontrolled diabetes
- Contraindication to using integrase strand transfer inhibitors (INSTIs)
- Known mutations affecting any drugs in the study regimens
- Use of medications that may interact with the study antiretroviral treatments
- Coinfection with hepatitis B or hepatitis C viruses
- High cardiovascular risk according to defined scores
- Use of recreational drugs with appetite-suppressing effects within 60 days before randomization
- Hospitalization for acute or severe illness within 30 days before randomization
AI-Screening
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Trial Site Locations
Total: 1 location
1
Hospital de infectología, Centro Médico Nacional La Raza
Mexico City, Azcapotzalco, Mexico, 02990
Actively Recruiting
Research Team
J
José A Mata, M.Sc.
CONTACT
A
Ana L Cano, Posgraduate
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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