NCT07031063 Safety, Tolerability and Effectiveness of DTG/3TC vs BIC/TAF/FTC in PWH Without Antiretroviral Experience
| NCT ID | NCT07031063 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Instituto Mexicano del Seguro Social |
| Condition | HIV Infection |
| Study Type | INTERVENTIONAL |
| Enrollment | 124 participants |
| Start Date | 2025-04-01 |
| Primary Completion | 2026-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 124 participants in total. It began in 2025-04-01 with a primary completion date of 2026-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Men and women ≥18 years of age , diagnosed with HIV, and naive to antiretroviral treatment. 2. HIV-1 RNA quantified by RT-PCR ≥500 and less than 500,000 copies/mL. 3. No history of PrEP or PEP use. 4. Estimated glomerular filtration rate ≥30 mL/min/1.73 m2 SC. 5. No current or planned use of medications associated with significant weight changes during the study period. 6. Be a beneficiary of the Mexican Social Security Institute treated at the Infectious Diseases Hospital, La Raza National Medical Center. 7. Willingness of the participant to give consent. Exclusion Criteria: 1. Diagnosis of metabolic syndrome. 2. uncontrolled diabetes 3. Contraindication to the use of INSTIs. 4. Known mutations in any of the components of either regimen (second-generation INSTIs, 3TC/FTC, or TAF). 5. Co-medications that have potential interactions with any of the components of the antiretroviral regimens. 6. Coinfection with hepatitis B or hepatitis C virus. 7. High cardiovascular risk (Framinham \>20% or AHA/ACC \>7.5%). 8. Use of recreational drugs with anorexigenic potential (crystal, methamphetamines, cocaine) 60 days prior to randomization. 9. Hospitalization for acute or severe illness 30 days prior to randomization
Contact & Investigator
José A Mata, Master degree
PRINCIPAL INVESTIGATOR
Instituto Mexicano del Seguro Social
Frequently Asked Questions
Who can join the NCT07031063 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying HIV Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07031063 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07031063 currently recruiting?
Yes, NCT07031063 is actively recruiting participants. Contact the research team at jamatamarin@gmail.com for enrollment information.
Where is the NCT07031063 trial being conducted?
This trial is being conducted at Mexico City, Mexico.
Who is sponsoring the NCT07031063 clinical trial?
NCT07031063 is sponsored by Instituto Mexicano del Seguro Social. The principal investigator is José A Mata, Master degree at Instituto Mexicano del Seguro Social. The trial plans to enroll 124 participants.
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