Safety, Tolerability and Effectiveness of DTG/3TC vs BIC/TAF/FTC in PWH Without Antiretroviral Experience
TEOTL
1 other identifier
interventional
124
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Apr 2025
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2025
CompletedFirst Submitted
Initial submission to the registry
May 25, 2025
CompletedFirst Posted
Study publicly available on registry
June 22, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2028
June 26, 2025
June 1, 2025
1.7 years
May 25, 2025
June 21, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
To determine the effectiveness of Dolutegravir/Lamivudine compared with Bictegravir/Tenofovir Alafenamide/Emtricitabine in ART-naive people with HIV at 144 weeks of treatment.
-Effectiveness: Number of participants with viral load measurement (HIV-1 RNA) \<50 copies/mL at 144 weeks of follow-up for PWH treated with DTG/3TC or BIC/FTC/TAF, expressed in proportions.
144 weeks of follow-up with interim analysis at 48 and 96 weeks
To determine the safety of Dolutegravir/Lamivudine compared with Bictegravir/Tenofovir Alafenamide/Emtricitabine in ART-naive people living with HIV at 144 weeks of treatment.
Number of participants with treatment-related adverse events as assessed of serious adverse events (WHO grade 3 or 4) for PWH treated with DTG/3TC or BIC/FTC/TAF at 144 weeks, expressed in proportions of new cases.
144 weeks, with intermediate measurements at 48 and 96 weeks
To determine the tolerability of Dolutegravir/Lamivudine compared with Bictegravir/Tenofovir Alafenamide/Emtricitabine in ART-naive people living with HIV at 144 weeks of treatment.
Number of participants with secondary events associated with ART for PWH treated with DTG/3TC or BIC/FTC/TAF at 144 weeks expressed in proportions and percentages, graded from 1 to 4 according to DAIDS: Grade I: mild Grade II: moderate Grade III: severe Grade IV: life-threatening
144 weeks, intermediate measurements at 48 and 96 weeks
Secondary Outcomes (5)
Metabolic syndrome incidence in DTG/3TC vs BIC/TAF/FTC at 144 weeks
144 weeks, interim analyses at 48 and 96 weeks
To evaluate changes in cardiovascular risk based on AHA/ACC score in ART-naive PWH starting a regimen with DTG/3TC compared with BIC/FTC/TAF after 144 weeks of follow-up.
144 weeks, with interim analyses at 48 and 96 weeks
To determine the incidence of overweight/obesity in ART-naive PWH initiating a DTG/3TC regimen compared with BIC/FTC/TAF after 144 weeks of follow-up.
144 weeks, with interim analyses at 48 and 96 weeks
To determine significant weight changes in ART-naive PWH initiating a DTG/3TC regimen compared with BIC/FTC/TAF after 144 weeks of follow-up.
144 weeks, with interim analyses at 48 and 96 weeks
To determine the incidence of virologic failure in ART-naive in PWH treated with DTG/3TC compared with BIC/TAF/FTC at 144 weeks of follow-up
144 weeks, with intermediate measurements at 48 and 96 weeks
Study Arms (2)
BIC/TAF/FTC
ACTIVE COMPARATORBictegravir/ tenofovir alafenamide/ emtricitabine 50/ 25/ 200 mg. It is the usual therapy, consisting of 3 drugs in a single tablet, based on an integrase inhibitor, and 2 nucleoside analogues.
DTG/3TC
EXPERIMENTALDolutegravir/lamivudine 50/300 mg. 2-drug therapy in 1 tablet, co-formulated with 1 integrase inhibitor and 1 nucleoside analogue
Interventions
Dual therapy of 2 drugs co-formulated in 1 tablet: Dolutegravir 50 mg/ lamivudine 300 mg, it is the experimental group
It is a triple-drug antiretroviral drug co-formulated in a single tablet. It contains bictegravir 50 mg, tenofovir alafenamide 25 mg, and emtricitabine 200 mg. It is the standard therapy.
Eligibility Criteria
You may qualify if:
- Men and women ≥18 years of age , diagnosed with HIV, and naive to antiretroviral treatment.
- HIV-1 RNA quantified by RT-PCR ≥500 and less than 500,000 copies/mL.
- No history of PrEP or PEP use.
- Estimated glomerular filtration rate ≥30 mL/min/1.73 m2 SC.
- No current or planned use of medications associated with significant weight changes during the study period.
- Be a beneficiary of the Mexican Social Security Institute treated at the Infectious Diseases Hospital, La Raza National Medical Center.
- Willingness of the participant to give consent.
You may not qualify if:
- Diagnosis of metabolic syndrome.
- uncontrolled diabetes
- Contraindication to the use of INSTIs.
- Known mutations in any of the components of either regimen (second-generation INSTIs, 3TC/FTC, or TAF).
- Co-medications that have potential interactions with any of the components of the antiretroviral regimens.
- Coinfection with hepatitis B or hepatitis C virus.
- High cardiovascular risk (Framinham \>20% or AHA/ACC \>7.5%).
- Use of recreational drugs with anorexigenic potential (crystal, methamphetamines, cocaine) 60 days prior to randomization.
- Hospitalization for acute or severe illness 30 days prior to randomization
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital de infectología, Centro Médico Nacional La Raza
Mexico City, Azcapotzalco, 02990, Mexico
Related Publications (4)
Gallant J, Lazzarin A, Mills A, Orkin C, Podzamczer D, Tebas P, Girard PM, Brar I, Daar ES, Wohl D, Rockstroh J, Wei X, Custodio J, White K, Martin H, Cheng A, Quirk E. Bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection (GS-US-380-1489): a double-blind, multicentre, phase 3, randomised controlled non-inferiority trial. Lancet. 2017 Nov 4;390(10107):2063-2072. doi: 10.1016/S0140-6736(17)32299-7. Epub 2017 Aug 31.
PMID: 28867497BACKGROUNDDurable Efficacy of Dolutegravir Plus Lamivudine in Antiretroviral Treatment-Naive Adults With HIV-1 Infection: 96-Week Results From the GEMINI-1 and GEMINI-2 Randomized Clinical Trials: Erratum. J Acquir Immune Defic Syndr. 2020 Jul 1;84(3):e21. doi: 10.1097/QAI.0000000000002394.
PMID: 32530908BACKGROUNDCahn P, Madero JS, Arribas JR, Antinori A, Ortiz R, Clarke AE, Hung CC, Rockstroh JK, Girard PM, Sievers J, Man C, Currie A, Underwood M, Tenorio AR, Pappa K, Wynne B, Fettiplace A, Gartland M, Aboud M, Smith K; GEMINI Study Team. Dolutegravir plus lamivudine versus dolutegravir plus tenofovir disoproxil fumarate and emtricitabine in antiretroviral-naive adults with HIV-1 infection (GEMINI-1 and GEMINI-2): week 48 results from two multicentre, double-blind, randomised, non-inferiority, phase 3 trials. Lancet. 2019 Jan 12;393(10167):143-155. doi: 10.1016/S0140-6736(18)32462-0. Epub 2018 Nov 9.
PMID: 30420123BACKGROUNDKelly SG, Nyaku AN, Taiwo BO. Two-Drug Treatment Approaches in HIV: Finally Getting Somewhere? Drugs. 2016 Apr;76(5):523-31. doi: 10.1007/s40265-016-0553-8.
PMID: 26886135BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
José A Mata, Master degree
Instituto Mexicano del Seguro Social
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr. José Antonio Mata Marín
Study Record Dates
First Submitted
May 25, 2025
First Posted
June 22, 2025
Study Start
April 1, 2025
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2028
Last Updated
June 26, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share
Participant data are confidential and may be requested from the principal investigator.