Efficacy, Safety, and Tolerability of Switching to a Two-Drug Regimen With DTG/3TC Compared to Maintaining a Three-Drug Regimen With BIC/FTC/TAF or DTG/3TC/ABC in Virologically Suppressed PeopLe Living With HIV After 24 and 48 Weeks of Follow-Up
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 156
- 试验地点
- 1
- 主要终点
- Effectiveness.
研究概览
简要总结
This is a phase 4, randomized, controlled, open-label, single-center clinical trial conducted at the Hospital de Infectología, National Medical Center "La Raza." The study employs a non-inferiority design with follow-up assessments at 24 and 48 weeks. The study will enroll 156 PLWH aged ≥18 years who are on ART with BIC/FTC/TAF or DTG/3TC/ABC and have maintained virological suppression (HIV-1 RNA <50 copies/mL) for at least 48 weeks. Participants will be randomized in a 2:1 ratio: 104 to switch to DTG/3TC and 52 to continue their current regimen (control group).
详细描述
Since the identification of the human immunodeficiency virus (HIV), developing effective, safe, and well-tolerated antiretroviral therapy (ART) for people living with HIV (PLWH) has been a global health priority. Advances in ART have significantly improved the prognosis for PLWH, achieving life expectancies comparable to the general population. However, three-drug regimens, such as bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) or dolutegravir/lamivudine/abacavir (DTG/3TC/ABC), are associated with metabolic, renal, and cardiovascular adverse effects, particularly in the Mexican population, which has a high prevalence of metabolic syndrome.
Clinical trials, including GEMINI, TANGO, SALSA, RUMBA, PASO DOBLE, and DYAD, have demonstrated that two-drug regimens, such as dolutegravir/lamivudine (DTG/3TC), offer comparable virological efficacy and improved tolerability. Reducing the pharmacological burden may minimize adverse effects while maintaining viral suppression. The impact of metabolic disturbances on fat weight gain remains a controversial issue.
Objectives General Objective To compare the effectiveness, safety, and tolerability of switching to a DTG/3TC regimen versus continuing BIC/FTC/TAF or DTG/3TC/ABC in virally suppressed PLWH at 24 and 48 weeks of treatment.
Secondary Objectives
- Assess changes in lipid profile, body mass index (BMI), and abdominal circumference.
- Evaluate alterations in glucose metabolism.
- Measure changes in blood pressure and cardiovascular risk using Framingham and AHA/ACC scales.
- Analyze changes in body composition (fat, water, muscle).
- Document adverse events associated with ART. Study Design This is a phase 4, randomized, controlled, open-label, single-center clinical trial conducted at the Hospital de Infectología, National Medical Center "La Raza." The study employs a non-inferiority design with follow-up assessments at 24 and 48 weeks. The study will enroll 156 PLWH aged ≥18 years who are on ART with BIC/FTC/TAF or DTG/3TC/ABC and have maintained virological suppression (HIV-1 RNA <50 copies/mL) for at least 48 weeks. Participants will be randomized in a 2:1 ratio: 104 to switch to DTG/3TC and 52 to continue their current regimen (control group).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •PLWH aged over 18 years.
- •Virologically suppressed for at least 48 weeks prior to study enrollment.
- •On ART with Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) or Dolutegravir/Lamivudine/Abacavir (DTG/3TC/ABC).
- •No history of virologic failure.
- •Willing to participate in the study.
- •Signed written informed consent.
- •HIV-1 RNA <50 copies/mL within 4 weeks prior to randomization.
- •eGFR by CKD-EPI ≥60 mL/min.
排除标准
- •Pregnant or breastfeeding patients.
- •Known allergies to any component of the antiretroviral regimens.
- •Coinfection with hepatitis B and/or hepatitis C virus.
- •Concomitant medications that interact with any component of the ART regimens.
- •Diagnosis of malignancy prior to randomization.
- •Use of recreational drugs with anorexigenic potential (crystal meth, methamphetamines, cocaine) within 60 days prior to randomization.
研究组 & 干预措施
Standar therapy
Bictegravir 50 mg / tenofovir alafenamide 25 mg / emtricitabine 200 mg or dolutegravir 50 mg / lamivudine 300 mg / abacavir 600 mg, both combinations in a single tablet, will be used as standard therapy
干预措施: Standard Medical Therapy (Drug)
dual therapy
This arm is the experimental one, with dual therapy, 2 drugs: Dolutegravir 50 mg/Lamivudina 300 mg, in a single tablet.
干预措施: dual therapy (Drug)
结局指标
主要结局
Effectiveness.
时间窗: 24 and 48 weeks.
Effectiveness: Individuals with \>50 copies/ml.
Tolerability of switching ART regimen with an INSTI to DTG/3TC.
时间窗: 24 and 48 weeks.
Maintaining ART with DTG/3TC without changes, interruptions, or substitutions due to adverse effects or perceived discomfort.
Safety of switching ART regimen with an INSTI to DTG/3TC.
时间窗: 24 and 48 weeks.
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 at 24 and 48 weeks, expressed in proportions of new cases.
次要结局
- Glucose metabolism disorders.(24 and 48 weeks.)
- Measure body composition(24 and 48 weeks)
- Changes in lipid profile.(24 and 48 weeks)
- Changes in body mass index(24 and 48 weeks.)
- Changes in waist circumference.(24 and 48 weeks.)
- Assess changes in blood pressure and cardiovascular risk(24 and 48 weeks)
研究者
José Antonio Mata Marín
Doctor
Instituto Mexicano del Seguro Social