NCT03275701Unknown不适用
Phase IV, Single-Arm, Open-Label Study Evaluating Bone Mineral Density in HIV-1-Infected Adults ≥50 Years Old Switching From EVG/COBI/FTC/TAF (Genvoya) or EVG/COBI/FTC/TDF (Stribild) to ABC/DTG/3TC (Triumeq)
Mills Clinical Research1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2016年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Percent change from Baseline at Week 48 in total hip BMD (measured by DEXA)
研究概览
简要总结
Phase IV, Single-Arm, Open-Label Study Evaluating Bone Mineral Density in HIV-1-Infected Adults ≥50 Years Old Switching from EVG/COBI/FTC/TAF (Genvoya) or EVG/COBI/FTC/TDF (Stribild) to ABC/DTG/3TC (Triumeq)
详细描述
Phase IV, Single-Arm, Open-Label Study Evaluating Bone Mineral Density in HIV-1-Infected Adults ≥50 Years Old Switching from EVG/COBI/FTC/TAF (Genvoya) or EVG/COBI/FTC/TDF (Stribild) to ABC/DTG/3TC (Triumeq)
To evaluate the impact on BMD, as measured by DEXA over 48 weeks, of switching from an INSTI-based regimen with either TDF or TAF to a regimen of ABC/DTG/3TC (administered as commercial Triumeq) in chronic HIV-infected patients over the age of 50
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented HIV-1 infection;
- •At least 50 years of age;
- •Currently on a stable antiretroviral regimen (for ≥3 months preceding Screening) of either EVG/COBI/FTC/TAF (Genvoya) or EVG/COBI/FTC/TDF (Stribild);
- •HIV is currently suppressed, defined as:
- •Plasma HIV-1 RNA <50 c/mL for ≥3 months preceding Screening; AND
- •Plasma HIV-1 RNA <50 copies/mL at the Screening assessment; INCL
- •Documentation that the participant is negative for the human leukocyte antigen (HLA)-B*5701 allele.
排除标准
- •Pregnant, breastfeeding, or planning to become pregnant during the study period;
- •Bilateral hip replacement;
- •Exceeds weight limit for DEXA equipment (i.e., weighs >350 lbs or >159 kg);
- •History or presence of allergy to the study treatment (Triumeq) or any of its components (to ABC, DTG, or 3TC);
- •Active Centers for Disease Control and Prevention (CDC) Category C HIV-1 disease (see Section 17.1 for definition), with the exception of cutaneous Kaposi's sarcoma, not requiring systemic therapy and historic CD4+ cell counts of <200 cells/mm3;
- •Positive for hepatitis B virus surface antigen (HBsAg) at Screening;
- •Ongoing malignancies (other than localized malignancies, such as cutaneous Kaposi's sarcoma, basal cell carcinoma, cervical intraepithelial neoplasia);
- •Significant suicidal risk in the investigator's opinion;
- •Metabolic disease;
- •Treatment with HIV immunotherapeutic vaccine within 90 days of Screening;
- •Radiation, cytotoxic chemotherapy, or any immunomodulator (that alters immune responses) within 28 days of Screening;
- •Exposure to any experimental drug or vaccine within 28 days or 5 half-lives of the test agent, or twice the duration of the biological effect of the test agent, whichever is longer, prior to first dose of study treatment on Day 1;
- •History of use of only mono or dual NRTI therapy prior to starting combination ART for the treatment of HIV infection (except that prior NRTI use for the purpose of pre-exposure prophylaxis [PrEP] or postexposure prophylaxis [PEP] is not excluded);
- •Became HIV-positive (i.e., had a detectable plasma HIV-1 viral load) while taking PrEP or PEP;
- •Documented resistance to any component of the study treatment (ABC, DTG, or 3TC) as indicated by either:
- •Historical genotype in the participant's medical record; OR
- •Genotype obtained by GenoSure Archive evaluation at Screening;
- •Any verified screening Grade 4 laboratory abnormality that in the investigator's opinion is clinically significant;
- •Moderate to severe hepatic impairment (Class B or greater) as determined by Child-Pugh classification;
- •Either of the following liver chemistry elevations:
- •Alanine amintotransferase (ALT) ≥5 x the upper limit of normal (ULN); OR
- •ALT ≥3 x ULN and bilirubin ≥1.5 x ULN (with >35% direct bilirubin);
- •Creatinine clearance (CrCl) of <50 mL/min (calculated by CockroftGault equation)
- •QT interval corrected for heart rate according to Bazett's formula (QTcB) ≥450 msec or QTcB ≥480 msec for participants with bundle branch block;
- •Any other condition or substance use that in the opinion of the investigator places the participants at undue risk from participation in the study or that may negatively impact the integrity of the study analyses.
研究组 & 干预措施
Triumeq
Other
Single Arm, Open Label
干预措施: Triumeq (Drug)
结局指标
主要结局
Percent change from Baseline at Week 48 in total hip BMD (measured by DEXA)
时间窗: 48 Weeks
Percent change from Baseline at Week 48 in lumbar spine BMD (measured by DEXA)
时间窗: 48 Weeks
次要结局
未报告次要终点
研究者
Anthony Mills MD
Clinical Research Director
Mills Clinical Research
研究点 (1)
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