DOR/TDF/3TC Maintenance Therapy Among Patients Harboring M184V/I Mutation: a Pilot Open-label Study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 32
- 试验地点
- 4
- 主要终点
- Plasma HIV-RNA at 24-week
研究概览
简要总结
The goal of this pilot, phase 2, single-arm, clinical trial is to assess the antiretroviral combination Doravirine (DOR)/Lamivudine (3TC)/Tenofovir Disproxyl Fumarate (TDF) in participants with suppressed HIV who previously developed M184V/I mutation that confers resistance to 3TC. The main question it aims to answer is to explore the rate of HIV suppression 24 weeks after the switch to DOR/3TC/TDF. The study follow-up will continue until 48 weeks. Other endpoints will be metabolic changes, weight changes, modification in the HIV-DNA mutations overtime. Eligible participants will switch from their prior regimen to DOR/3TC/TDF with careful HIV-RNA monitoring.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult living with HIV
- •Receiving stable antiretroviral treatment for at least 3 months
- •HIV RNA VL<50cp/mL for at least 6 months
- •Presence of the M184V/I mutation in at least one previous genotype performed on plasma HIV RNA but absent from the genotype on current standard pro-viral DNA (Sanger technique)
- •Signed informed consent
排除标准
- •History of genotypic mutation associated with resistance to DOR or TDF according to the ANRS version 32 algorithm, i.e. :
- •For DOR : V106A/M; Y188L; G190E/S; M230L; L100I + K103N; K103N + Y181C; K103N + P225H; F227C; At least 3 amongst: A98G, L100I, K101E, V106I, E138K, Y181C/V, G190A or H221Y
- •For TDF : At least 3 mutations among: M41L, E44D, D67N, T69D/N/S, L74V/I, L210W, T215A/C/D/E/G/H/I/L/N/S/V/Y/F; K65R/E/N ; Insertion at codon 69; K70E
- •Contraindications to the use of DOR/TDF/3TC
- •Hypersensitivity to doravirine, tenofovir, lamivudine or any of the excipients (lactose in particular)
- •Current or recent treatment with a strong CYP3A4 inducer
- •Breast-feeding
- •Patients already on DOR
- •Pregnant or breast-feeding women
- •Patients under guardianship or trusteeship
研究组 & 干预措施
Single arm DOR/3TC/TDF
Doravirine 100 mg Lamivudine 300 mg Tenofovir disoproxil fumarate 245 mg Delstrigo (R): 1 pill/day for 48 weeks
干预措施: Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate 100 MG-300 MG-300 MG Oral Tablet [DELSTRIGO] (Drug)
结局指标
主要结局
Plasma HIV-RNA at 24-week
时间窗: 24 weeks from the switch to DOR/3TC/TDF
Number of copies/mL
次要结局
- Plasma HIV-RNA at 48-week(48 weeks from the switch to DOR/3TC/TDF)