Implementation and Evaluation of an HIV-2 Viral Load and ARV Resistance Informed Algorithm for 2nd-line ART in HIV-2 Infected Patients in the Initiative Sénégalaise d'Accès Aux Antirétroviraux (ISAARV) Program
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 152
- 试验地点
- 2
- 主要终点
- Loss to follow up
研究概览
简要总结
Prospective, longitudinal, open label, HIV-2 viral load and antiretroviral resistance informed 2nd-line ARV implementation study.
详细描述
Prospective, longitudinal, open label, HIV-2 viral load and antiretroviral resistance informed 2nd-line ARV implementation study.
DURATION
Up to 3 years
SAMPLE SIZE
150
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV-2 infection: confirmed by Determine (Alere, Inc.) & Immunocomb II (Alere, Inc.) or equivalent
- •Failing 1st line antiretroviral therapy (e.g. AZT/3TC or TDF/XTC + LPV/r; previous 3 NRTI or 2 NRTI regimens; previous Indinavir (IDV) use, current or previous Atazanavir (ATV) use; previous NNRTI use)
- •For females of reproductive potential: negative serum or urine pregnancy test
- •Men and women age >/=18 years
- •Ability and willingness of subject to provide informed consent
排除标准
- •HIV-1 or HIV-1/HIV-2 dual infection
- •Pregnancy or Breast-feeding
- •Lab Abnormalities
- •AST/ALT >2.5 X ULN
- •CrCl <30
- •Current or previous use of Integrase Inhibitors or Darunavir
研究组 & 干预措施
No HIV-2 resistance
干预措施: HIV-2 Genotypic Drug Resistance Testing using DBS (Diagnostic Test)
No HIV-2 resistance
干预措施: 2nd line ART ( Zidovudine 300mg BID + Lamivudine 150mg BID or Tenofovir DF 300mg QD + Lamividine 300mg QD or Emtricitabine 200mg QD + Lopinavir/Ritonavir 400/100mg BID) (Drug)
HIV-2 NRTI resistance only
干预措施: HIV-2 Genotypic Drug Resistance Testing using DBS (Diagnostic Test)
HIV-2 NRTI resistance only
干预措施: 2nd line ART (Tenofovir DF 300mg QD + Lamividine 300mg QD or Emtricitabine 200mg QD + Lopinavir/Ritonavir 400/100mg BID + Raltegravir 400mg BID ) (Drug)
HIV-2 NRTI and PI resistance
干预措施: HIV-2 Genotypic Drug Resistance Testing using DBS (Diagnostic Test)
HIV-2 NRTI and PI resistance
干预措施: 2nd line ART (Tenofovir DF 300mg QD + Lamividine 300mg QD or Tenofovir DF 300mg QD + Emtricitabine 200mg QD + Darunavir 600mg BID-Ritonavir 100mg BID +Raltegravir 400mg BID) (Drug)
结局指标
主要结局
Loss to follow up
时间窗: 1 year
no contact with study for 1 year
Virologic Failure on 2nd line ART
时间窗: up to 3 years
VL \>250 copies/ml
HIV-2 ARV resistance on 2nd line ART
时间窗: up to 3 years
by DBS genotyping
Death
时间窗: up to 3 years
all cause mortality
次要结局
- New WHO stage 3 or 4 event > 6 months after starting ART(up to 3 years)
- Grade 3 or 4 adverse events(up to 3 years)
- CD4 T-cell count trajectory(up to 3 year after starting 2nd-line ART)
研究者
Geoffrey S. Gottlieb
Professor
University of Washington