NCT00212888已完成1 期
A Pilot Study to Determine the Impact of Therapeutic HIV Vaccination Followed by a Scheduled Interruption of Antiretroviral Therapy on HIV-Specific Immune Function and Virologic Rebound in Patients With Prolonged Viral Suppression
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 6
- 主要终点
- Time to Detectable Virus in the Remune Plus ALVAC Group and the Placebo Group
研究概览
简要总结
The purpose of this study is to determine if vaccination before a structured treatment interruption (STI) is associated with an improvement in immune function, resulting in a delayed and reduced rebound in the amount of HIV virus in the blood.
详细描述
Volunteers will be randomly assigned to receive the vaccines or matching placebos before interrupting their antiretroviral therapy at week 24.
Dosage:
Remune(TM) 1 ml i.m.* at weeks 0, 12, and 20; ALVAC 1 ml i.m.* at weeks 8,12, 16, and 20.
* i.m.: injected in a muscle
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •Documented HIV infection (by serology)
- •HIV RNA level below 50 copies/ml for at least two years
- •Receiving at least 2 antiretroviral agents including at least 1 protease inhibitor or 1 non-nucleoside reverse transcriptase inhibitor at time of screening
- •Have CD4 counts above 500 cells/ul
- •Have CD4/CD8 ratio above 0.5
- •Have never had a CD4 count below 250
- •No previous AIDS-defining opportunistic infection
- •No previous cancer chemotherapy or other system immunosuppressive therapy (excluding brief courses [<= 1 month] of prednisone or its equivalent)
- •Able to provide informed consent
排除标准
- •Hepatitis B surface antigen positive
- •Hepatitis C antibody positive
- •AST, ALT, ALP, creatinine, urea above three times the normal upper limit
- •Blood abnormalities (hemoglobin lower than 100, white blood cell count [WBC] lower than 1500 or platelets lower than 100)
- •Allergies to components of Remune™ or ALVAC
- •Contraindications to vaccine components
- •Pregnancy or breastfeeding
结局指标
主要结局
Time to Detectable Virus in the Remune Plus ALVAC Group and the Placebo Group
时间窗: Up to week 48
次要结局
- Time to Rebound of Plasma HIV RNA Level to 10,000 Copies/ml(Up to week 48)
- Viral Set-point(Up to week 48)
- Magnitude of Viral Rebound(Up to week 48)
- HIV-specific Immune Function(at week 48)
- Time to Detectable Virus in the ALVAC Alone Group and the Placebo Group(Up to week 48)
研究者
研究点 (6)
Loading locations...
相似试验
已完成
不适用
The impact of therapeutic Human Immunodeficiency Virus (HIV) vaccination followed by antiretroviral therapy in patients with prolonged viral suppressioHuman Immunodeficiency Virus (HIV)Infections and InfestationsHuman immunodeficiency virus (HIV)ISRCTN87061665Ottawa Hospital Research Institute (Canada)60
已完成
1 期
A Pilot Study of Glioma Associated Antigen Vaccines in Conjunction with Poly-ICLC in Pediatric GliomasNewly Diagnosed Pediatric Pontine GliomaNewly Diagnosed Pediatric High Grade GliomaRecurrent Pediatric High Grade GliomaRecurrent Pediatric Low Grade GliomaNCT01130077James Felker60
已完成
1 期
Vaccine Therapy and Basiliximab in Treating Patients With Acute Myeloid Leukemia in Complete RemissionAdult Acute Myeloid Leukemia in RemissionAdult Acute Myeloid Leukemia With 11q23 (MLL) AbnormalitiesAdult Acute Myeloid Leukemia With Del(5q)Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)NCT01842139University of Chicago7
已完成
1 期
Trial to Evaluate the Safety and Immunogenicity of Priming Regimens of 426c.Mod.Core-C4b and Optional Boost Regimen With HIV Trimer BG505 SOSIP.GT1.1 gp140, Both Adjuvanted With 3M-052-AF + Alum in Healthy, Adult Participants Without HIVHIV-1-infectionNCT05471076National Institute of Allergy and Infectious Diseases (NIAID)52
已完成
1 期
Study Evaluating Vaccine in Adults With HIVHIV InfectionsNCT00195234Wyeth is now a wholly owned subsidiary of Pfizer60