Perturbing of HIV Reservoir With Immune Stimulation
Perturbing the HIV Reservoir With Immune Stimulation
研究概览
详细说明
Title: Perturbing the HIV Reservoir
Sample Size: 56
Study Population: HIV-infected individuals between 18 and 65 years old who started similar antiretroviral therapy (ART) during chronic infection and remained virally suppressed for at least 48 weeks before enrollment. Participants will have CD4 >250 cells/μl at enrollment and a CD4 nadir >100 cells/μl.
Participating Sites: UCSD's Antiviral Research Center (AVRC)
Study Design: The proposed study is a randomized double-blinded control trial conducted over 28 weeks. Randomized interventions will be injections of Influenza vaccine, Pneumococcal vaccine, and Placebo. Each participant will receive each injection but in a randomized order.
Schedule of Evaluations: Study evaluations will be based on three 30 day cycles (Influenza vaccine, Pneumococcus vaccine, Placebo in random order) over 28 weeks of the RCT. Pre injection: one paired blood and genital secretion sample will be collected before each injection. Post-injection: paired blood and genital secretion samples will be collected on days 2, 4, 7, 14 and 30 after each injection.
Study Duration: 240 weeks
Study Regimen/Intervention: This is a double blind RCT of two vaccines (Pneumovax®23 and Fluarix®) plus placebo (sterile saline injection). Study participants will be followed for 28 weeks after enrollment. During this 28-week period, blood and genital secretion samples will be collected on day 0 and five subsequent time points after each injection (days 2, 4, 7, 14 and 30). Injections (vaccine or placebo) will be administered 12 weeks apart and in a random order, to minimize a possible bias due to the order of the vaccines.
Primary Objective: To determine the impact of Pneumococcus and Influenza vaccines on the HIV transcriptional activity in individuals who are virologically suppressed for at least 48 weeks on similar ART.
Primary Outcome: Average level of CD4+ T cell-associated HIV RNA transcription measured at days 2, 4, 7, 14 and 30 after each injection.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
California
-
San Diego、California、美国、92103-8208
- UCSD AntiViral Research Center (AVRC)
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria
- Documented HIV-1 infection more than 365 days ago (HIV antibody or viral load positive).
- Capable of signing written informed consent.
- Documented viral s suppression for at least 48 weeks (≤50 copies/mL)
- Men and women between 18 and 65 years of age.
- Read and comprehend English.
- Documented CD4 count at enrollment (>250 cells/µl)
- Reported CD4 nadir >100 cells/µl.
- Received seasonal flu vaccination at least 6 weeks prior to first trial injection (and not more recently)
- Received vaccination for pneumococcal disease at least 12 months prior to first trial injection (and not more recently)
- Started ART during chronic infection (> 6 months from estimated date of injection)
Exclusion Criteria
- Uncontrolled psychiatric condition.
- Under the influence of drug(s) or alcohol at time of screening.
- Any condition that, in the opinion of the investigator, would limit follow-up and adequate consent.
- History of allergic reactions to any of the proposed vaccines or egg allergy.
- History of Gullian Barre syndrome
- Receiving immunosuppressive medications.
- Pregnancy or lactation.
学习计划
研究是如何设计的？
设计细节
- 主要用途：基础科学
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
其他：Pneumococcal, then Influenza, then Placebo vaccination
Participants first received a 0.5 mL injection of Pneumococcal vaccine (Pneumovax-23®).
After a washout period of at least 6 weeks, they then received a 0.5 mL injection of Influenza vaccine (Fluarix®, GSK).
After another washout period of at least 6 weeks, the participant received a 0.5 mL injection of saline (placebo).
|
Intramuscular injection with Fluarix® .
Intramuscular injection with Pneumovax.
Intramuscular injection with sterile saline (placebo).
|
|
其他：Pneumococcal, then Placebo, then Influenza vaccination
Participants first received a 0.5 mL injection of Pneumococcal vaccine (Pneumovax-23®).
After a washout period of at least 6 weeks, they then received a 0.5 mL injection of saline (placebo).
After another washout period of at least 6 weeks, the participant received a 0.5 mL injection of Influenza vaccine (Fluarix®, GSK).
|
Intramuscular injection with Fluarix® .
Intramuscular injection with Pneumovax.
Intramuscular injection with sterile saline (placebo).
|
|
其他：Influenza, then Pneumococcal, then Placebo vaccination
Participants first received a 0.5 mL injection of Influenza vaccine (Fluarix®, GSK).
After a washout period of at least 6 weeks, they then received a 0.5 mL injection of Pneumococcal vaccine (Pneumovax-23®).
After another washout period of at least 6 weeks, the participant received a 0.5 mL injection of saline (placebo).
|
Intramuscular injection with Fluarix® .
Intramuscular injection with Pneumovax.
Intramuscular injection with sterile saline (placebo).
|
|
其他：Influenza, then Placebo, then Pneumococcal vaccination
Participants first received a 0.5 mL injection of Influenza vaccine (Fluarix®, GSK).
After a washout period of at least 6 weeks, they then received a 0.5 mL injection of saline (placebo).
After another washout period of at least 6 weeks, the participant received a 0.5 mL injection of Pneumococcal vaccine (Pneumovax-23®).
|
Intramuscular injection with Fluarix® .
Intramuscular injection with Pneumovax.
Intramuscular injection with sterile saline (placebo).
|
|
其他：Placebo, then Pneumococcal, then Influenza vaccination
Participants first received a 0.5 mL injection of saline (placebo).
After a washout period of at least 6 weeks, they then received a 0.5 mL injection of Pneumococcal vaccine (Pneumovax-23®).
After another washout period of at least 6 weeks, the participant received a 0.5 mL injection of Influenza vaccine (Fluarix®, GSK).
|
Intramuscular injection with Fluarix® .
Intramuscular injection with Pneumovax.
Intramuscular injection with sterile saline (placebo).
|
|
其他：Placebo, then Influenza, then Pneumococcal vaccination
Participants first received a 0.5 mL injection of saline (placebo).
After a washout period of at least 6 weeks, they then received a 0.5 mL injection of Influenza vaccine (Fluarix®, GSK).
After another washout period of at least 6 weeks, the participant received a 0.5 mL injection of Pneumococcal vaccine (Pneumovax-23®).
|
Intramuscular injection with Fluarix® .
Intramuscular injection with Pneumovax.
Intramuscular injection with sterile saline (placebo).
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change From Vaccination (Day 0) in Mean CD4+ T Cell-associated HIV RNA Transcription at Day 7
大体时间：Day 0 and Day 7
|
CD4+ T cell-associated HIV RNA was measured before vaccination on Day 0 and again on Day 7. The Day-0 measure of CD4+ T cell-associated HIV RNA transcription was subtracted from the Day-7 measure.
|
Day 0 and Day 7
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 160089
- 1R01AI118422-01A1 (美国 NIH 拨款/合同)
计划个人参与者数据 (IPD)
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