Perturbing of HIV Reservoir With Immune Stimulation
Perturbing the HIV Reservoir With Immune Stimulation
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
California
-
San Diego、California、アメリカ、92103-8208
- UCSD AntiViral Research Center (AVRC)
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：基礎科学
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
他の：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).
|
|
他の：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).
|
|
他の：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).
|
|
他の：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).
|
|
他の：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).
|
|
他の：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).
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change From Vaccination (Day 0) in Mean CD4+ T Cell-associated HIV RNA Transcription at Day 7
時間枠：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
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- 160089
- 1R01AI118422-01A1 (米国 NIH グラント/契約)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
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