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Perturbing of HIV Reservoir With Immune Stimulation

3 augusti 2022 uppdaterad av: David Smith, University of California, San Diego

Perturbing the HIV Reservoir With Immune Stimulation

The purpose of this study is 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. 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

54

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • California
      • San Diego, California, Förenta staterna, 92103-8208
        • UCSD AntiViral Research Center (AVRC)

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 65 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria

  1. Documented HIV-1 infection more than 365 days ago (HIV antibody or viral load positive).
  2. Capable of signing written informed consent.
  3. Documented viral s suppression for at least 48 weeks (≤50 copies/mL)
  4. Men and women between 18 and 65 years of age.
  5. Read and comprehend English.
  6. Documented CD4 count at enrollment (>250 cells/µl)
  7. Reported CD4 nadir >100 cells/µl.
  8. Received seasonal flu vaccination at least 6 weeks prior to first trial injection (and not more recently)
  9. Received vaccination for pneumococcal disease at least 12 months prior to first trial injection (and not more recently)
  10. Started ART during chronic infection (> 6 months from estimated date of injection)

Exclusion Criteria

  1. Uncontrolled psychiatric condition.
  2. Under the influence of drug(s) or alcohol at time of screening.
  3. Any condition that, in the opinion of the investigator, would limit follow-up and adequate consent.
  4. History of allergic reactions to any of the proposed vaccines or egg allergy.
  5. History of Gullian Barre syndrome
  6. Receiving immunosuppressive medications.
  7. Pregnancy or lactation.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Grundläggande vetenskap
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Trippel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Övrig: 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).
Biologisk: Fluarix
Intramuscular injection with Fluarix® .
Biologisk: Pneumovax
Intramuscular injection with Pneumovax.
Övrig: Placebo
Intramuscular injection with sterile saline (placebo).
Övrig: 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).
Biologisk: Fluarix
Intramuscular injection with Fluarix® .
Biologisk: Pneumovax
Intramuscular injection with Pneumovax.
Övrig: Placebo
Intramuscular injection with sterile saline (placebo).
Övrig: 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).
Biologisk: Fluarix
Intramuscular injection with Fluarix® .
Biologisk: Pneumovax
Intramuscular injection with Pneumovax.
Övrig: Placebo
Intramuscular injection with sterile saline (placebo).
Övrig: 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®).
Biologisk: Fluarix
Intramuscular injection with Fluarix® .
Biologisk: Pneumovax
Intramuscular injection with Pneumovax.
Övrig: Placebo
Intramuscular injection with sterile saline (placebo).
Övrig: 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).
Biologisk: Fluarix
Intramuscular injection with Fluarix® .
Biologisk: Pneumovax
Intramuscular injection with Pneumovax.
Övrig: Placebo
Intramuscular injection with sterile saline (placebo).
Övrig: 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®).
Biologisk: Fluarix
Intramuscular injection with Fluarix® .
Biologisk: Pneumovax
Intramuscular injection with Pneumovax.
Övrig: Placebo
Intramuscular injection with sterile saline (placebo).

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change From Vaccination (Day 0) in Mean CD4+ T Cell-associated HIV RNA Transcription at Day 7
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University of California, San Diego

Samarbetspartners

National Institute of Allergy and Infectious Diseases (NIAID)

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 augusti 2016

Primärt slutförande (Faktisk)

1 april 2020

Avslutad studie (Faktisk)

1 januari 2022

Studieregistreringsdatum

Först inskickad

23 februari 2016

Först inskickad som uppfyllde QC-kriterierna

8 mars 2016

Första postat (Uppskatta)

14 mars 2016

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

24 augusti 2022

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

3 augusti 2022

Senast verifierad

1 augusti 2022

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 160089
  • 1R01AI118422-01A1 (U.S.S. NIH-anslag/kontrakt)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

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