Perturbing of HIV Reservoir With Immune Stimulation
Perturbing the HIV Reservoir With Immune Stimulation
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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California
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San Diego, California, Verenigde Staten, 92103-8208
- UCSD AntiViral Research Center (AVRC)
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Fundamentele wetenschap
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verdrievoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Ander: 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).
|
|
Ander: 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).
|
|
Ander: 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).
|
|
Ander: 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).
|
|
Ander: 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).
|
|
Ander: 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).
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change From Vaccination (Day 0) in Mean CD4+ T Cell-associated HIV RNA Transcription at Day 7
Tijdsspanne: Day 0 and Day 7
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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.
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Day 0 and Day 7
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Medewerkers en onderzoekers
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
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Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 160089
- 1R01AI118422-01A1 (Subsidie/contract van de Amerikaanse NIH)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
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