Perturbing of HIV Reservoir With Immune Stimulation
Condition: AIDS; HIV
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Fluarix; Pneumovax; Placebo
Intervention type(s): Biological; Biological; Other
Intervention description(s): Intramuscular injection with Fluarix® .; Intramuscular injection with Pneumovax.; Intramuscular injection with sterile saline (placebo).
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: HIV; AIDS; Immune Stimulation; HIV Reservoir