NCT02707692

Perturbing of HIV Reservoir With Immune Stimulation

Perturbing the HIV Reservoir With Immune Stimulation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: University of California, San Diego · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• AIDS
• HIV

Interventions

Type	Name	Description
BIOLOGICAL	Fluarix	Intramuscular injection with Fluarix® .
BIOLOGICAL	Pneumovax	Intramuscular injection with Pneumovax.
OTHER	Placebo	Intramuscular injection with sterile saline (placebo).

Timeline

• Start date: 2016-08-01
• Primary completion: 2020-04-01
• Completion: 2022-01-01
• First posted: 2016-03-14
• Last updated: 2022-08-24
• Results posted: 2022-08-24

Locations

1 site across 1 country: United States