Perturbing of HIV Reservoir With Immune Stimulation

HIV Clinical Trial

Official title:

Perturbing the HIV Reservoir With Immune Stimulation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02707692
• Other study ID #: 160089
• Secondary ID: 1R01AI118422-01A
• Status: Completed
• Phase: N/A
• Start date: August 2016
• Est. completion date: January 2022

Study information

• Verified date: August 2022
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: January 2022
• Est. primary completion date: April 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• AIDS
• HIV

Intervention

Biological:
• Fluarix
Intramuscular injection with Fluarix® .
• Pneumovax
Intramuscular injection with Pneumovax.

Other:
• Placebo
Intramuscular injection with sterile saline (placebo).

Locations

Country	Name	City	State
United States	UCSD Antiviral Research Center (AVRC)	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Diego	National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Vaccination (Day 0) in Mean CD4+ T Cell-associated HIV RNA Transcription at 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