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Enhancement by Poly-ICLC During HIV-1 Infection (Poly-ICLC)

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ClinicalTrials.gov Identifier: NCT02071095
Recruitment Status : Completed
First Posted : February 25, 2014
Results First Posted : March 13, 2018
Last Update Posted : March 13, 2018
Sponsor:
Collaborators:
The Campbell Foundation
Oncovir, Inc.
National Institutes of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Nina Bhardwaj, Icahn School of Medicine at Mount Sinai

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition HIV-1 Infected Adults With Chronic HIV-1 Infection
Interventions Drug: Arm A: Poly-ICLC
Drug: Arm B: Normal Saline
Enrollment 15

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm A: Poly-ICLC Arm B: Normal Saline
Hide Arm/Group Description Poly-ICLC: Poly-ICLC (Hiltonol®, Oncovir) Administration - On days 1 and 2, patients randomized to this arm will be injected subcutaneously in the arm with 1.4 mg of Poly-ICLC (Hiltonol®, Oncovir). Each subject will receive a total of 2 SC doses of Poly-ICLC. The volume of each injection is 0.7ml. Normal Saline: Normal Saline - On days 1 and 2, patients randomized to this arm will be injected subcutaneously in the arm with normal saline obtained from the Rockefeller University Pharmacy. Each subject will receive a total of 2 SC doses of normal saline. The volume of each injection is 0.7ml.
Period Title: Overall Study
Started 12 3
Completed 12 3
Not Completed 0 0
Arm/Group Title Arm A: Poly-ICLC Arm B: Normal Saline Total
Hide Arm/Group Description Poly-ICLC: Poly-ICLC (Hiltonol®, Oncovir) Administration - On days 1 and 2, patients randomized to this arm will be injected subcutaneously in the arm with 1.4 mg of Poly-ICLC (Hiltonol®, Oncovir). Each subject will receive a total of 2 SC doses of Poly-ICLC. The volume of each injection is 0.7ml. Normal Saline: Normal Saline - On days 1 and 2, patients randomized to this arm will be injected subcutaneously in the arm with normal saline obtained from the Rockefeller University Pharmacy. Each subject will receive a total of 2 SC doses of normal saline. The volume of each injection is 0.7ml. Total of all reporting groups
Overall Number of Baseline Participants 12 3 15
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants 3 participants 15 participants
41.1  (9.32) 34.33  (4.03) 39.73  (8.61)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 3 participants 15 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
12
 100.0%
3
 100.0%
15
 100.0%
1.Primary Outcome
Title Number Participants With Adverse Events
Hide Description Safety measured by number of participants with adverse events.
Time Frame Up to 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm A: Poly-ICLC Arm B: Normal Saline
Hide Arm/Group Description:
Poly-ICLC: Poly-ICLC (Hiltonol®, Oncovir) Administration - On days 1 and 2, patients randomized to this arm will be injected subcutaneously in the arm with 1.4 mg of Poly-ICLC (Hiltonol®, Oncovir). Each subject will receive a total of 2 SC doses of Poly-ICLC. The volume of each injection is 0.7ml.
Normal Saline: Normal Saline - On days 1 and 2, patients randomized to this arm will be injected subcutaneously in the arm with normal saline obtained from the Rockefeller University Pharmacy. Each subject will receive a total of 2 SC doses of normal saline. The volume of each injection is 0.7ml.
Overall Number of Participants Analyzed 12 3
Measure Type: Count of Participants
Unit of Measure: Participants
11
  91.7%
3
 100.0%
2.Secondary Outcome
Title Plasma Interferon-gamma-inducible Protein-10 (IP-10) Level
Hide Description One of the biomarkers of cellular immune activation and exhaustion quantified by flow cytometry. Normal range is 7.8–500 pg/ml.
Time Frame Day 2 and Day 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm A: Poly-ICLC Arm B: Normal Saline
Hide Arm/Group Description:
Poly-ICLC: Poly-ICLC (Hiltonol®, Oncovir) Administration - On days 1 and 2, patients randomized to this arm will be injected subcutaneously in the arm with 1.4 mg of Poly-ICLC (Hiltonol®, Oncovir). Each subject will receive a total of 2 SC doses of Poly-ICLC. The volume of each injection is 0.7ml.
Normal Saline: Normal Saline - On days 1 and 2, patients randomized to this arm will be injected subcutaneously in the arm with normal saline obtained from the Rockefeller University Pharmacy. Each subject will receive a total of 2 SC doses of normal saline. The volume of each injection is 0.7ml.
Overall Number of Participants Analyzed 12 3
Mean (Standard Deviation)
Unit of Measure: pg/ml
Day 2 381.43  (187.67) 100.65  (13.5)
Day 4 450.51  (144.9) 139.39  (42.74)
3.Secondary Outcome
Title CD8 CD38 (Mean of Fluorescence)
Hide Description the CD38-activation marker on CD8 T-cells (CD8/CD38).
Time Frame Day 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm A: Poly-ICLC Arm B: Normal Saline
Hide Arm/Group Description:
Poly-ICLC: Poly-ICLC (Hiltonol®, Oncovir) Administration - On days 1 and 2, patients randomized to this arm will be injected subcutaneously in the arm with 1.4 mg of Poly-ICLC (Hiltonol®, Oncovir). Each subject will receive a total of 2 SC doses of Poly-ICLC. The volume of each injection is 0.7ml.
Normal Saline: Normal Saline - On days 1 and 2, patients randomized to this arm will be injected subcutaneously in the arm with normal saline obtained from the Rockefeller University Pharmacy. Each subject will receive a total of 2 SC doses of normal saline. The volume of each injection is 0.7ml.
Overall Number of Participants Analyzed 12 3
Mean (Standard Deviation)
Unit of Measure: mean fluorescent intensity (MFI)
8.69  (6.77) 2.35  (2.27)
4.Secondary Outcome
Title NK Cell Number
Hide Description Natural killer cells or NK cells are part of the innate immune defense against infection and cancer.
Time Frame at 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm A: Poly-ICLC Arm B: Normal Saline
Hide Arm/Group Description:
Poly-ICLC: Poly-ICLC (Hiltonol®, Oncovir) Administration - On days 1 and 2, patients randomized to this arm will be injected subcutaneously in the arm with 1.4 mg of Poly-ICLC (Hiltonol®, Oncovir). Each subject will receive a total of 2 SC doses of Poly-ICLC. The volume of each injection is 0.7ml.
Normal Saline: Normal Saline - On days 1 and 2, patients randomized to this arm will be injected subcutaneously in the arm with normal saline obtained from the Rockefeller University Pharmacy. Each subject will receive a total of 2 SC doses of normal saline. The volume of each injection is 0.7ml.
Overall Number of Participants Analyzed 12 3
Mean (Standard Deviation)
Unit of Measure: cells/µL
20.68  (16.06) 19.41  (15.45)
5.Secondary Outcome
Title Percent Change in CD4+ Tcell-associated HIV-1 RNA as Compared to Baseline
Hide Description CD4+ Tcell-associated HIV-1 RNA to determine whether Poly-ICLC disrupts viral latency in HIV-1-infected individuals on anti-retroviral therapy.Viral transcription assessed by monitoring cell associated HIV-1 RNA. Percent change compared to baseline.
Time Frame Baseline, Day 2, Day 4, Day 8, Day 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm A: Poly-ICLC Arm B: Normal Saline
Hide Arm/Group Description:
Poly-ICLC: Poly-ICLC (Hiltonol®, Oncovir) Administration - On days 1 and 2, patients randomized to this arm will be injected subcutaneously in the arm with 1.4 mg of Poly-ICLC (Hiltonol®, Oncovir). Each subject will receive a total of 2 SC doses of Poly-ICLC. The volume of each injection is 0.7ml.
Normal Saline: Normal Saline - On days 1 and 2, patients randomized to this arm will be injected subcutaneously in the arm with normal saline obtained from the Rockefeller University Pharmacy. Each subject will receive a total of 2 SC doses of normal saline. The volume of each injection is 0.7ml.
Overall Number of Participants Analyzed 12 3
Mean (Standard Deviation)
Unit of Measure: percent change
Day 2 102.8  (30.65) 186.3  (163.4)
Day 4 134.8  (90.3) 254.7  (223.8)
Day 8 161.0  (112.3) 66.33  (22.74)
Day 28 199.6  (247.2) 126.7  (65.77)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm A: Poly-ICLC Arm B: Normal Saline
Hide Arm/Group Description Poly-ICLC: Poly-ICLC (Hiltonol®, Oncovir) Administration - On days 1 and 2, patients randomized to this arm will be injected subcutaneously in the arm with 1.4 mg of Poly-ICLC (Hiltonol®, Oncovir). Each subject will receive a total of 2 SC doses of Poly-ICLC. The volume of each injection is 0.7ml. Normal Saline: Normal Saline - On days 1 and 2, patients randomized to this arm will be injected subcutaneously in the arm with normal saline obtained from the Rockefeller University Pharmacy. Each subject will receive a total of 2 SC doses of normal saline. The volume of each injection is 0.7ml.
All-Cause Mortality
Arm A: Poly-ICLC Arm B: Normal Saline
Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/3 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Arm A: Poly-ICLC Arm B: Normal Saline
Affected / at Risk (%) Affected / at Risk (%)
Total   11/12 (91.67%)   3/3 (100.00%) 
General disorders     
Chills  3/12 (25.00%)  0/3 (0.00%) 
Fatigue  7/12 (58.33%)  3/3 (100.00%) 
Fever  4/12 (33.33%)  0/3 (0.00%) 
Malaise  2/12 (16.67%)  1/3 (33.33%) 
Musculoskeletal and connective tissue disorders     
Myalgias  2/12 (16.67%)  0/3 (0.00%) 
Nervous system disorders     
Headache  1/12 (8.33%)  2/3 (66.67%) 
Surgical and medical procedures     
erythema [1]  5/12 (41.67%)  0/3 (0.00%) 
Pain [1]  10/12 (83.33%)  0/3 (0.00%) 
[1]
Injection site reaction
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm A: Poly-ICLC Arm B: Normal Saline
Affected / at Risk (%) Affected / at Risk (%)
Total   1/12 (8.33%)   0/3 (0.00%) 
Blood and lymphatic system disorders     
Low neutrophils count  1/12 (8.33%)  0/3 (0.00%) 
Small sample size, gender homogeneity, and exclusion of older individuals (>55 years) and common comorbidities such as cardiovascular disease and diabetes limit the generalizability of the safety findings in the HIV-infected population as a whole.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Nina Bhardwaj
Organization: Icahn School of Medicine at Mount Sinai
Phone: 212-824-8427
Publications:
Elliot, J., et al. The Safety and Effect of Multiple Doses of Vorinostat on HIV Transcription in HIV+ Patients Receiving cART. in Conference on Retroviruses and Opportunistic Infections (CROI) (2013).
Winckelmann, A., et al. Toll-like Receptor 9 Agonist Treatment Decreases the Proviral Reservoir in Peripheral Blood and Could Impact HIV-specific Immunity in Patients on cART. Conference on Retroviruses and Opportunistic Infections (CROI) (2013).
Checkley Luttge, M., et al. Natural Killer Cells Can Target and Eliminate Latently HIV-1-Infected Primary T cells following Proviral Reactivation. Conference on Retroviruses and Opportunistic Infections (CROI) (2013).
Poly-ICLC Investigational Brochure (Hiltonol®, Oncovir).
Responsible Party: Nina Bhardwaj, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT02071095     History of Changes
Other Study ID Numbers: GCO 13-0482
Campbell Foundation ( Other Grant/Funding Number: Campbell Foundation )
1R21AI110736-01 ( U.S. NIH Grant/Contract )
First Submitted: February 21, 2014
First Posted: February 25, 2014
Results First Submitted: December 21, 2017
Results First Posted: March 13, 2018
Last Update Posted: March 13, 2018