Trial Outcomes & Findings for Enhancement by Poly-ICLC During HIV-1 Infection (NCT NCT02071095)
NCT ID: NCT02071095
Last Updated: 2018-03-13
Results Overview
Safety measured by number of participants with adverse events.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
15 participants
Primary outcome timeframe
Up to 48 weeks
Results posted on
2018-03-13
Participant Flow
Participant milestones
| Measure |
Arm A: Poly-ICLC
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.
|
Arm B: Normal Saline
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 Study
STARTED
|
12
|
3
|
|
Overall Study
COMPLETED
|
12
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Enhancement by Poly-ICLC During HIV-1 Infection
Baseline characteristics by cohort
| Measure |
Arm A: Poly-ICLC
n=12 Participants
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.
|
Arm B: Normal Saline
n=3 Participants
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
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41.1 years
STANDARD_DEVIATION 9.32 • n=5 Participants
|
34.33 years
STANDARD_DEVIATION 4.03 • n=7 Participants
|
39.73 years
STANDARD_DEVIATION 8.61 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 48 weeksSafety measured by number of participants with adverse events.
Outcome measures
| Measure |
Arm A: Poly-ICLC
n=12 Participants
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.
|
Arm B: Normal Saline
n=3 Participants
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.
|
|---|---|---|
|
Number Participants With Adverse Events
|
11 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Day 2 and Day 4One of the biomarkers of cellular immune activation and exhaustion quantified by flow cytometry. Normal range is 7.8-500 pg/ml.
Outcome measures
| Measure |
Arm A: Poly-ICLC
n=12 Participants
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.
|
Arm B: Normal Saline
n=3 Participants
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.
|
|---|---|---|
|
Plasma Interferon-gamma-inducible Protein-10 (IP-10) Level
Day 2
|
381.43 pg/ml
Standard Deviation 187.67
|
100.65 pg/ml
Standard Deviation 13.5
|
|
Plasma Interferon-gamma-inducible Protein-10 (IP-10) Level
Day 4
|
450.51 pg/ml
Standard Deviation 144.9
|
139.39 pg/ml
Standard Deviation 42.74
|
SECONDARY outcome
Timeframe: Day 8the CD38-activation marker on CD8 T-cells (CD8/CD38).
Outcome measures
| Measure |
Arm A: Poly-ICLC
n=12 Participants
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.
|
Arm B: Normal Saline
n=3 Participants
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.
|
|---|---|---|
|
CD8 CD38 (Mean of Fluorescence)
|
8.69 mean fluorescent intensity (MFI)
Standard Deviation 6.77
|
2.35 mean fluorescent intensity (MFI)
Standard Deviation 2.27
|
SECONDARY outcome
Timeframe: at 48 weeksNatural killer cells or NK cells are part of the innate immune defense against infection and cancer.
Outcome measures
| Measure |
Arm A: Poly-ICLC
n=12 Participants
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.
|
Arm B: Normal Saline
n=3 Participants
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.
|
|---|---|---|
|
NK Cell Number
|
20.68 cells/µL
Standard Deviation 16.06
|
19.41 cells/µL
Standard Deviation 15.45
|
SECONDARY outcome
Timeframe: Baseline, Day 2, Day 4, Day 8, Day 28CD4+ 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.
Outcome measures
| Measure |
Arm A: Poly-ICLC
n=12 Participants
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.
|
Arm B: Normal Saline
n=3 Participants
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.
|
|---|---|---|
|
Percent Change in CD4+ Tcell-associated HIV-1 RNA as Compared to Baseline
Day 2
|
102.8 percent change
Standard Deviation 30.65
|
186.3 percent change
Standard Deviation 163.4
|
|
Percent Change in CD4+ Tcell-associated HIV-1 RNA as Compared to Baseline
Day 4
|
134.8 percent change
Standard Deviation 90.3
|
254.7 percent change
Standard Deviation 223.8
|
|
Percent Change in CD4+ Tcell-associated HIV-1 RNA as Compared to Baseline
Day 28
|
199.6 percent change
Standard Deviation 247.2
|
126.7 percent change
Standard Deviation 65.77
|
|
Percent Change in CD4+ Tcell-associated HIV-1 RNA as Compared to Baseline
Day 8
|
161.0 percent change
Standard Deviation 112.3
|
66.33 percent change
Standard Deviation 22.74
|
Adverse Events
Arm A: Poly-ICLC
Serious events: 11 serious events
Other events: 1 other events
Deaths: 0 deaths
Arm B: Normal Saline
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A: Poly-ICLC
n=12 participants at risk
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.
|
Arm B: Normal Saline
n=3 participants at risk
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.
|
|---|---|---|
|
General disorders
Chills
|
25.0%
3/12
|
0.00%
0/3
|
|
Surgical and medical procedures
erythema
|
41.7%
5/12
|
0.00%
0/3
|
|
Surgical and medical procedures
Pain
|
83.3%
10/12
|
0.00%
0/3
|
|
General disorders
Fatigue
|
58.3%
7/12
|
100.0%
3/3
|
|
General disorders
Fever
|
33.3%
4/12
|
0.00%
0/3
|
|
General disorders
Malaise
|
16.7%
2/12
|
33.3%
1/3
|
|
Nervous system disorders
Headache
|
8.3%
1/12
|
66.7%
2/3
|
|
Musculoskeletal and connective tissue disorders
Myalgias
|
16.7%
2/12
|
0.00%
0/3
|
Other adverse events
| Measure |
Arm A: Poly-ICLC
n=12 participants at risk
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.
|
Arm B: Normal Saline
n=3 participants at risk
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.
|
|---|---|---|
|
Blood and lymphatic system disorders
Low neutrophils count
|
8.3%
1/12
|
0.00%
0/3
|
Additional Information
Dr. Nina Bhardwaj
Icahn School of Medicine at Mount Sinai
Phone: 212-824-8427
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place