Trial Outcomes & Findings for HIV Reservoir Reduction With Interleukin-2 (NCT NCT03308786)
NCT ID: NCT03308786
Last Updated: 2022-09-28
Results Overview
Change in the number of infectious units per million resting CD4+ T cells (IUPM) from baseline to the end of study treatment, as measured by the Quantitative Viral Outgrowth Assay (QVOA).
TERMINATED
PHASE2
9 participants
15 months
2022-09-28
Participant Flow
Participant milestones
| Measure |
IL2 Treatment
Subcutaneous recombinant interleukin-2 (rIL2), 5 MIU twice daily for four consecutive days(cycle) every 8 weeks for 8 cycles, in addition to combination antiretroviral therapy.
Recombinant Interleukin-2: Subcutaneous recombinant interleukin-2 (rIL2), 5 MIU twice daily for four consecutive days(cycle) every 8 weeks for 8 cycles.
|
|---|---|
|
Overall Study
STARTED
|
9
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
| Measure |
IL2 Treatment
Subcutaneous recombinant interleukin-2 (rIL2), 5 MIU twice daily for four consecutive days(cycle) every 8 weeks for 8 cycles, in addition to combination antiretroviral therapy.
Recombinant Interleukin-2: Subcutaneous recombinant interleukin-2 (rIL2), 5 MIU twice daily for four consecutive days(cycle) every 8 weeks for 8 cycles.
|
|---|---|
|
Overall Study
study terminated after discussion with Safety Monitoring Committee
|
9
|
Baseline Characteristics
HIV Reservoir Reduction With Interleukin-2
Baseline characteristics by cohort
| Measure |
IL2 Treatment
n=9 Participants
Subcutaneous recombinant interleukin-2 (rIL2), 5 MIU twice daily for four consecutive days(cycle) every 8 weeks for 8 cycles, in addition to combination antiretroviral therapy.
Recombinant Interleukin-2: Subcutaneous recombinant interleukin-2 (rIL2), 5 MIU twice daily for four consecutive days(cycle) every 8 weeks for 8 cycles.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Age, Continuous
|
49 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=99 Participants
|
|
CD4+ T cell count ≥ 350 cells/mm^3
|
808 cells/mm^3
n=99 Participants
|
|
HIV-1 RNA < 50 copies/mL obtained within 60 days prior to study entry
|
9 Participants
n=99 Participants
|
|
on stable 3-antiretroviral medications with no changes for at least 4 weeks
|
9 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 15 monthsPopulation: No data was collected.
Change in the number of infectious units per million resting CD4+ T cells (IUPM) from baseline to the end of study treatment, as measured by the Quantitative Viral Outgrowth Assay (QVOA).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 15 monthsPopulation: No data was collected.
Correlation coefficient between measures of the latent HIV reservoir by QVOA and measures of the latent HIV reservoir by the intact proviral DNA assay.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 15 monthsPopulation: No data was collected.
Correlation coefficient between measures of the latent HIV reservoir by QVOA and measures of the latent HIV reservoir by the Tat-rev inducible limiting dilution assay (TILDA).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 15 monthsPopulation: No data was collected.
Correlation coefficient between measures of the latent HIV reservoir by QVOA and measures of the latent HIV reservoir by the Envelope Detection by Induced Transcription-based Sequencing (EDITS).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 15 monthsPopulation: No data was collected.
Number of inducible cell-associated HIV mRNA copies per million CD4+ T cells at the beginning and end of rIL2 cycles 1, 4, and 8.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline, day 7Plasma HIV RNA copies/mL by PCR at the beginning and end of rIL2 cycle 1.
Outcome measures
| Measure |
IL2 Treatment
n=9 Participants
Subcutaneous recombinant interleukin-2 (rIL2), 5 MIU twice daily for four consecutive days(cycle) every 8 weeks for 8 cycles, in addition to combination antiretroviral therapy.
Recombinant Interleukin-2: Subcutaneous recombinant interleukin-2 (rIL2), 5 MIU twice daily for four consecutive days(cycle) every 8 weeks for 8 cycles
|
|---|---|
|
Plasma HIV RNA During rIL2 Exposure
baseline
|
10 RNA copies/mL
Standard Deviation 0
|
|
Plasma HIV RNA During rIL2 Exposure
day 7
|
298 RNA copies/mL
Standard Deviation 522
|
SECONDARY outcome
Timeframe: baseline, day 7Change in the percent of NK cells expressing CD16+CD56+ by flow cytometry from baseline to the end of study treatment.
Outcome measures
| Measure |
IL2 Treatment
n=9 Participants
Subcutaneous recombinant interleukin-2 (rIL2), 5 MIU twice daily for four consecutive days(cycle) every 8 weeks for 8 cycles, in addition to combination antiretroviral therapy.
Recombinant Interleukin-2: Subcutaneous recombinant interleukin-2 (rIL2), 5 MIU twice daily for four consecutive days(cycle) every 8 weeks for 8 cycles
|
|---|---|
|
Natural Killer (NK) Cell Phenotype During rIL2 Exposure
baseline
|
28.8 percentage of cells
Interval 19.8 to 37.5
|
|
Natural Killer (NK) Cell Phenotype During rIL2 Exposure
day 7
|
35.8 percentage of cells
Interval 30.9 to 39.2
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SECONDARY outcome
Timeframe: baseline, day 7Change in the percent of NK cells expressing CD56+CD16- by flow cytometry from baseline to the end of study treatment.
Outcome measures
| Measure |
IL2 Treatment
n=9 Participants
Subcutaneous recombinant interleukin-2 (rIL2), 5 MIU twice daily for four consecutive days(cycle) every 8 weeks for 8 cycles, in addition to combination antiretroviral therapy.
Recombinant Interleukin-2: Subcutaneous recombinant interleukin-2 (rIL2), 5 MIU twice daily for four consecutive days(cycle) every 8 weeks for 8 cycles
|
|---|---|
|
Natural Killer (NK) Cell Phenotype During rIL2 Exposure
baseline
|
4.5 percentage of cells
Interval 3.1 to 5.2
|
|
Natural Killer (NK) Cell Phenotype During rIL2 Exposure
day 7
|
12.7 percentage of cells
Interval 8.3 to 17.1
|
Adverse Events
IL2 Treatment
Serious adverse events
| Measure |
IL2 Treatment
n=9 participants at risk
Subcutaneous recombinant interleukin-2 (rIL2), 5 MIU twice daily for four consecutive days(cycle) every 8 weeks for 8 cycles, in addition to combination antiretroviral therapy.
Recombinant Interleukin-2: Subcutaneous recombinant interleukin-2 (rIL2), 5 MIU twice daily for four consecutive days(cycle) every 8 weeks for 8 cycles
|
|---|---|
|
Vascular disorders
suspected capillary leak syndrome
|
11.1%
1/9 • Number of events 1 • Adverse event data were collected until the study was terminated. This period was the time between enrollment into the study and study termination. The duration ranged from 8.3 months to 14.6 months,.
Total number of participants at risk for All-Cause Mortality is 9. All-Cause mortality was zero.
|
Other adverse events
| Measure |
IL2 Treatment
n=9 participants at risk
Subcutaneous recombinant interleukin-2 (rIL2), 5 MIU twice daily for four consecutive days(cycle) every 8 weeks for 8 cycles, in addition to combination antiretroviral therapy.
Recombinant Interleukin-2: Subcutaneous recombinant interleukin-2 (rIL2), 5 MIU twice daily for four consecutive days(cycle) every 8 weeks for 8 cycles
|
|---|---|
|
Endocrine disorders
biochemical hypothyroidism
|
22.2%
2/9 • Number of events 2 • Adverse event data were collected until the study was terminated. This period was the time between enrollment into the study and study termination. The duration ranged from 8.3 months to 14.6 months,.
Total number of participants at risk for All-Cause Mortality is 9. All-Cause mortality was zero.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place