Safety and Efficacy of Romidepsin and the Therapeutic Vaccine Vacc-4x for Reduction of the Latent HIV-1 Reservoir (REDUC)
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ClinicalTrials.gov Identifier: NCT02092116 |
Recruitment Status :
Completed
First Posted : March 19, 2014
Results First Posted : March 1, 2017
Last Update Posted : March 1, 2017
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Study Type | Interventional |
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Study Design | Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
HIV I Infection |
Interventions |
Drug: Romidepsin Biological: Vacc-4x Biological: rhuGM-CSF |
Enrollment | 26 |
Recruitment Details |
First subject screened 6 March 2014 and last subject last visit 25 June 2014 for Part A. First subject screened 19 May 2014 and last subject last visit 29 May 2015 for Part B. One clinical trial site at Aarhus University Hospital, Denmark |
Pre-assignment Details | 7 patients were screened and 6 patients were enrolled in Part A. 24 patients were screened and 20 patients were enrolled in Part B. |
Arm/Group Title | Part A | Part B |
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Pre-treatment phase of 2-4 weeks (Visit 1- Visit 2a) followed by viral reactivation phase of 3 weeks (Visit 2 to Visit 7) consisting of one cycle of romidepsin infusions at a dosing of 5 mg/m2 on days 0, 7, and 14. Post-activation phase of ~9 weeks (Visit 8 to Visit 11) to assess the effect of romidepsin on the size of latent HIV-1 reservoir. |
Pre-treatment phase of 2-4 weeks (Visit 1-Visit 2) followed by a therapeutic HIV-1 immunization phase of 12 weeks (Visit 2 to Visit 7) in which 1.2 mg Vacc-4x was administered together with 0.06 mg rhuGM-CSF at Visits 2, 3, 4, 5, 6 and 7 follow by a follow-up period of 2 weeks (Visit 8). A viral reactivation phase of 3 weeks (Visit 9-Visit 11) consisting of one cycle of 3 romidepsin infusions (5 mg/m2) followed by a post-treatment observation phase of ~9 weeks (Visit 12-Visit 13) to assess the effect of the investigational treatment on the size of the latent HIV-1 reservoir. A monitored antiretroviral pause of up to 16 weeks (Visit 14-Visit 33). |
Period Title: Overall Study | ||
Started | 6 | 20 |
Completed | 6 | 16 |
Not Completed | 0 | 4 |
Reason Not Completed | ||
Withdrawal by Subject | 0 | 3 |
Adverse Event | 0 | 1 |
Arm/Group Title | Part A | Part B | Total | |
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Pre-treatment phase of 2-4 weeks (Visit 1- Visit 2a) followed by viral reactivation phase of 3 weeks (Visit 2 to Visit 7) consisting of one cycle of romidepsin infusions at a dosing of 5 mg/m2 on days 0, 7, and 14. Post-activation phase of ~9 weeks (Visit 8 to Visit 11) to assess the effect of romidepsin on the size of latent HIV-1 reservoir. |
Pre-treatment phase of 2-4 weeks (Visit 1-Visit 2) followed by a therapeutic HIV-1 immunization phase of 12 weeks (Visit 2 to Visit 7) in which 1.2 mg Vacc-4x was administered together with 0.06 mg rhuGM-CSF at Visits 2, 3, 4, 5, 6 and 7 follow by a follow-up period of 2 weeks (Visit 8). A viral reactivation phase of 3 weeks (Visit 9-Visit 11) consisting of one cycle of 3 romidepsin infusions (5 mg/m2) followed by a post-treatment observation phase of ~9 weeks (Visit 12-Visit 13) to assess the effect of the investigational treatment on the size of the latent HIV-1 reservoir. A monitored antiretroviral pause of up to 16 weeks (Visit 14-Visit 33). |
Total of all reporting groups | |
Overall Number of Baseline Participants | 6 | 20 | 26 | |
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[Not Specified]
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Age, Customized
Measure Type: Number Unit of measure: Participants |
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>18 years | Number Analyzed | 6 participants | 20 participants | 26 participants |
6 | 20 | 26 | ||
Gender
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 6 participants | 20 participants | 26 participants | |
Female |
1 16.7%
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3 15.0%
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4 15.4%
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Male |
5 83.3%
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17 85.0%
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22 84.6%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 6 participants | 20 participants | 26 participants | |
American Indian or Alaska Native |
0 0.0%
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0 0.0%
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0 0.0%
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Asian |
0 0.0%
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1 5.0%
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1 3.8%
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Native Hawaiian or Other Pacific Islander |
0 0.0%
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0 0.0%
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0 0.0%
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Black or African American |
0 0.0%
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1 5.0%
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1 3.8%
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White |
6 100.0%
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17 85.0%
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23 88.5%
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More than one race |
0 0.0%
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0 0.0%
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0 0.0%
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Unknown or Not Reported |
0 0.0%
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1 5.0%
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1 3.8%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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Denmark | Number Analyzed | 6 participants | 20 participants | 26 participants |
6 | 20 | 26 | ||
Time since HIV diagnosis
Median (Full Range) Unit of measure: Years |
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Number Analyzed | 6 participants | 20 participants | 26 participants | |
13.3
(7.0 to 22.6)
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9.6
(2.6 to 28.7)
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9.85
(2.6 to 28.7)
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Time since HIV infection
[1] Median (Full Range) Unit of measure: Years |
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Number Analyzed | 4 participants | 19 participants | 23 participants | |
13.5
(10.7 to 23.1)
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10.2
(2.7 to 31.7)
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12.2
(2.7 to 31.7)
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[1]
Measure Analysis Population Description: Information was not available for 2 patients in Part A and for 1 patient in Part B.
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Time since ART initiation
Median (Full Range) Unit of measure: Years |
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Number Analyzed | 6 participants | 20 participants | 26 participants | |
10.05
(4.2 to 14.5)
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6.3
(2.4 to 18.1)
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6.9
(2.4 to 18.1)
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Latest pre-ART viral load
[1] Median (Full Range) Unit of measure: copies/mL |
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Number Analyzed | 6 participants | 18 participants | 24 participants | |
123300
(1977 to 2450000)
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67024
(3674 to 10000000)
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72597.5
(1977 to 10000000)
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[1]
Measure Analysis Population Description: Pre-ART viral load was not availabel for 2 patrients in Part B.
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Nadir CD4+ T-cell count
Median (Full Range) Unit of measure: 10^6 cells/L |
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Number Analyzed | 6 participants | 20 participants | 26 participants | |
246.5
(40 to 340)
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280
(60 to 710)
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267.5
(40 to 710)
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Mean CD4+ T-cell counts
Median (Full Range) Unit of measure: 10^6 cells/L |
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Number Analyzed | 6 participants | 20 participants | 26 participants | |
807.5
(570 to 1015)
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669.8
(465 to 1645)
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712.3
(465 to 1645)
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Name/Title: | Maja Sommerfelt |
Organization: | Bionor Pharma ASA |
Phone: | +4723010960 |
EMail: | ms@bionorpharma.com |
Responsible Party: | Bionor Immuno AS |
ClinicalTrials.gov Identifier: | NCT02092116 |
Other Study ID Numbers: |
BPC01-001 2013-004747-23 ( EudraCT Number ) |
First Submitted: | March 3, 2014 |
First Posted: | March 19, 2014 |
Results First Submitted: | November 8, 2016 |
Results First Posted: | March 1, 2017 |
Last Update Posted: | March 1, 2017 |