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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
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
Bionor Immuno AS

Study Type: Interventional
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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations

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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
7 patients were screened and 6 patients were enrolled in Part A. 24 patients were screened and 20 patients were enrolled in Part B.

Reporting Groups
  Description
Part A

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.

Part B

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).


Participant Flow:   Overall Study
    Part A   Part B
STARTED   6   20 
COMPLETED   6   16 
NOT COMPLETED   0   4 
Withdrawal by Subject                0                3 
Adverse Event                0                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Part A

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.

Part B

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 Total of all reporting groups

Baseline Measures
   Part A   Part B   Total 
Overall Participants Analyzed 
[Units: Participants]
 6   20   26 
Age, Customized 
[Units: Participants]
     
>18 years       
Participants Analyzed   6   20   26 
>18 years   6   20   26 
Gender 
[Units: Participants]
Count of Participants
     
Participants Analyzed   6   20   26 
Female      1  16.7%      3  15.0%      4  15.4% 
Male      5  83.3%      17  85.0%      22  84.6% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Participants Analyzed   6   20   26 
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      1   5.0%      1   3.8% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      0   0.0%      1   5.0%      1   3.8% 
White      6 100.0%      17  85.0%      23  88.5% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      1   5.0%      1   3.8% 
Region of Enrollment 
[Units: Participants]
     
Denmark       
Participants Analyzed   6   20   26 
Denmark   6   20   26 
Time since HIV diagnosis 
[Units: Years]
Median (Full Range)
     
Participants Analyzed   6   20   26 
   13.3 
 (7.0 to 22.6) 
 9.6 
 (2.6 to 28.7) 
 9.85 
 (2.6 to 28.7) 
Time since HIV infection [1] 
[Units: Years]
Median (Full Range)
     
Participants Analyzed   4   19   23 
   13.5 
 (10.7 to 23.1) 
 10.2 
 (2.7 to 31.7) 
 12.2 
 (2.7 to 31.7) 
[1] Information was not available for 2 patients in Part A and for 1 patient in Part B.
Time since ART initiation 
[Units: Years]
Median (Full Range)
     
Participants Analyzed   6   20   26 
   10.05 
 (4.2 to 14.5) 
 6.3 
 (2.4 to 18.1) 
 6.9 
 (2.4 to 18.1) 
Latest pre-ART viral load [1] 
[Units: copies/mL]
Median (Full Range)
     
Participants Analyzed   6   18   24 
   123300 
 (1977 to 2450000) 
 67024 
 (3674 to 10000000) 
 72597.5 
 (1977 to 10000000) 
[1] Pre-ART viral load was not availabel for 2 patrients in Part B.
Nadir CD4+ T-cell count 
[Units: 10^6 cells/L]
Median (Full Range)
     
Participants Analyzed   6   20   26 
   246.5 
 (40 to 340) 
 280 
 (60 to 710) 
 267.5 
 (40 to 710) 
Mean CD4+ T-cell counts 
[Units: 10^6 cells/L]
Median (Full Range)
     
Participants Analyzed   6   20   26 
   807.5 
 (570 to 1015) 
 669.8 
 (465 to 1645) 
 712.3 
 (465 to 1645) 


  Outcome Measures

1.  Primary:   Part A: Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)   [ Time Frame: 3 weeks ]

2.  Primary:   Part B: Changes From Baseline in HIV-1 Reservoir (Total HIV-1DNA; Integrated HIV-1 DNA in Unfractionated CD4+ T Cells and Replication Competent Provirus.   [ Time Frame: Day 161/175 ]

3.  Secondary:   Part A: Changes From Baseline in HIV-1 Reservoir (Total HIV-1DNA; Integrated HIV-1 DNA in Unfractionated CD4+ T Cells and Replication Competent Provirus. Estimates of Change From Baseline of the Size of the Latent HIV-1 Reservoir in CD4+ Cells.   [ Time Frame: Day 56/84 ]

4.  Secondary:   Part B: Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)   [ Time Frame: 287 days ]

5.  Secondary:   Part B: Level of HIV-1 Transcription.   [ Time Frame: Day 105, 112 and 119 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Maja Sommerfelt
Organization: Bionor Pharma ASA
phone: +4723010960
e-mail: ms@bionorpharma.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Bionor Immuno AS
ClinicalTrials.gov Identifier: NCT02092116     History of Changes
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