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
Enrollment	26

Participant Flow

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
Arm/Group Description	Pre-treatment phase of 2-4 weeks (V...	Pre-treatment phase of 2-4 weeks (V...
Arm/Group Description	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

Baseline Characteristics

Arm/Group Title		Part A	Part B	Total
Arm/Group Description		Pre-treatment phase of 2-4 weeks (V...	Pre-treatment phase of 2-4 weeks (V...	Total of all reporting groups
Arm/Group Description		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
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Customized Measure Type: Number Unit of measure: Participants
>18 years	Number Analyzed	6 participants	20 participants	26 participants
>18 years		6	20	26
Gender Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	6 participants	20 participants	26 participants
	Female	1 16.7%	3 15.0%	4 15.4%
	Male	5 83.3%	17 85.0%	22 84.6%
Race (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	6 participants	20 participants	26 participants
	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 Measure Type: Number Unit of measure: Participants
Denmark	Number Analyzed	6 participants	20 participants	26 participants
Denmark		6	20	26
Time since HIV diagnosis Median (Full Range) Unit of measure: Years
	Number Analyzed	6 participants	20 participants	26 participants
		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] Median (Full Range) Unit of measure: Years
	Number Analyzed	4 participants	19 participants	23 participants
		13.5 (10.7 to 23.1)	10.2 (2.7 to 31.7)	12.2 (2.7 to 31.7)
		[1] Measure Analysis Population Description: Information was not available for 2 patients in Part A and for 1 patient in Part B.
Time since ART initiation Median (Full Range) Unit of measure: Years
	Number Analyzed	6 participants	20 participants	26 participants
		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] Median (Full Range) Unit of measure: copies/mL
	Number Analyzed	6 participants	18 participants	24 participants
		123300 (1977 to 2450000)	67024 (3674 to 10000000)	72597.5 (1977 to 10000000)
		[1] Measure Analysis Population Description: Pre-ART viral load was not availabel for 2 patrients in Part B.
Nadir CD4+ T-cell count Median (Full Range) Unit of measure: 10^6 cells/L
	Number Analyzed	6 participants	20 participants	26 participants
		246.5 (40 to 340)	280 (60 to 710)	267.5 (40 to 710)
Mean CD4+ T-cell counts Median (Full Range) Unit of measure: 10^6 cells/L
	Number Analyzed	6 participants	20 participants	26 participants
		807.5 (570 to 1015)	669.8 (465 to 1645)	712.3 (465 to 1645)

Outcome Measures

1.Primary Outcome


Title	Part A: Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)
Description	Safety and tolerability evaluation as measured by adverse events (AE) ...
Description	Safety and tolerability evaluation as measured by adverse events (AE) and serious adverse events (SAE).
Time Frame	3 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Part A
Arm/Group Description:	Pre-treatment phase of 2-4 weeks (V...
Arm/Group Description:	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.
Overall Number of Participants Analyzed	6
Measure Type: Number Unit of Measure: participants
Treatment emergent adverse events	6
Adverse reactions, grade 1	6
Adverse reactions, grade 2	1
Related to Romidepsin	6
Not related	3

2.Primary Outcome


Title	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.
Description	Total HIV-1 DNA and inte...
Description	Total HIV-1 DNA and integrated HIV-1 DNA were analysed by MMRM analysis (copies/10^6 CD4+ T cells). To estimate the frequency of infectious units per 10^6 resting memory CD4+ T cells a quantitative viral outgrowth assay (qVOA) was used. Blood samples were obtained at Day 0, Day 105 and Day 161.
Time Frame	Day 161/175

Outcome Measure Data

Analysis Population Description

4 patients were excluded; 3 discontinued and 1 sample was not eligible for analysis.

Sensitivity of the qVOA was low; 2/3 of all measurements were under the limit of detection. 6 subjects had quantifiable viral outgrowth on baseline, 8 had viral outgrowth after immunization (Day 105) and 6 had viral outgrowth after romidepsin (Day 161).


Arm/Group Title		Part B
Arm/Group Description:		Pre-treatment phase of 2-4 weeks (V...
Arm/Group Description:		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).
Overall Number of Participants Analyzed		16
Mean (95% Confidence Interval) Unit of Measure: Estimated % change from baseline
Total HIV-1 DNA, day 161	Number Analyzed	16 participants
Total HIV-1 DNA, day 161		-39.71 (-58.94 to -11.47)
Integrated HIV-1 DNA, day 175	Number Analyzed	16 participants
Integrated HIV-1 DNA, day 175		-19.21 (-38.61 to 6.31)
Replication competent provirus, day 161	Number Analyzed	6 participants
Replication competent provirus, day 161		-38 (-67 to -8)

3.Secondary Outcome


Title	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.
Description	Total HIV-1 DNA and inte...
Description	Total HIV-1 DNA and integrated HIV-1 DNA were analysed by MMRM analysis (copies/10^6 CD4+ T cells). To estimate the frequency of infectious units per 10^6 resting memory CD4+ T cells a quantitative viral outgrowth assay (qVOA) was used. Total HIV-1 DNA was measured at Day 84
Time Frame	Day 56/84

Outcome Measure Data

Analysis Population Description

1 patient did not have a quantifiable load of total HIV-1 DNA at Day 84 and 2 patients diod not have a quantifiable load of replication competent provirus at day 56.


Arm/Group Title		Part A
Arm/Group Description:		Pre-treatment phase of 2-4 weeks (V...
Arm/Group Description:		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.
Overall Number of Participants Analyzed		6
Mean (Standard Deviation) Unit of Measure: copies/10^6 CD4+ T cells
Total HIV-1 DNA, Basline	Number Analyzed	6 participants
Total HIV-1 DNA, Basline		791.7 (790.6)
Total HIV-1 DNA, Day 84	Number Analyzed	5 participants
Total HIV-1 DNA, Day 84		718.8 (530.2)
Integrated HIV-1 DNA, Baseline	Number Analyzed	6 participants
Integrated HIV-1 DNA, Baseline		2825.6 (1145.6)
Integrated HIV-1 DNA, Day 84	Number Analyzed	6 participants
Integrated HIV-1 DNA, Day 84		4846.9 (3698.4)
Replication competent provirus, Baseline	Number Analyzed	4 participants
Replication competent provirus, Baseline		0.39 (0.26)
Replication competent provirus, Day 56	Number Analyzed	4 participants
Replication competent provirus, Day 56		0.43 (0.31)

4.Secondary Outcome


Title	Part B: Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)
Description	Safety and tolerability evaluation of romidepsin and Vacc-4x in combin...
Description	Safety and tolerability evaluation of romidepsin and Vacc-4x in combination with GM-CSF as measured by adverse events (AE) and serious adverse events (SAE).
Time Frame	287 days

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Part B
Arm/Group Description:	Pre-treatment phase of 2-4 weeks (V...
Arm/Group Description:	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).
Overall Number of Participants Analyzed	20
Measure Type: Number Unit of Measure: participants
Non-treatment emergent adverse events	1
Treatment emergent adverse events	20
Serious adverse event	1
Adverse reaction, grade 1	20
Adverse reaction, grade 2	5
Adverse reaction, grade 3	1
Related to Vacc-4x and GM-CSF	19
Related to Romidepsin	17
Not related	16

5.Secondary Outcome


Title	Part B: Level of HIV-1 Transcription.
Description	At day 105, 112 and 119 patients receive romidepsin and 4 hours after ...
Description	At day 105, 112 and 119 patients receive romidepsin and 4 hours after each administration HIV transcription is measured as unspliced HIV-1 RNA.
Time Frame	Day 105, 112 and 119

Outcome Measure Data

Analysis Population Description

All available samples were included in this analysis; 3 withdrew consent and 2 (3 for day 119) did not have analyzable samples.


Arm/Group Title		Part B
Arm/Group Description:		Pre-treatment phase of 2-4 weeks (V...
Arm/Group Description:		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).
Overall Number of Participants Analyzed		15
Mean (Standard Deviation) Unit of Measure: copies/10^6 CD4+ T cells
Day 105, before romidepsin	Number Analyzed	15 participants
Day 105, before romidepsin		6.95 (5.29)
Day 105, 4 hours post romidepsin	Number Analyzed	15 participants
Day 105, 4 hours post romidepsin		12.77 (11.19)
Day 112, 4 hours post romidepsin	Number Analyzed	15 participants
Day 112, 4 hours post romidepsin		22.98 (16.58)
Day 119, 4 hours post romidepsin	Number Analyzed	14 participants
Day 119, 4 hours post romidepsin		25.91 (21.78)

Adverse Events

Time Frame	Adverse events were collected from first treatment (Day 0) to the last visit (day 11 for Part A and day 287 for part B). Any signs or symptoms occurring between Screening/Visit 1 and Visit 2 (day 0)was recorded as Medical History.
Adverse Event Reporting Description	[Not Specified]

Arm/Group Title	Part A		Part B
Arm/Group Description	Pre-treatment phase of 2-4 weeks (V...		Pre-treatment phase of 2-4 weeks (V...
Arm/Group Description	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 romidepsin infusion (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).
All-Cause Mortality
	Part A		Part B
	Affected / at Risk (%)		Affected / at Risk (%)
Total	--/--		--/--
Serious Adverse Events Serious Adverse Events
	Part A		Part B
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/6 (0.00%)		1/20 (5.00%)
Psychiatric disorders
Alcohol withdrawal syndrome ^† 1 [1]	0/6 (0.00%)	0	1/20 (5.00%)	3
† Indicates events were collected by systematic assessment 1 Term from vocabulary, MedDRA (17.0) [1] One subject (01-225) presented three SAEs; all three were described as “alcohol withdrawal syndrome” and assessed as not related to Vacc-4x and GM-CSF and romidepsin
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Part A		Part B
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/6 (100.00%)		20/20 (100.00%)
Blood and lymphatic system disorders
Lymphadenitis ^† 1	0/6 (0.00%)	0	1/20 (5.00%)	1
Cardiac disorders
Palpitations ^† 1	1/6 (16.67%)	2	0/20 (0.00%)	0
Ear and labyrinth disorders
Tinnitus ^† 1	0/6 (0.00%)	0	1/20 (5.00%)	1
Gastrointestinal disorders
Nausea ^† 1	4/6 (66.67%)	11	15/20 (75.00%)	26
Abdominal Pain upper ^† 1	1/6 (16.67%)	1	1/20 (5.00%)	1
Constipation ^† 1	1/6 (16.67%)	1	4/20 (20.00%)	4
Diarrhoea ^† 1	1/6 (16.67%)	1	1/20 (5.00%)	2
Gastrointestinal pain ^† 1	1/6 (16.67%)	1	0/20 (0.00%)	0
Gastrooesophageal reflux disease ^† 1	1/6 (16.67%)	1	1/20 (5.00%)	1
Vomitting ^† 1	0/6 (0.00%)	0	2/20 (10.00%)	3
General disorders
Gastrointestinal sounds abnormal ^† 1	3/6 (50.00%)	4	1/20 (5.00%)	1
Fatigue ^† 1	3/6 (50.00%)	5	15/20 (75.00%)	28
Asthenia ^† 1	1/6 (16.67%)	1	0/20 (0.00%)	0
Chills ^† 1	1/6 (16.67%)	1	0/20 (0.00%)	0
Influenza like illness ^† 1	1/6 (16.67%)	1	4/20 (20.00%)	4
Malaise ^† 1	1/6 (16.67%)	1	1/20 (5.00%)	1
Pyrexia ^† 1	1/6 (16.67%)	1	3/20 (15.00%)	3
Injection site Pruritus ^† 1	0/6 (0.00%)	0	14/20 (70.00%)	17
Injection site erythema ^† 1	0/6 (0.00%)	0	8/20 (40.00%)	8
Injection site pain ^† 1	0/6 (0.00%)	0	2/20 (10.00%)	2
Feeling hot ^† 1	0/6 (0.00%)	0	1/20 (5.00%)	1
Injection site reaction ^† 1	0/6 (0.00%)	0	1/20 (5.00%)	1
Colitis ulcerative ^† 1	0/6 (0.00%)	0	1/20 (5.00%)	1
Infections and infestations
Fungal infection ^† 1	0/6 (0.00%)	0	2/20 (10.00%)	2
Influenza ^† 1	0/6 (0.00%)	0	1/20 (5.00%)	1
Nasopharyngitis ^† 1	0/6 (0.00%)	0	1/20 (5.00%)	1
Parynchia ^† 1	0/6 (0.00%)	0	1/20 (5.00%)	1
Pneumonia ^† 1	0/6 (0.00%)	0	1/20 (5.00%)	1
Sinusitis ^† 1	0/6 (0.00%)	0	1/20 (5.00%)	1
Urinary tract infection ^† 1	0/6 (0.00%)	0	1/20 (5.00%)	1
Injury, poisoning and procedural complications
Wrist Fracture ^† 1	1/6 (16.67%)	1	0/20 (0.00%)	0
Bone fissure ^† 1	0/6 (0.00%)	0	1/20 (5.00%)	1
Wound ^† 1	0/6 (0.00%)	0	1/20 (5.00%)	1
Investigations
Serum ferritin descreased ^† 1	0/6 (0.00%)	0	1/20 (5.00%)	1
Viral load increased ^† 1	0/6 (0.00%)	0	1/20 (5.00%)	1
Metabolism and nutrition disorders
Decreased appetite ^† 1	1/6 (16.67%)	1	2/20 (10.00%)	2
Musculoskeletal and connective tissue disorders
Back pain ^† 1	0/6 (0.00%)	0	2/20 (10.00%)	2
Nervous system disorders
Burning sensation ^† 1	1/6 (16.67%)	2	0/20 (0.00%)	0
Dizziness ^† 1	1/6 (16.67%)	1	0/20 (0.00%)	0
Dysgeusia ^† 1	1/6 (16.67%)	1	0/20 (0.00%)	0
Head Discomfort ^† 1	1/6 (16.67%)	1	0/20 (0.00%)	0
Headache ^† 1	1/6 (16.67%)	1	4/20 (20.00%)	4
Parosmia ^† 1	1/6 (16.67%)	1	1/20 (5.00%)	1
Petit mal epilepsy ^† 1	0/6 (0.00%)	0	1/20 (5.00%)	1
Sensory disturbance ^† 1	0/6 (0.00%)	0	1/20 (5.00%)	1
Renal and urinary disorders
Pollakiuria ^† 1	0/6 (0.00%)	0	1/20 (5.00%)	1
Urethral discharge ^† 1	0/6 (0.00%)	0	1/20 (5.00%)	1
Respiratory, thoracic and mediastinal disorders
Cough ^† 1	0/6 (0.00%)	0	1/20 (5.00%)	1
Oropharyngeal pain ^† 1	0/6 (0.00%)	0	1/20 (5.00%)	1
Skin and subcutaneous tissue disorders
Alopecia ^† 1	0/6 (0.00%)	0	1/20 (5.00%)	1
Photosensitivity reaction ^† 1	0/6 (0.00%)	0	1/20 (5.00%)	1
Pruritus ^† 1	0/6 (0.00%)	0	1/20 (5.00%)	1
Surgical and medical procedures
Wisdom teeth removal ^† 1	0/6 (0.00%)	0	1/20 (5.00%)	1
† Indicates events were collected by systematic assessment 1 Term from vocabulary, MedDRA (17.0)

Limitations and Caveats

[Not Specified]

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 Sponsor (or designee) will prepare a final report on the study. The Investigator may not publish or present any information on this study without the express written approval of the Sponsor. Additionally, the Sponsor, may, for any reason, withhold approval for publication or presentation.

Results Point of Contact

Name/Title: Maja Sommerfelt

Organization: Bionor Pharma ASA

Phone: +4723010960

EMail: ms@bionorpharma.com

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

Leth S, Schleimann MH, Nissen SK, Højen JF, Olesen R, Graversen ME, Jørgensen S, Kjær AS, Denton PW, Mørk A, Sommerfelt MA, Krogsgaard K, Østergaard L, Rasmussen TA, Tolstrup M, Søgaard OS. Combined effect of Vacc-4x, recombinant human granulocyte macrophage colony-stimulating factor vaccination, and romidepsin on the HIV-1 reservoir (REDUC): a single-arm, phase 1B/2A trial. Lancet HIV. 2016 Oct;3(10):e463-72. doi: 10.1016/S2352-3018(16)30055-8. Epub 2016 Jul 7.

Søgaard OS, Graversen ME, Leth S, Olesen R, Brinkmann CR, Nissen SK, Kjaer AS, Schleimann MH, Denton PW, Hey-Cunningham WJ, Koelsch KK, Pantaleo G, Krogsgaard K, Sommerfelt M, Fromentin R, Chomont N, Rasmussen TA, Østergaard L, Tolstrup M. The Depsipeptide Romidepsin Reverses HIV-1 Latency In Vivo. PLoS Pathog. 2015 Sep 17;11(9):e1005142. doi: 10.1371/journal.ppat.1005142. eCollection 2015 Sep.

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

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