Vacc-4x + Lenalidomide vs. Vacc-4x +Placebo in HIV-1-infected Subjects on Antiretroviral Therapy (ART) (IMID)

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ClinicalTrials.gov Identifier: NCT01704781

Recruitment Status : Completed

First Posted : October 11, 2012

Results First Posted : March 8, 2017

Last Update Posted : March 8, 2017

View this study on Beta.ClinicalTrials.gov

Sponsor:

Collaborator:

Celgene Corporation

Information provided by (Responsible Party):

Bionor Immuno AS

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Supportive Care
Condition	HIV-1 Infection
Interventions	Drug: Lenalidomide Drug: Lenalidomide placebo Drug: Vacc-4X Drug: rhuGM-CSF
Enrollment	36

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	Part A: Lenalidomide 5 mg	Part A: Lenalidomide 10 mg	Part A: Lenalidopmide 25 mg	Part B: Lenalidomide	Part B: Lenalidomide Placebo
Arm/Group Description	Intradermal Vacc-4x (1.2 mg) given ...	Intradermal Vacc-4x (1.2 mg) given ...	Intradermal Vacc-4x (1.2 mg) given ...	Intradermal Vacc-4x (1.2 mg) given ...	Intradermal Vacc-4x (1.2 mg) given ...
Arm/Group Description	Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide 5 mg	Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide 10 mg	Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide 25 mg	Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide for 6 immunizations (visit 2, 3, 4, 5, 6 and 7) & lenalidomide (dose determined in Part A) two days prior to and at the day of immunization. Lenalidomide: In Part A a dose escalation design is used (2,5; 5; 10; 25 mg). Part B will use the dose confirmed by Part A Vacc-4X: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water. rhuGM-CSF: Granulocyte macrophage colony stimulating factor as a local adjuvant	Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide for 6 immunizations (visit 2, 3, 4, 5, 6 and 7) & lenalidomide placebo two days prior to and at the day of immunization. Lenalidomide placebo: Capsules are identical to the active Lenalidomide capsules used. Vacc-4X: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water. rhuGM-CSF: Granulocyte macrophage colony stimulating factor as a local adjuvant
Period Title: Overall Study
Started	3	3	6	12	12
Completed	3	3	6	12	12
Not Completed	0	0	0	0	0

Baseline Characteristics

Arm/Group Title		Part A: Lenalidomide 5 mg	Part A: Lenalidomide 10 mg	Part A: Lenalidopmide 25 mg	Part B: Lenalidomide	Part B: Lenalidomide Placebo	Total
Arm/Group Description		Intradermal Vacc-4x (1.2 mg) given ...	Intradermal Vacc-4x (1.2 mg) given ...	Intradermal Vacc-4x (1.2 mg) given ...	Intradermal Vacc-4x (1.2 mg) given ...	Intradermal Vacc-4x (1.2 mg) given ...	Total of all reporting groups
Arm/Group Description		Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide 5 mg	Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide 10 mg	Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide 25 mg	Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide for 6 immunizations (visit 2, 3, 4, 5, 6 and 7) & lenalidomide (dose determined in Part A) two days prior to and at the day of immunization. Lenalidomide: In Part A a dose escalation design is used (2,5; 5; 10; 25 mg). Part B will use the dose confirmed by Part A Vacc-4X: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water. rhuGM-CSF: Granulocyte macrophage colony stimulating factor as a local adjuvant	Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide for 6 immunizations (visit 2, 3, 4, 5, 6 and 7) & lenalidomide placebo two days prior to and at the day of immunization. Lenalidomide placebo: Capsules are identical to the active Lenalidomide capsules used. Vacc-4X: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water. rhuGM-CSF: Granulocyte macrophage colony stimulating factor as a local adjuvant	Total of all reporting groups
Overall Number of Baseline Participants		3	3	6	12	12	36
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	3 participants	3 participants	6 participants	12 participants	12 participants	36 participants
		43.7 (4.16)	35.7 (3.06)	46.2 (5.42)	44.4 (7.97)	41.5 (8.04)	42.9 (7.34)
Gender Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	3 participants	3 participants	6 participants	12 participants	12 participants	36 participants
	Female	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Male	3 100.0%	3 100.0%	6 100.0%	12 100.0%	12 100.0%	36 100.0%
Ethnicity (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	3 participants	3 participants	6 participants	12 participants	12 participants	36 participants
	Hispanic or Latino	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Not Hispanic or Latino	3 100.0%	3 100.0%	6 100.0%	12 100.0%	12 100.0%	36 100.0%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Race (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	3 participants	3 participants	6 participants	12 participants	12 participants	36 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Asian	0 0.0%	1 33.3%	0 0.0%	0 0.0%	1 8.3%	2 5.6%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Black or African American	0 0.0%	1 33.3%	0 0.0%	0 0.0%	0 0.0%	1 2.8%
	White	3 100.0%	1 33.3%	6 100.0%	12 100.0%	11 91.7%	33 91.7%
	More than one race	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
BMI Mean (Standard Deviation) Unit of measure: Kg/m^2
	Number Analyzed	3 participants	3 participants	6 participants	12 participants	12 participants	36 participants
		23.7 (2.32)	27.9 (7.65)	24.4 (1.75)	23.6 (3.85)	23.5 (3.44)	24.1 (3.74)

Outcome Measures

1.Primary Outcome


Title	Part A: To Establish Highest Tolerated Dose of Lenalidomide, Dose-Limiting Toxicity
Description	Number of participants in each of the three groups that experienced an...
Description	Number of participants in each of the three groups that experienced any dose-limiting toxicity.
Time Frame	31 days

Outcome Measure Data

Analysis Population Description

ITT analysis set was used.


Arm/Group Title	Part A: Lenalidomide 5 mg	Part A: Lenalidomide 10 mg	Part A: Lenalidopmide 25 mg
Arm/Group Description:	Intradermal Vacc-4x (1.2 mg) given ...	Intradermal Vacc-4x (1.2 mg) given ...	Intradermal Vacc-4x (1.2 mg) given ...
Arm/Group Description:	Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide 5 mg	Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide 10 mg	Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide 25 mg
Overall Number of Participants Analyzed	3	3	6
Measure Type: Count of Participants Unit of Measure: Participants
	0 0.0%	0 0.0%	0 0.0%

2.Primary Outcome


Title	Part A: To Establish Highest Tolerated Dose of Lenalidomide, CD4 Counts Over Time
Description	[Not Specified]
Description	[Not Specified]
Time Frame	31 days

Outcome Measure Data

Analysis Population Description

ITT analysis set was used.


Arm/Group Title	Part A: Lenalidomide 5 mg	Part A: Lenalidomide 10 mg	Part A: Lenalidopmide 25 mg
Arm/Group Description:	Intradermal Vacc-4x (1.2 mg) given ...	Intradermal Vacc-4x (1.2 mg) given ...	Intradermal Vacc-4x (1.2 mg) given ...
Arm/Group Description:	Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide 5 mg	Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide 10 mg	Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide 25 mg
Overall Number of Participants Analyzed	3	3	6
Mean (Standard Deviation) Unit of Measure: 10^6 cells/mL
Baseline	437.3 (38.30)	436.3 (60.05)	454.2 (86.59)
Week 1	393.0 (167.56)	317.0 (18.52)	342.2 (27.13)
Week 4	442.0 (121.77)	399.3 (15.95)	450.7 (147.02)
Week 5	432.7 (242.47)	449.0 (71.04)	452.3 (66.28)

3.Primary Outcome


Title	Part B: Change in CD4 Count
Description	Change in CD4 count from baseline to Week 26.
Description	Change in CD4 count from baseline to Week 26.
Time Frame	Week 26

Outcome Measure Data

Analysis Population Description

Analysis was performed for both the Intent To Treat (ITT) and Per Protocol (PP) analysis set.


Arm/Group Title		Part B: Lenalidomide	Part B: Lenalidomide Placebo
Arm/Group Description:		Intradermal Vacc-4x (1.2 mg) given ...	Intradermal Vacc-4x (1.2 mg) given ...
Arm/Group Description:		Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide for 6 immunizations (visit 2, 3, 4, 5, 6 and 7) & lenalidomide (dose determined in Part A) two days prior to and at the day of immunization. Lenalidomide: In Part A a dose escalation design is used (2,5; 5; 10; 25 mg). Part B will use the dose confirmed by Part A Vacc-4X: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water. rhuGM-CSF: Granulocyte macrophage colony stimulating factor as a local adjuvant	Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide for 6 immunizations (visit 2, 3, 4, 5, 6 and 7) & lenalidomide placebo two days prior to and at the day of immunization. Lenalidomide placebo: Capsules are identical to the active Lenalidomide capsules used. Vacc-4X: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water. rhuGM-CSF: Granulocyte macrophage colony stimulating factor as a local adjuvant
Overall Number of Participants Analyzed		12	12
Mean (Standard Deviation) Unit of Measure: 10^6 cells/L
ITT	Number Analyzed	12 participants	12 participants
ITT		90.9 (98.79)	42.2 (81.40)
PP	Number Analyzed	10 participants	11 participants
PP		106.3 (101.00)	49.1 (81.58)

4.Secondary Outcome


Title	Part B: Change in CD8 Count
Description	Change in CD8 count from baseline to week 26.
Description	Change in CD8 count from baseline to week 26.
Time Frame	26 weeks

Outcome Measure Data

Analysis Population Description

Not all patients had quantifiable blood samples/counts at all time points


Arm/Group Title		Part B: Lenalidomide	Part B: Lenalidomide Placebo
Arm/Group Description:		Intradermal Vacc-4x (1.2 mg) given ...	Intradermal Vacc-4x (1.2 mg) given ...
Arm/Group Description:		Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide for 6 immunizations (visit 2, 3, 4, 5, 6 and 7) & lenalidomide (dose determined in Part A) two days prior to and at the day of immunization. Lenalidomide: In Part A a dose escalation design is used (2,5; 5; 10; 25 mg). Part B will use the dose confirmed by Part A Vacc-4X: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water. rhuGM-CSF: Granulocyte macrophage colony stimulating factor as a local adjuvant	Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide for 6 immunizations (visit 2, 3, 4, 5, 6 and 7) & lenalidomide placebo two days prior to and at the day of immunization. Lenalidomide placebo: Capsules are identical to the active Lenalidomide capsules used. Vacc-4X: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water. rhuGM-CSF: Granulocyte macrophage colony stimulating factor as a local adjuvant
Overall Number of Participants Analyzed		12	12
Mean (Standard Deviation) Unit of Measure: 10^6 cells/L
Baseline	Number Analyzed	12 participants	12 participants
Baseline		734.2 (473.14)	655.3 (325.19)
Week 1	Number Analyzed	11 participants	10 participants
Week 1		653.8 (382.16)	784.5 (372.96)
Week 4	Number Analyzed	12 participants	11 participants
Week 4		744.9 (485.49)	794.5 (452.91)
Week 12	Number Analyzed	12 participants	12 participants
Week 12		823.0 (548.84)	760.3 (432.79)
Week 13	Number Analyzed	12 participants	11 participants
Week 13		811.2 (557.52)	663.6 (393.95)

5.Secondary Outcome


Title	Part B: Evaluate the Effect on HIV Viral Load
Description	Results BLQ (<20 HIV copies/mL) have been replaced with BLQ/2 = 10 ...
Description	Results BLQ (<20 HIV copies/mL) have been replaced with BLQ/2 = 10 HIV copies/mL while 'not detected' results have been replaced with 0 HIV copies/mL.
Time Frame	26 weeks

Outcome Measure Data

Analysis Population Description

ITT analysis set


Arm/Group Title		Part B: Lenalidomide	Part B: Lenalidomide Placebo
Arm/Group Description:		Intradermal Vacc-4x (1.2 mg) given ...	Intradermal Vacc-4x (1.2 mg) given ...
Arm/Group Description:		Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide for 6 immunizations (visit 2, 3, 4, 5, 6 and 7) & lenalidomide (dose determined in Part A) two days prior to and at the day of immunization. Lenalidomide: In Part A a dose escalation design is used (2,5; 5; 10; 25 mg). Part B will use the dose confirmed by Part A Vacc-4X: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water. rhuGM-CSF: Granulocyte macrophage colony stimulating factor as a local adjuvant	Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide for 6 immunizations (visit 2, 3, 4, 5, 6 and 7) & lenalidomide placebo two days prior to and at the day of immunization. Lenalidomide placebo: Capsules are identical to the active Lenalidomide capsules used. Vacc-4X: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water. rhuGM-CSF: Granulocyte macrophage colony stimulating factor as a local adjuvant
Overall Number of Participants Analyzed		12	12
Mean (Standard Deviation) Unit of Measure: Copies/mL
Baseline	Number Analyzed	12 participants	12 participants
Baseline		0.8 (2.89)	2.5 (4.52)
Week 1	Number Analyzed	12 participants	12 participants
Week 1		5.1 (9.30)	0.0 (0.00)
Week 4	Number Analyzed	12 participants	11 participants
Week 4		6.4 (8.17)	0.9 (3.02)
Week 12	Number Analyzed	12 participants	12 participants
Week 12		5.5 (11.29)	4.3 (6.90)
Week 13	Number Analyzed	12 participants	12 participants
Week 13		7.4 (19.77)	1.7 (3.89)
Week 21	Number Analyzed	12 participants	12 participants
Week 21		1.7 (3.89)	4.2 (5.15)
Week 26	Number Analyzed	12 participants	12 participants
Week 26		3.5 (6.99)	2.5 (4.52)

6.Secondary Outcome


Title	Part B: Incidents of Delayed-type Hypersensitivity
Description	Delayed-type hypersensitivity measured by induration and erythema.
Description	Delayed-type hypersensitivity measured by induration and erythema.
Time Frame	26 weeks

Outcome Measure Data

Analysis Population Description

The IIT population was used for this outcome measure. Data for one patient was not reported at week 26.


Arm/Group Title		Part B: Lenalidomide	Part B: Lenalidomide Placebo
Arm/Group Description:		Intradermal Vacc-4x (1.2 mg) given ...	Intradermal Vacc-4x (1.2 mg) given ...
Arm/Group Description:		Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide for 6 immunizations (visit 2, 3, 4, 5, 6 and 7) & lenalidomide (dose determined in Part A) two days prior to and at the day of immunization. Lenalidomide: In Part A a dose escalation design is used (2,5; 5; 10; 25 mg). Part B will use the dose confirmed by Part A Vacc-4X: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water. rhuGM-CSF: Granulocyte macrophage colony stimulating factor as a local adjuvant	Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide for 6 immunizations (visit 2, 3, 4, 5, 6 and 7) & lenalidomide placebo two days prior to and at the day of immunization. Lenalidomide placebo: Capsules are identical to the active Lenalidomide capsules used. Vacc-4X: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water. rhuGM-CSF: Granulocyte macrophage colony stimulating factor as a local adjuvant
Overall Number of Participants Analyzed		12	12
Measure Type: Count of Participants Unit of Measure: Participants
Week 1, Induration	Number Analyzed	12 participants	12 participants
Week 1, Induration		0 0.0%	0 0.0%
Week 1, Erythema	Number Analyzed	12 participants	12 participants
Week 1, Erythema		0 0.0%	1 8.3%
Week 26, Induration	Number Analyzed	11 participants	11 participants
Week 26, Induration		5 45.5%	2 18.2%
Week 26, Erythema	Number Analyzed	11 participants	11 participants
Week 26, Erythema		6 54.5%	6 54.5%

7.Secondary Outcome


Title	Part A and B: Safety and Tolerability
Description	[Not Specified]
Description	[Not Specified]
Time Frame	Part A: 31 days and Part B: 26 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Part A: Lenalidomide 5 mg	Part A: Lenalidomide 10 mg	Part A: Lenalidopmide 25 mg	Part B: Lenalidomide	Part B: Lenalidomide Placebo
Arm/Group Description:	Intradermal Vacc-4x (1.2 mg) given ...	Intradermal Vacc-4x (1.2 mg) given ...	Intradermal Vacc-4x (1.2 mg) given ...	Intradermal Vacc-4x (1.2 mg) given ...	Intradermal Vacc-4x (1.2 mg) given ...
Arm/Group Description:	Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide 5 mg	Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide 10 mg	Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide 25 mg	Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide for 6 immunizations (visit 2, 3, 4, 5, 6 and 7) & lenalidomide (dose determined in Part A) two days prior to and at the day of immunization. Lenalidomide: In Part A a dose escalation design is used (2,5; 5; 10; 25 mg). Part B will use the dose confirmed by Part A Vacc-4X: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water. rhuGM-CSF: Granulocyte macrophage colony stimulating factor as a local adjuvant	Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide for 6 immunizations (visit 2, 3, 4, 5, 6 and 7) & lenalidomide placebo two days prior to and at the day of immunization. Lenalidomide placebo: Capsules are identical to the active Lenalidomide capsules used. Vacc-4X: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water. rhuGM-CSF: Granulocyte macrophage colony stimulating factor as a local adjuvant
Overall Number of Participants Analyzed	3	3	6	12	12
Measure Type: Number Unit of Measure: participants
With any TEAE	3	2	6	10	9
With TESAE	0	0	0	1	0
With any AE resultiung in withdrawal	0	0	0	0	0
Deaths	0	0	0	0	0

Adverse Events

Time Frame	Adverse events were collected from the time of signing informed consent and until last visit; 31 days in Part A and 26 weeks in Part B. In addition, a 5-year survival follow-up period during which telephone contact from site for all subjects who discontinue treatment at any time will be conducted every 4 months for the first two years and every 6 months thereafter for a minimum of 5 years post-inclusion for survival, cause(s) of death, disease progression and post-treatment therapy(ies).
Adverse Event Reporting Description	[Not Specified]

Arm/Group Title	Part A: Lenalidomide 5 mg		Part A: Lenalidomide 10 mg		Part A: Lenalidopmide 25 mg		Part B: Lenalidomide		Part B: Lenalidomide Placebo
Arm/Group Description	Intradermal Vacc-4x (1.2 mg) given ...		Intradermal Vacc-4x (1.2 mg) given ...		Intradermal Vacc-4x (1.2 mg) given ...		Intradermal Vacc-4x (1.2 mg) given ...		Intradermal Vacc-4x (1.2 mg) given ...
Arm/Group Description	Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide 5 mg		Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide 10 mg		Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide 25 mg		Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide for 6 immunizations (visit 2, 3, 4, 5, 6 and 7) & lenalidomide (dose determined in Part A) two days prior to and at the day of immunization. Lenalidomide: In Part A a dose escalation design is used (2,5; 5; 10; 25 mg). Part B will use the dose confirmed by Part A Vacc-4X: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water. rhuGM-CSF: Granulocyte macrophage colony stimulating factor as a local adjuvant		Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide for 6 immunizations (visit 2, 3, 4, 5, 6 and 7) & lenalidomide placebo two days prior to and at the day of immunization. Lenalidomide placebo: Capsules are identical to the active Lenalidomide capsules used. Vacc-4X: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water. rhuGM-CSF: Granulocyte macrophage colony stimulating factor as a local adjuvant
All-Cause Mortality
	Part A: Lenalidomide 5 mg		Part A: Lenalidomide 10 mg		Part A: Lenalidopmide 25 mg		Part B: Lenalidomide		Part B: Lenalidomide Placebo
	Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)
Total	--/--		--/--		--/--		--/--		--/--
Serious Adverse Events Serious Adverse Events
	Part A: Lenalidomide 5 mg		Part A: Lenalidomide 10 mg		Part A: Lenalidopmide 25 mg		Part B: Lenalidomide		Part B: Lenalidomide Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/3 (0.00%)		0/3 (0.00%)		0/6 (0.00%)		1/12 (8.33%)		0/12 (0.00%)
Infections and infestations
Abscess left upper arm ^† 1	0/3 (0.00%)	0	0/3 (0.00%)	0	0/6 (0.00%)	0	1/12 (8.33%)	1	0/12 (0.00%)	0
† Indicates events were collected by systematic assessment 1 Term from vocabulary, medDRA 15.0
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Part A: Lenalidomide 5 mg		Part A: Lenalidomide 10 mg		Part A: Lenalidopmide 25 mg		Part B: Lenalidomide		Part B: Lenalidomide Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/3 (100.00%)		2/3 (66.67%)		6/6 (100.00%)		10/12 (83.33%)		9/12 (75.00%)
Blood and lymphatic system disorders
Lymphadenopathy ^† 1	0/3 (0.00%)	0	0/3 (0.00%)	0	0/6 (0.00%)	0	1/12 (8.33%)	1	1/12 (8.33%)	2
Ear and labyrinth disorders
Tinnitus ^† 1	0/3 (0.00%)	0	0/3 (0.00%)	0	0/6 (0.00%)	0	1/12 (8.33%)	1	0/12 (0.00%)	0
Endocrine disorders
Hypogonadism ^† 1	0/3 (0.00%)	0	0/3 (0.00%)	0	0/6 (0.00%)	0	1/12 (8.33%)	1	0/12 (0.00%)	0
Eye disorders
Conjunctivitis allergic ^† 1	0/3 (0.00%)	0	0/3 (0.00%)	0	0/6 (0.00%)	0	1/12 (8.33%)	1	0/12 (0.00%)	0
Gastrointestinal disorders
Diarrhoea ^† 1	0/3 (0.00%)	0	0/3 (0.00%)	0	0/6 (0.00%)	0	1/12 (8.33%)	1	1/12 (8.33%)	1
Nausea ^† 1	0/3 (0.00%)	0	0/3 (0.00%)	0	0/6 (0.00%)	0	1/12 (8.33%)	1	1/12 (8.33%)	2
Abdominnal pain upper ^† 1	0/3 (0.00%)	0	0/3 (0.00%)	0	0/6 (0.00%)	0	1/12 (8.33%)	1	0/12 (0.00%)	0
Abdominal tenderness ^† 1	0/3 (0.00%)	0	0/3 (0.00%)	0	0/6 (0.00%)	0	1/12 (8.33%)	1	0/12 (0.00%)	0
Colitis ^† 1	0/3 (0.00%)	0	0/3 (0.00%)	0	0/6 (0.00%)	0	1/12 (8.33%)	1	0/12 (0.00%)	0
Dry mouth ^† 1	0/3 (0.00%)	0	0/3 (0.00%)	0	1/6 (16.67%)	1	0/12 (0.00%)	0	0/12 (0.00%)	0
General disorders
Fatigue ^† 1	1/3 (33.33%)	1	0/3 (0.00%)	0	1/6 (16.67%)	1	2/12 (16.67%)	2	4/12 (33.33%)	6
Injection site erythema ^† 1	2/3 (66.67%)	4	1/3 (33.33%)	4	2/6 (33.33%)	2	4/12 (33.33%)	6	2/12 (16.67%)	3
Injection site pruritus ^† 1	2/3 (66.67%)	4	0/3 (0.00%)	0	1/6 (16.67%)	1	3/12 (25.00%)	4	2/12 (16.67%)	2
Injection site swelling ^† 1	1/3 (33.33%)	3	1/3 (33.33%)	1	0/6 (0.00%)	0	2/12 (16.67%)	4	0/12 (0.00%)	0
Injection site induration ^† 1	1/3 (33.33%)	1	0/3 (0.00%)	0	0/6 (0.00%)	0	1/12 (8.33%)	1	0/12 (0.00%)	0
Injection site pain ^† 1	1/3 (33.33%)	2	0/3 (0.00%)	0	0/6 (0.00%)	0	1/12 (8.33%)	1	2/12 (16.67%)	2
Injection site warmth ^† 1	1/3 (33.33%)	1	0/3 (0.00%)	0	0/6 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0
Application site pruritus ^† 1	0/3 (0.00%)	0	0/3 (0.00%)	0	0/6 (0.00%)	0	2/12 (16.67%)	2	1/12 (8.33%)	1
Application site erythema ^† 1	0/3 (0.00%)	0	0/3 (0.00%)	0	0/6 (0.00%)	0	1/12 (8.33%)	1	0/12 (0.00%)	0
Influenza like illness ^† 1	0/3 (0.00%)	0	0/3 (0.00%)	0	1/6 (16.67%)	3	2/12 (16.67%)	6	1/12 (8.33%)	1
Chest pain ^† 1	0/3 (0.00%)	0	0/3 (0.00%)	0	1/6 (16.67%)	1	0/12 (0.00%)	0	0/12 (0.00%)	0
Asthenia ^† 1	0/3 (0.00%)	0	0/3 (0.00%)	0	0/6 (0.00%)	0	1/12 (8.33%)	2	0/12 (0.00%)	0
Swelling ^† 1	0/3 (0.00%)	0	0/3 (0.00%)	0	0/6 (0.00%)	0	1/12 (8.33%)	1	0/12 (0.00%)	0
Hepatobiliary disorders
Hypertransaminasaemia ^† 1	0/3 (0.00%)	0	0/3 (0.00%)	0	0/6 (0.00%)	0	1/12 (8.33%)	1	0/12 (0.00%)	0
Immune system disorders
Hypersensitivity ^† 1	0/3 (0.00%)	0	0/3 (0.00%)	0	0/6 (0.00%)	0	1/12 (8.33%)	1	0/12 (0.00%)	0
Seasonal allergy ^† 1	0/3 (0.00%)	0	0/3 (0.00%)	0	0/6 (0.00%)	0	1/12 (8.33%)	1	0/12 (0.00%)	0
Infections and infestations
Nasopharyngitis ^† 1	0/3 (0.00%)	0	0/3 (0.00%)	0	1/6 (16.67%)	1	2/12 (16.67%)	2	0/12 (0.00%)	0
Rhinitis ^† 1	0/3 (0.00%)	0	0/3 (0.00%)	0	0/6 (0.00%)	0	1/12 (8.33%)	1	1/12 (8.33%)	1
Abscess limb ^† 1	0/3 (0.00%)	0	0/3 (0.00%)	0	0/6 (0.00%)	0	1/12 (8.33%)	1	0/12 (0.00%)	0
Bronchitis ^† 1	0/3 (0.00%)	0	0/3 (0.00%)	0	0/6 (0.00%)	0	1/12 (8.33%)	1	0/12 (0.00%)	0
Chlamydial infection ^† 1	0/3 (0.00%)	0	0/3 (0.00%)	0	0/6 (0.00%)	0	1/12 (8.33%)	1	0/12 (0.00%)	0
Folliculitis ^† 1	0/3 (0.00%)	0	0/3 (0.00%)	0	0/6 (0.00%)	0	1/12 (8.33%)	1	0/12 (0.00%)	0
Gastroenteritis ^† 1	0/3 (0.00%)	0	0/3 (0.00%)	0	0/6 (0.00%)	0	1/12 (8.33%)	1	0/12 (0.00%)	0
Herpes zoster ^† 1	0/3 (0.00%)	0	0/3 (0.00%)	0	0/6 (0.00%)	0	1/12 (8.33%)	1	0/12 (0.00%)	0
Tooth infection ^† 1	0/3 (0.00%)	0	1/3 (33.33%)	1	0/6 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1
Sunisitis ^† 1	0/3 (0.00%)	0	1/3 (33.33%)	1	0/6 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0
Injury, poisoning and procedural complications
Injection related reaction ^† 1	0/3 (0.00%)	0	0/3 (0.00%)	0	0/6 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1
Musculoskeletal and connective tissue disorders
Arthralgia ^† 1	0/3 (0.00%)	0	0/3 (0.00%)	0	0/6 (0.00%)	0	1/12 (8.33%)	1	2/12 (16.67%)	3
Groin pain ^† 1	0/3 (0.00%)	0	0/3 (0.00%)	0	0/6 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1
Pain in extremity ^† 1	0/3 (0.00%)	0	0/3 (0.00%)	0	0/6 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1
Nervous system disorders
Autonomic nervous system imbalance ^† 1	0/3 (0.00%)	0	0/3 (0.00%)	0	0/6 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1
Cerebral atrophy ^† 1	0/3 (0.00%)	0	0/3 (0.00%)	0	0/6 (0.00%)	0	1/12 (8.33%)	1	0/12 (0.00%)	0
Facial paresis ^† 1	0/3 (0.00%)	0	0/3 (0.00%)	0	0/6 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1
Grand mal convultion ^† 1	0/3 (0.00%)	0	0/3 (0.00%)	0	0/6 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1
Headache ^† 1	1/3 (33.33%)	1	1/3 (33.33%)	1	1/6 (16.67%)	1	1/12 (8.33%)	1	0/12 (0.00%)	0
Paraesthesia ^† 1	0/3 (0.00%)	0	0/3 (0.00%)	0	1/6 (16.67%)	1	0/12 (0.00%)	0	1/12 (8.33%)	1
Psychiatric disorders
Aggression ^† 1	0/3 (0.00%)	0	0/3 (0.00%)	0	0/6 (0.00%)	0	1/12 (8.33%)	1	0/12 (0.00%)	0
Listless ^† 1	1/3 (33.33%)	1	0/3 (0.00%)	0	0/6 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0
Skin and subcutaneous tissue disorders
Erythema ^† 1	0/3 (0.00%)	0	0/3 (0.00%)	0	0/6 (0.00%)	0	3/12 (25.00%)	3	0/12 (0.00%)	0
Pruritus ^† 1	0/3 (0.00%)	0	0/3 (0.00%)	0	2/6 (33.33%)	3	3/12 (25.00%)	5	0/12 (0.00%)	0
Pruritus generalized ^† 1	1/3 (33.33%)	1	0/3 (0.00%)	0	0/6 (0.00%)	0	1/12 (8.33%)	2	0/12 (0.00%)	0
Angioedema ^† 1	0/3 (0.00%)	0	0/3 (0.00%)	0	1/6 (16.67%)	1	1/12 (8.33%)	1	0/12 (0.00%)	0
Rash ^† 1	0/3 (0.00%)	0	0/3 (0.00%)	0	0/6 (0.00%)	0	3/12 (25.00%)	6	0/12 (0.00%)	0
Actinic keratosis ^† 1	0/3 (0.00%)	0	0/3 (0.00%)	0	0/6 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1
Scab ^† 1	0/3 (0.00%)	0	0/3 (0.00%)	0	0/6 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1
Skin lesion ^† 1	0/3 (0.00%)	0	0/3 (0.00%)	0	0/6 (0.00%)	0	1/12 (8.33%)	1	0/12 (0.00%)	0
Vascular disorders
Flushing ^† 1	0/3 (0.00%)	0	0/3 (0.00%)	0	1/6 (16.67%)	1	0/12 (0.00%)	0	0/12 (0.00%)	0
Hypertension ^† 1	0/3 (0.00%)	0	0/3 (0.00%)	0	0/6 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1
† Indicates events were collected by systematic assessment 1 Term from vocabulary, medDRA 15.0

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

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Name/Title:	Maja Sommerfelt
Organization:	Bionor Pharma ASA
Phone:	+4723010960
EMail:	ms@bionorpharma.com

Publications:

Asjo B, Stavang H, Sorensen B, Baksaas I, Nyhus J, Langeland N. Phase I trial of a therapeutic HIV type 1 vaccine, Vacc-4x, in HIV type 1-infected individuals with or without antiretroviral therapy. AIDS Res Hum Retroviruses. 2002 Dec 10;18(18):1357-65. doi: 10.1089/088922202320935438.

Kran AM, Sorensen B, Nyhus J, Sommerfelt MA, Baksaas I, Bruun JN, Kvale D. HLA- and dose-dependent immunogenicity of a peptide-based HIV-1 immunotherapy candidate (Vacc-4x). AIDS. 2004 Sep 24;18(14):1875-83. doi: 10.1097/00002030-200409240-00003.

Kvale D, Kran AM, Sommerfelt MA, Nyhus J, Baksaas I, Bruun JN, Sorensen B. Divergent in vitro and in vivo correlates of HIV-specific T-cell responses during onset of HIV viraemia. AIDS. 2005 Mar 24;19(6):563-7. doi: 10.1097/01.aids.0000163932.76531.c6.

Sommerfelt MA, Nyhus J, Sorensen B. Novel peptide-based HIV-1 immunotherapy. Expert Opin Biol Ther. 2004 Mar;4(3):349-61. doi: 10.1517/14712598.4.3.349.

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Responsible Party:	Bionor Immuno AS
ClinicalTrials.gov Identifier:	NCT01704781
Other Study ID Numbers:	CT-BI Vacc-4x/IMiD-2010/1
First Submitted:	September 11, 2012
First Posted:	October 11, 2012
Results First Submitted:	January 16, 2017
Results First Posted:	March 8, 2017
Last Update Posted:	March 8, 2017

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