HIV-1 InfectionPhase 1/2IMIDNCT01704781

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

A Phase 1/2 study testing Lenalidomide, Vacc-4X and rhuGM-CSF in people with HIV-1 Infection, run by Bionor Immuno AS at 4 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

During the course of HIV infection the number of CD4 cells decreases, resulting in a reduced immunological response and ultimately immune deficiency. Vacc-4x is a peptide-based HIV immunotherapy and the primary objective is to strengthen the immune system's response to HIV p24. Read more about this study

Who is it for?: Ages 18 to 55 years
Conditions the study is for: HIV-1 Infection
What is being tested?: Lenalidomide, Vacc-4X and rhuGM-CSF
Type of treatment: Vaccines, Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 36 participants
Where: 4 sitesGermany
Study dates: Sep 2012to Aug 2014
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Men, age ≥ 18 and ≤ 55 years at the time of screening.
Women, age ≥ 50 and ≤ 55 years at the time of screening, who are not of childbearing potential (see Exclusion criteria, point 9). Childbearing status must be documented.
Clinically stable on ART for the last 18 months (changes in therapy are allowed as long as the viral load is stable).
Well controlled with no treatment failure due to ART resistance in the past
Screening plasma viral load (HIV-1 RNA) less than 50 copies/mL for the last six months. If screening value is between 50-500 copies/mL rescreening is allowed. Single blips (up to 500 copies/mL) are allowed.
Screening CD4 cell count ≥ 200x10^6 cells/L and ≤500x10^6 cells/L. (Rescreening is allowed)

Show all 9Show fewer

Laboratory test results within these ranges: Absolute neutrophil count (ANC) >1.0x10^9 /L, Platelet count >75x10^9 /L and eGRF (MDRD) >60 mL/min
Signed informed consent
Willingness to adhere to Global Pregnancy Prevention Risk Management Plan Lenalidomide

Who cannot join

Reported pre-study AIDS-defining illness within the previous year
Malignant disease.
On chronic treatment with immunosuppressive therapy.
Autoimmune disorders, present or in the past if there is an increased risk of disease exacerbation.
Unacceptable values of the hematologic and clinical chemistry parameters (including those associated with hemophilia), as judged by the Investigator or the Sponsor (or designee), including creatinine values >1.5x upper limit of normal (ULN), and AST (SGOT), ALT (SGPT), and alkaline phosphatase values >2.5x ULN.
Concurrent chronic active infection such as viral hepatitis B or C or tuberculosis.

Show all 12Show fewer

Previous thromboembolic events or patient is currently immobilized
Sexually active subjects who do not adhere to Global Pregnancy Prevention Risk Management Plan Lenalidomide
Current participation in other clinical therapeutic studies.
Females of childbearing potential will be excluded from this trial. A female of childbearing potential (FCBP) is a sexually mature female who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e. has had menses at any time in the preceding 24 consecutive months).
The development of erythema nodosum if characterized by a desquamating rash while previously
Incapability of compliance to the treatment protocol, in the opinion of the Investigator.

Trial locations and contacts

4 sites in 1 country.

Germany4 sites

EIPMED - Gesellschaft fűr epidemiologische und klinische Forschung in der Medizin mbH Rubensstrasse 125
Berlin, State of Berlin, 12157
Charite Campus, Virchow-Klinikum Medizinische Klinik mit Schwerpunkt Infektiologie Station 59 (Suedring 11) Augustenburger Platz 1
Berlin, State of Berlin, 13353
Klinik I für Innere Medizin Klinikum Der Universität zu Köln
Cologne, 50937
University Medical Center Hamburg-Eppendorf
Hamburg, Free and Hanseatic City of Hamburg, 20246

Other trials in Germany

About this study

Official title: A Double-blind Placebo Controlled Immunogenicity Study of Vacc-4x + Lenalidomide Versus Vacc-4x With an Initial Open-label Dose Escalation Assessment of Lenalidomide in HIV-1-infected Subjects on Antiretroviral Therapy (ART).

Read the detailed description

Human immunodeficiency virus (HIV) infects the CD4 subset of T-cells that are critical for initiating immune responses to infection. The level of CD4 cells in the blood is a marker of a patient's immunological status. The number of CD4 cells decreases in the course of the HIV infection and results in a reduced immunological response and eventually immune deficiency.

Vacc-4x is one of the few peptide-based therapeutic vaccines tested, and consists of four, slightly modified HIV Gag p24 consensus peptides. Vacc-4x was first tested by intradermal injections using GM-CSF as adjuvant. A recent multinational placebo-controlled study found improvement of vaccine-specific T cell immunity and decrease in viral loads (presented at the AIDS vaccine 2011 conference, Bangkok).

Lenalidomide (CC-5013) is a substance in the class of immunomodulatory agents. The lenalidomide mechanism of action includes anti-neoplastic, pro-erythropoietic, and immunomodulatory properties. Lenalidomide inhibits proliferation of certain hematopoietic tumor cells, enhances T cell- and Natural Killer (NK) cell-mediated immunity and increases the number of NK T cells.

The anti-HIV p24 immune response resulting from Vacc-4x immunization could in combination with ART potentially improve immune reconstitution in patients who have not fully regained a healthy CD4 level (> 600 x106/L). Adding the immunomodulatory agent Lenalidomide (CC-5013) to Vacc-4x immunization could enhance the immune response to Vacc-4x and further strengthen immune reconstitution.

Conditions: HIV-1 Infection
Being tested: Lenalidomide, Lenalidomide placebo, Vacc-4X, rhuGM-CSF
Keywords: CD4, Clinical trial, Dose escalation assessment lenalidomide, Human immunodeficiency virus-1 (HIV-1), HIV, Immunomodulatory, Infection, Lenalidomide, Phase I/II, Vaccine, Vacc-4x
Medical subject headings: Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LenalidomideDrug
Also called Lenalidomide capsule
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
Lenalidomide placeboDrug
Also called placebo
Capsules are identical to the active Lenalidomide capsules used.
Vacc-4XDrug
Also called Combination of Vacc-10, Vacc-11, Vacc-12 and Vacc-13.
Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water.
rhuGM-CSFDrug
Also called Leukine®
Granulocyte macrophage colony stimulating factor as a local adjuvant

Study groups in NCT01704781
Study group	Role	What they receive
Part A: lenalidomide dose escalation	Experimental	All patient receive intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide in a dose escalation (3+3) design. Dose level -1: 2.5 mg Lenalidomide (CC-5013) in the event Dose level 1 is non tolerated dose (NTD) Dose level 1(start): 5 mg Lenalidomide (CC-5013) Dose level 2: 10 mg Lenalidomide (CC-5013) Dose level 3: 25 mg Lenalidomide (CC-5013) Receives: Drug: Lenalidomide; Drug: Vacc-4X; Drug: rhuGM-CSF
Part B: lenalidomide	Experimental	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. Receives: Drug: Lenalidomide; Drug: Vacc-4X; Drug: rhuGM-CSF
Part B: lenalidomide placebo	Placebo comparator	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. Receives: Drug: Lenalidomide placebo; Drug: Vacc-4X; Drug: rhuGM-CSF

What is being measured

The primary outcome is the main question the study is designed to answer.

Part A: To Establish Highest Tolerated Dose of Lenalidomide, Dose-Limiting Toxicity
Number of participants in each of the three groups that experienced any dose-limiting toxicity.
Measured: 31 days
Part A: To Establish Highest Tolerated Dose of Lenalidomide, CD4 Counts Over Time
Measured: 31 days
Part B: Change in CD4 Count
Change in CD4 count from baseline to Week 26.
Measured: Week 26

Secondary outcomes (4)

Part B: Change in CD8 Count
Change in CD8 count from baseline to week 26.
Measured: 26 weeks
Part B: Evaluate the Effect on HIV Viral Load
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.
Measured: 26 weeks
Part B: Incidents of Delayed-type Hypersensitivity
Delayed-type hypersensitivity measured by induration and erythema.
Measured: 26 weeks
Part A and B: Safety and Tolerability
Measured: Part A: 31 days and Part B: 26 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2012Aug 2014

First posted11 Oct 2012 (estimated)
Study startSep 2012
Primary completionAug 2014
Study completionAug 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for HIV-1 InfectionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01704781
Sponsor's protocol ID: CT-BI Vacc-4x/IMiD-2010/1
Acronym: IMID
Status last verified: Oct 2014
First submitted: 11 Sep 2012
Last updated: 8 Mar 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No: Participants have not provided informed consent for their anonymized individual data to be made available beyond that described in the patient information sheet.

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.
PubMed 12487807
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.
PubMed 15353973
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.
PubMed 15802974
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.
PubMed 15006729

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Cohort of Women Living With HIV-1 and Receiving Bictegravir/Emtricitabine/Tenofovir Alafenamide
HIV (Human Immunodeficiency Virus), Pregnancy
RecruitingPhase 4
A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments
HIV-1-infection
RecruitingObservational study
Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Antiretroviral Naive HIV-1 Research Participants
HIV
Active, not recruitingPhase 3
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With Biktarvy
HIV-1-infection
Active, not recruitingPhase 2/3
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen (ARTISTRY-1)
HIV-1-infection

All HIV-1 Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double-blind Placebo Controlled Immunogenicity Study of Vacc-4x + Lenalidomide Versus Vacc-4x With an Initial Open-label Dose Escalation Assessment of Lenalidomide in HIV-1-infected Subjects on Antiretroviral Therapy (ART).
ClinicalTrials.gov ID: NCT01704781
Acronym / sponsor ID: IMID / CT-BI Vacc-4x/IMiD-2010/1
Conditions: HIV-1 Infection
Keywords: CD4, Clinical trial, Dose escalation assessment lenalidomide, Human immunodeficiency virus-1 (HIV-1), HIV, Immunomodulatory, Infection, Lenalidomide
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: Bionor Immuno ASIndustry (pharma, biotech, devices)
Collaborators: Celgene Corporation
Study start: Sep 2012
Primary completion: Aug 2014 (actual)
Study completion: Aug 2014 (actual)
First posted: 11 Oct 2012 (estimated)
Results: Posted 8 Mar 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Part A: lenalidomide dose escalation	Experimental	Drug: Lenalidomide, Drug: Vacc-4X, Drug: rhuGM-CSFAll patient receive intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide in a dose escalation (3+3) design. Dose level -1: 2.5 mg Lenalidomide (CC-5013) in the event Dose level 1 is non tolerated dose (NTD) Dose level 1(start): 5 mg Lenalidomide (CC-5013) Dose level 2: 10 mg Lenalidomide (CC-5013) Dose level 3: 25 mg Lenalidomide (CC-5013)
Part B: lenalidomide	Experimental	Drug: Lenalidomide, Drug: Vacc-4X, Drug: rhuGM-CSFIntradermal 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.
Part B: lenalidomide placebo	Placebo comparator	Drug: Lenalidomide placebo, Drug: Vacc-4X, Drug: rhuGM-CSFIntradermal 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.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (9 listed)

Men, age ≥ 18 and ≤ 55 years at the time of screening.
Women, age ≥ 50 and ≤ 55 years at the time of screening, who are not of childbearing potential (see Exclusion criteria, point 9). Childbearing status must be documented.
Clinically stable on ART for the last 18 months (changes in therapy are allowed as long as the viral load is stable).
Well controlled with no treatment failure due to ART resistance in the past
Screening plasma viral load (HIV-1 RNA) less than 50 copies/mL for the last six months. If screening value is between 50-500 copies/mL rescreening is allowed. Single blips (up to 500 copies/mL) are allowed.

Key exclusion criteria (12 listed)

Reported pre-study AIDS-defining illness within the previous year
Malignant disease.
On chronic treatment with immunosuppressive therapy.
Autoimmune disorders, present or in the past if there is an increased risk of disease exacerbation.
Unacceptable values of the hematologic and clinical chemistry parameters (including those associated with hemophilia), as judged by the Investigator or the Sponsor (or designee), including creatinine values >1.5x upper limit of normal (ULN), and AST (SGOT), ALT (SGPT), and alkaline phosphatase values >2.5x ULN.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LenalidomideAlso: Lenalidomide capsuleIn Part A a dose escalation design is used (2,5; 5; 10; 25 mg). Part B will use the dose confirmed by Part A	Drug	Part A: lenalidomide dose escalation, Part B: lenalidomide
Lenalidomide placeboAlso: placeboCapsules are identical to the active Lenalidomide capsules used.	Drug	Part B: lenalidomide placebo
Vacc-4XAlso: Combination of Vacc-10, Vacc-11, Vacc-12 and Vacc-13.Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water.	Drug	Part A: lenalidomide dose escalation, Part B: lenalidomide, Part B: lenalidomide placebo
rhuGM-CSFAlso: Leukine®Granulocyte macrophage colony stimulating factor as a local adjuvant	Drug	Part A: lenalidomide dose escalation, Part B: lenalidomide, Part B: lenalidomide placebo

Primary outcome

Part A: To Establish Highest Tolerated Dose of Lenalidomide, Dose-Limiting Toxicity
Time frame: 31 days
Number of participants in each of the three groups that experienced any dose-limiting toxicity.
Part A: To Establish Highest Tolerated Dose of Lenalidomide, CD4 Counts Over Time
Time frame: 31 days
Part B: Change in CD4 Count
Time frame: Week 26
Change in CD4 count from baseline to Week 26.

4 secondary outcomes

Part B: Change in CD8 Count
Time frame: 26 weeks
Part B: Evaluate the Effect on HIV Viral Load
Time frame: 26 weeks
Part B: Incidents of Delayed-type Hypersensitivity
Time frame: 26 weeks
Part A and B: Safety and Tolerability
Time frame: Part A: 31 days and Part B: 26 weeks

Results and safety

Results posted to the registry on 8 Mar 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Part A: Lenalidomide 5 mg	3	3
Part A: Lenalidomide 10 mg	3	3
Part A: Lenalidopmide 25 mg	6	6
Part B: Lenalidomide	12	12
Part B: Lenalidomide Placebo	12	12

Primary outcome: Part A: To Establish Highest Tolerated Dose of Lenalidomide, Dose-Limiting Toxicity

Time frame: 31 days. Count of participants. Unit: Participants

Measure	Part A: Lenalidomide 5 mg n = 3	Part A: Lenalidomide 10 mg n = 3	Part A: Lenalidopmide 25 mg n = 6
Value	0	0	0

Population analysed: ITT analysis set was used.

Primary outcome: Part A: To Establish Highest Tolerated Dose of Lenalidomide, CD4 Counts Over Time

Time frame: 31 days. Mean (Standard Deviation). Unit: 10^6 cells/mL

Measure	Part A: Lenalidomide 5 mg n = 3	Part A: Lenalidomide 10 mg n = 3	Part A: Lenalidopmide 25 mg n = 6
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)

Population analysed: ITT analysis set was used.

Primary outcome: Part B: Change in CD4 Count

Time frame: Week 26. Mean (Standard Deviation). Unit: 10^6 cells/L

Measure	Part B: Lenalidomide n = 12	Part B: Lenalidomide Placebo n = 12
ITT	90.9 (98.79)	42.2 (81.40)
PP	106.3 (101.00)	49.1 (81.58)

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

4 secondary outcomes are reported in the full results.

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).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Part A: Lenalidomide 5 mg	0 of 3 (0%)	3 of 3 (100%)	Not reported
Part A: Lenalidomide 10 mg	0 of 3 (0%)	2 of 3 (66.7%)	Not reported
Part A: Lenalidopmide 25 mg	0 of 6 (0%)	6 of 6 (100%)	Not reported
Part B: Lenalidomide	1 of 12 (8.3%)	10 of 12 (83.3%)	Not reported
Part B: Lenalidomide Placebo	0 of 12 (0%)	9 of 12 (75%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 12487807Asjo 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.
Background: PubMed 15353973Kran 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.
Background: PubMed 15802974Kvale 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.
Background: PubMed 15006729Sommerfelt 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.
Individual participant dataSharing planned: No. Participants have not provided informed consent for their anonymized individual data to be made available beyond that described in the patient information sheet.

Related trials for HIV-1 Infection

RecruitingObservational study
Cohort of Women Living With HIV-1 and Receiving Bictegravir/Emtricitabine/Tenofovir Alafenamide
HIV (Human Immunodeficiency Virus), Pregnancy
RecruitingPhase 4
A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments
HIV-1-infection
RecruitingObservational study
Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Antiretroviral Naive HIV-1 Research Participants
HIV
Active, not recruitingPhase 3
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With Biktarvy
HIV-1-infection
Active, not recruitingPhase 2/3
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen (ARTISTRY-1)
HIV-1-infection

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kim Krogsgaard study director

Bionor Pharma ASA, Kronprinsesse Märthas Plass 1, P.O. Box 1477 Vika, NO-0116 Oslo, Norway

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Lenalidomide, Vacc-4X and rhuGM-CSF in people with HIV-1 Infection, run by Bionor Immuno AS at 4 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part A: To Establish Highest Tolerated Dose of Lenalidomide, Dose-Limiting Toxicity (time frame: 31 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01704781, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2017.