BIOSKILL: Studying Vacc-4x, an HIV therapeutic vaccine, an as-sessment of immune-mediated anti-viral effects, when administered with adjuvant GM-CSF prior to HIV latent reservoir activation by the HDAC inhibitor, romidepsi

Phase 1

• Conditions: HIV infection; MedDRA version: 19.0 Level: PT Classification code 10020161 Term: HIV infection System Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2015-003186-28-DK
• Lead Sponsor: Bionor Pharma ASA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-11-25
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 192

Inclusion Criteria

1. Male or female subjects.
2. Age =18 to = 55 years.
3. All subjects must have a serologically documented HIV diagnosis.
4. Subjects receiving ART according to the national and/or International guidelines and recommendations observed by the trial centers.
5. ART maintained without interruption for at least 3 years prior to randomization.
6. Plasma HIV RNA maintained <20 copies/mm3. Should the subject have a record of a viral blip, the blip should have been documented by record of a negative HIV RNA test before the observed blip and a re-controlled negative HIV RNA after the observed blip.
7. CD4 count =500 cells/mm3 at screening.
8. Documented CD4 nadir of =250 cells/mm3.
9. Capability and availability to comply with trial constraints and requirements; evaluation by the investigators, acceptance and signature of the ICF.
10. If available, preART viral load levels and CD4 levels values must be taken within 6 months of ART initiation.
a. Note: Patient are still eligible if these data are not available.
11. Subjects who have never received Vacc-4x.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 192
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Subjects with contraindications (hypersensitivity included) to Leukine®, see Appendix 1.
2. Subjects with contraindications to the practice of i.d. injections.
3. Subjects who have received a HIV experimental therapeutic or preventive vaccination or immune-modulatory or interleukin-based treatment within 3 years of randomization.
4. Subjects with a history of treatment with chemotherapeutic agents within 2 years of ran-domization.
5. Subjects on a Protease Inhibitor-based regimen during three months preceding randomization.
6. History of any latency activating agent, notably HDACi use within 24 months preceding randomization.
7. Any vaccinations within 4 weeks of randomization, excluding influenza vaccinations.
8. Any acute and clinically significant infection within the last 4 weeks of randomization.
9. Subjects with a history of AIDS defining condition.
10. Clinical abnormalities, as determined by physical examination alone, indicative of chronic active disease states. Subjects with acute or chronic conditions which are either non-stabilized or not in remission as per the investigator's opinion.
11. Subjects with a history of clinically significant cardiac disease, symptomatic or asymptomatic arrhythmias, syncope episodes, or additional risk factors for Torsades de Pointes (e.g. heart failure, congenital long QT syndrome).
12. Subjects receiving concomitant medication according to Appendix 5.
13. Subjects with a history of current or past:
a. HBV infection.
b. HBV/HDV infection.
c. HCV infection.
14. Subjects with recurrent Herpes Zoster.
15. Subjects with recurrent herpes infection (HSV-1 or HSV-2 reactivation) that cannot be controlled with valaciclovir.
16. Subjects with clinically significant laboratory abnormalities:
a. Hemoglobin =12 g/dL
b. Platelet count =150 x109/L
c. Absolute neutrophil count =2.0x109/L
d. Hepatic transaminases (AST or ALT) =1.5 x ULN
e. Serum total bilirubin =1.5 x ULN
f. Specific or standard (CRP and CBC) =1.5 x ULN
g. eGFR =60 mL/min (based on serum creatinine or other appropriate validated markers)
h. Serum potassium, magnesium, phosphorus outside =1.5 x ULN/LLN
17. Subjects with acute or chronic major psychiatric conditions (i.e. schizophrenia, major depression or bipolar disease) which are either non-stabilized or not in remission as per the investigator's clinical assessment, or are in need of continual psycho-active medications.
18. Subjects with a history of multiple sclerosis including subjects in remission.
19. Subjects with a history of substance and/or alcohol abuse/dependency within the last 24 months prior to randomization.
20. Males who are unwilling to use barrier contraception during the entire course of the present trial.
21. ECG at screening that shows QTc >450 msec for males and >470 msec for women when calculated using the Fridericia formula from either lead V3 or V4.
22. Subjects who have switched ART regimens more than once due to

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified