Assessment of VAC-3S Therapeutic Properties When Combined With Standard ART in the Course of HIV-1 Infection

HIV Clinical Trial

Official title:

Assessment of VAC-3S Therapeutic Properties When Combined With Standard Antiretroviral Therapy (ART) in the Course of HIV-1 Infection. A European, Randomized, Double Blind Placebo-controlled Phase II Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02041247
• Other study ID #: IPROTECT1
• Secondary ID: 2013-002735-23
• Status: Active, not recruiting
• Phase: Phase 2
• First received: November 27, 2013
• Last updated: June 16, 2016
• Start date: January 2014
• Est. completion date: November 2016

Study information

• Verified date: June 2016
• Source: InnaVirVax
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Paul-Ehrlich-InstitutSpain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the protective effect of VAC-3S in controlled HIV patients receiving standard of care antiretroviral treatment.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 90
• Est. completion date: November 2016
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

1. Documented HIV-1 infection,

2. Adults > 18 and < 60 years of age,

3. Able and willing to comply with the protocol, including availability for all scheduled study visits,

4. Provided a signed written informed consent,

5. Meets study screening physical, medical history and laboratory assessments (defined below),

6. On stable antiretroviral therapy that is consistent with the current standard of care for at least 12 months prior to study screening,

7. Plasma HIV RNA < 50 cps/mL during the previous 12 months,

8. CD4+ T cell count at screening > 200 and < 500 cells/mm3,

9. Adequate hematology, biochemistry, and metabolic blood tests defined as being less than grade 2 according to the Division of AIDS Adverse Events (See Appendix 23.1), except for the numeration of CD4 and for the numeration of lymphocytes,

10. Adequate hepatic and renal function defined as being less than Grade 2 according to the Division of AIDS Adverse Events (See Appendix 23.1),

11. Female patients of childbearing age with one documented negative blood pregnancy tests between Screening and Visit 1/Month 0; Female patient of childbearing potential must be receiving two forms of effective contraception and must be willing to use them throughout the study duration. These include oral, transdermal, systemic or implant contraception birth control, intra-uterine devices (IUD), abstinence and double barrier method such as diaphragm with spermicidal gel or other recommended double barrier method,

12. Affiliated with the National Medical Insurance System,

13. Believed by investigator to be able and willing to comply with the requirements of the study protocol and will be available for all scheduled visits at the study site.

Exclusion Criteria:

1. Not meeting all of the inclusion criteria listed above,

2. Administration of any investigational drug or device within 28 days prior to screening,

3. Prior history of an AIDS-defining event in the past 5 years,

4. Active co-infection with either Hepatitis C Virus (HCV) or Hepatitis B Virus (HBV) or any other active viral hepatitis co-infection,

5. Any acute or clinically significant infections within the past month,

6. Known allergy or intolerance to components of VAC-3S as documented through medical records or via patient interview,

7. Chronic active liver disease as documented by any of the following laboratory assessments: ultrasound, clinical assessment, liver biopsy or equivalent non-invasive methods,

8. Receipt of any known vaccinations within the past 1 month prior to screening,

9. Receipt of any agent in the past 12 months that exerts a known immunological effect (e.g. includes but not limited to IL-2, IL-7, growth hormone…),

10. Patients with Insulin Dependent Diabetes Mellitus, patients receiving anti-diabetic treatment, anticoagulants (excluding daily "baby-dose" aspirin) or daily NSAIDs within one week of study enrollment,

11. Receipt of any contraindicated medications listed in Appendix 23.2,

12. History of or active auto-immune disease,

13. Acute or chronic psychiatric conditions which in the opinion of the investigator would need continual psychological support and/or medications incompatible with study participation,

14. Patients with contraindications to intramuscular injections including, but not limited to, patients with thrombocytopenia and/or anomalies of the coagulation system,

15. Any uncontrolled chronic or acute condition that in the opinion of the investigator would compromise safety of the patient or the ability to properly administer the study.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV

Intervention

Biological:
• VAC-3S
VAC-3S is administered via intra-muscular route in the arm.

Locations

Country	Name	City	State
France	Hôpital Sud Francilien	Corbeil-Essonne
France	Hôpital de la Croix Rousse	Lyon
France	Hôpital Gui de Chauliac	Montpellier
France	Hôpital Bichat - Claude Bernard	Paris
France	Hôpital Cochin Saint Vincent de Paul	Paris
France	Hôpital Européen Georges Pompidou	Paris
France	Hôpital Pitié Salpêtrière	Paris
France	Hôpital Saint-Antoine	Paris
France	Hôpital Tenon	Paris
Germany	Jürgen Rockstroh	Bonn
Germany	Gerd Fätkenheuer	Köln
Spain	Hospital Clinic University of Barcelona	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
InnaVirVax

Countries where clinical trial is conducted

France,  Germany,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	anti-3S antibodies titer		From D0 to week 24	No
Secondary	tolerance to 6 vaccinations of VAC-3S	safety parameter changes according to the DAIDS (Division of Acquired Immunodeficiency Syndrome) adverse events (AEs) grading table.Safety parameters include adverse events, vital signs, physical examinations, laboratory tests (hematology, blood chemistry, viral load, CD4 and CD8 counts)	From D0 to week 72	No
Secondary	blood inflammatory marker concentrations	Inflammatory markers include: Highly sensitive C-reactive protein (hsCRP), Highly sensitive Recombinant human interleukin 6 (hsIL-6), Soluble CD14 (sCD14), Soluble CD163 (sCD163), D-dimer, Interferon (IFN)-gamma inducible protein 10 (IP-10), Tumor necrosis factor receptor 1 (sTNFR1) and 2 (sTNFR2), Immunoglobulin G (IgG),	From D0 to week 72	No
Secondary	immunogenic characteristics of VAC-3S	anti-3S antibody titers and determination of anti-3S antibody isotypes and avidity	From D0 to week 72	No
Secondary	lymphocyte phenotype markers	Phenotype markers include: Nkp44L expression on the surface of CD4+ T lymphocytes, phenotypic markers of of lymphocyte differentiation and activation	From D0 to week 72	No
Secondary	secondary virological effects	3S gp41 sequences and proviral HIV reservoir	From D0 to week 72	No