Try our beta test site

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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
InnaVirVax
ClinicalTrials.gov Identifier:
NCT02041247
First received: November 27, 2013
Last updated: June 16, 2016
Last verified: June 2016
  Purpose
The purpose of this study is to evaluate the protective effect of VAC-3S in controlled HIV patients receiving standard of care antiretroviral treatment.

Condition Intervention Phase
HIV
Biological: VAC-3S
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by InnaVirVax:

Primary Outcome Measures:
  • anti-3S antibodies titer [ Time Frame: From D0 to week 24 ]

Secondary Outcome Measures:
  • tolerance to 6 vaccinations of VAC-3S [ Time Frame: From D0 to week 72 ]
    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)

  • blood inflammatory marker concentrations [ Time Frame: From D0 to week 72 ]
    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),

  • immunogenic characteristics of VAC-3S [ Time Frame: From D0 to week 72 ]
    anti-3S antibody titers and determination of anti-3S antibody isotypes and avidity

  • lymphocyte phenotype markers [ Time Frame: From D0 to week 72 ]
    Phenotype markers include: Nkp44L expression on the surface of CD4+ T lymphocytes, phenotypic markers of of lymphocyte differentiation and activation

  • secondary virological effects [ Time Frame: From D0 to week 72 ]
    3S gp41 sequences and proviral HIV reservoir


Estimated Enrollment: 90
Study Start Date: January 2014
Estimated Study Completion Date: November 2016
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: VAC-3S 16µg/administration
VAC-3S 16µg/ml administered every 4 weeks for 3 months followed by 3 maintenance vaccinations every 12 weeks after the third initial vaccination.
Biological: VAC-3S
VAC-3S is administered via intra-muscular route in the arm.
Placebo Comparator: VAC-3S Placebo
VAC-3S placebo administered every 4 weeks for 3 months followed by 3 maintenance vaccinations every 12 weeks after the third initial vaccination.
Biological: VAC-3S
VAC-3S is administered via intra-muscular route in the arm.
Active Comparator: VAC-3S 32 µg/administration
VAC-3S 32µg/ml administered every 4 weeks for 3 months followed by 3 maintenance vaccinations every 12 weeks after the third initial vaccination.
Biological: VAC-3S
VAC-3S is administered via intra-muscular route in the arm.
Active Comparator: VAC-3S 64 µg/administration
VAC-3S 64µg/ml administered every 4 weeks for 3 months without maintenance vaccination.
Biological: VAC-3S
VAC-3S is administered via intra-muscular route in the arm.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02041247

Locations
France
Hôpital Sud Francilien
Corbeil-Essonne, France, 91106
Hôpital de la Croix Rousse
Lyon, France, 69317
Hôpital Gui de Chauliac
Montpellier, France, 34295
Hôpital Saint-Antoine
Paris, France, 75012
Hôpital Pitié Salpêtrière
Paris, France, 75013
Hôpital Cochin Saint Vincent de Paul
Paris, France, 75014
Hôpital Européen Georges Pompidou
Paris, France, 75015
Hôpital Bichat - Claude Bernard
Paris, France, 75018
Hôpital Tenon
Paris, France, 75020
Germany
Jürgen Rockstroh
Bonn, Germany, 53105
Gerd Fätkenheuer
Köln, Germany, 63225
Spain
Hospital Clinic University of Barcelona
Barcelona, Spain, 08036
Sponsors and Collaborators
InnaVirVax
Investigators
Study Director: Raphael Ho Tsong Fang, DVM PhD InnaVirVax
  More Information

Responsible Party: InnaVirVax
ClinicalTrials.gov Identifier: NCT02041247     History of Changes
Other Study ID Numbers: IPROTECT1
2013-002735-23 ( EudraCT Number )
Study First Received: November 27, 2013
Last Updated: June 16, 2016

ClinicalTrials.gov processed this record on March 27, 2017