Clinical trial NCT02041247: Assessment of VAC-3S Therapeutic Properties When Combined With Standard ART in the Course of HIV-1 Infection
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: HIV
Lead sponsor: InnaVirVax
Sponsor class: INDUSTRY
First posted: 2014-01-22
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
measure: anti-3S antibodies titer
timeFrame: From D0 to week 24
Secondary outcomes:
measure: tolerance to 6 vaccinations of VAC-3S
timeFrame: From D0 to week 72
measure: blood inflammatory marker concentrations
timeFrame: From D0 to week 72
measure: immunogenic characteristics of VAC-3S
timeFrame: From D0 to week 72
measure: lymphocyte phenotype markers
timeFrame: From D0 to week 72
measure: secondary virological effects
timeFrame: From D0 to week 72
Other outcomes:
Locations:
city: Corbeil-Essonne
country: France
facility: Hôpital Sud Francilien
city: Lyon
country: France
facility: Hôpital de la Croix Rousse
city: Montpellier
country: France
facility: Hôpital Gui de Chauliac
city: Paris
country: France
facility: Hôpital Saint-Antoine
city: Paris
country: France
facility: Hôpital Pitié Salpêtrière
city: Paris
country: France
facility: Hôpital Cochin Saint Vincent de Paul
city: Paris
country: France
facility: Hôpital Européen Georges Pompidou
city: Paris
country: France
facility: Hôpital Bichat - Claude Bernard
city: Paris
country: France
facility: Hôpital Tenon
city: Bonn
country: Germany
facility: Jürgen Rockstroh
city: Köln
country: Germany
facility: Gerd Fätkenheuer
city: Barcelona
country: Spain
facility: Hospital Clinic University of Barcelona
Study officials:
affiliation: InnaVirVax
name: Raphael Ho Tsong Fang, DVM PhD
role: STUDY_DIRECTOR
References: