Assessment of the therapeutic properties of the VAC-3S immunoprotective vaccine when combined with standard therapy in the course of HIV infection.

Phase 1

• Conditions: Chronically infected HIV-1 patients under viral control on Anti-Retroviral therapy; MedDRA version: 14.1Level: LLTClassification code 10068341Term: HIV-1 infectionSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2013-002735-23-ES
• Lead Sponsor: InnaVirVax

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10-08
• Last Update Posted: 27 June 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 90

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 (diaphragm with spermicidal gel or condoms with contraceptive foam),
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.
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 90
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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,
4. Active co-infection with either HCV or 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

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