VAC-3S study in patients infected by HIV and controlled with an antiretroviral treatment who rose their immune response in study study IVVAC-3S/P1

• Conditions: Chronically infected HIV-1 patients under viral control on Anti-Retroviral therapy.; MedDRA version: 18.0Level: LLTClassification code 10068341Term: HIV-1 infectionSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2014-005093-11-FR
• Lead Sponsor: InnaVirVax

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06-23
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- HIV-1 infected patient
- Age between 18 and 60 years
- ART (AntiRetroviral Therapy) initiation ? 1 year ago
- Plasma HIV RNA < 100 copies/ml in the past 12 months
- CD4+ T cell count = 200 cells/mm3,
- Nadir CD4+ T cell count = 100 cells/mm3,
- Female patient of childbearing potential with a negative urine pregnancy test (UPT). Females of non-childbearing potential, i.e., post-menopausal (absence of menstrual bleeding for 1 year, or 6 months with laboratory confirmation of hormonal status), hysterectomy or bilateral oophorectomy, are not required a UPT,
- Female patient of childbearing potential under highly effective contraception defined as two of the following methods of contraception and willing to have two of them for the entire study duration: masculine or feminine condom use, bilateral tubal ligation, intra-uterine device (IUD), oral, transdermal, systemic or implant contraception on a stable dose for at least 3 months,
- A total anti-3S titer = 20 A.U. at any time point of IVVAC-3S/P1 clinical trial.
- Per protocol subject having completed the IVVAC-3S/P1 study.
- Patient affiliated to a social security system,
- Patient who has understood the protocol design and provided a signed written informed consent form,
- Patient who is willing and capable of cooperating to the extent and degree required by the protocol,
- Patient whom the investigator believes he/she can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits) and he/she will be available for all scheduled visits at the investigational 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 15
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Chronic active liver disease,
2. History of HCV co-infection or ongoing replicating HCV (positive RT-PCR) or HBV (positive HbS Ag) coinfection,
3. Any immunotherapy (e.g. IL-2, IL-7, growth hormone…) in the past year at the exception of VAC-3S,
4. Any immunosuppressive therapy (glucocorticoids, cyclosporine, methotrexate) or chronic non-steroidal anti-inflammatory treatment in the past month,
5. Ongoing pregnancy,
6. Breastfeeding women,
7. Patient with known sensitivities to investigational drug (see please the CIB),
8. History of allergy to any vaccine,
9. Any severe chronic condition that would interfere with the study,
10. History of auto-immune disease,
11. Organ transplant,
12. Splenectomy,
13. Psychiatric disorder significant enough to hinder participation as assessed by the investigator,
14. Patient who has participated in a clinical research trial in the 30 days preceding the screening visit (V-1M-1).
15. Patients with contraindications to intramuscular injections including, but not limited to, patients with thrombocytopenia and/or anomalies of the coagulation system,
16. Any uncontrolled chronic or acute condition that in the opinion of the investigator would compromise the 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