Status:
COMPLETED
Intranasal Modified Vacc-4x Gag Peptides With Endocine as Adjuvant
Lead Sponsor:
Oslo University Hospital
Collaborating Sponsors:
Bionor Immuno AS
Eurocine Vaccines AB
Conditions:
HIV Infection
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
Brief Summary
HIV-specific cellular immunity is hampered in most HIV-infected individuals. Therapeutic immunization in HIV aims to strengthen the HIV-specific cellular immunity, usually in the absence of replicatin...
Detailed Description
HIV-specific cellular immunity is hampered in most HIV-infected individuals, partly because the virus infects CD4+ T cells, the key cell subset in all immune responses. CD4 is the primary HIV receptor...
Eligibility Criteria
Inclusion
- Age above 18 years, both genders.
- HIV positive at least one year.
- Clinically stable on ART for the last 6 months (changes in therapy is allowed as long as the viral load is stable).
- Documented viral load (HIV-1 RNA) less than 50 copies/mL for the last six months.
- Documented stable CD4 cell count ≥ 400x106/L.
- Nadir (lowest ever) CD4 cell count ≥ 200x106/L.
- Signed informed consent.
Exclusion
- Reported pre-study AIDS-defining illness within the previous year.
- Malignant disease.
- On chronic treatment with immunosuppressive therapy.
- Unacceptable values of the hematologic and clinical chemistry parameters, as judged by the Principle Investigator (or designee), including creatinine values \>1.5x upper limit of normal (ULN), and AST (SGOT), ALT (SGPT) and alkaline phosphatase values \>2.5x ULN.
- Concurrent chronic active infection such as chronic viral hepatitis B or C or active tuberculosis.
- Pregnant or breastfeeding women.
- Women of childbearing potential not using reliable and adequate contraceptive methods (defined as: use of oral, implanted, injectable, mechanical or barrier products for the prevention of pregnancy; practicing abstinence; sterile) during the study, or sexually active male patients with partners of childbearing potential unwilling to practice effective contraception during the study.
- Current participation in other clinical therapeutic studies.
- Incapability of compliance to the treatment protocol, in the opinion of the Investigator.
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01473810
Start Date
November 1 2011
End Date
March 1 2012
Last Update
June 20 2012
Active Locations (1)
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1
Department of Infectious Diseases, Oslo University Hospital
Oslo, Norway, NO-0450