HIV-1 Infection Clinical Trial
Official title:
Immunotherapy of HIV-infected Patients An Open, Dose-escalating Assessment of Vacc-C5 With Either GM-CSF or Alhydrogel as Adjuvant in HIV-1-infected Subjects on Antiretroviral Therapy (ART)
Verified date | January 2014 |
Source | Bionor Immuno AS |
Contact | n/a |
Is FDA regulated | No |
Health authority | Norway: Norwegian Medicines Agency |
Study type | Interventional |
Background:
Despite the introduction of highly effective antiretroviral therapy (ART) regimes, which
control the HIV infection and results in increases in CD4 cell counts and an undetectable
viral load, many patients suffer from increased morbidity. There is evidence that presence
of antibodies against the C5 region of gp120 strongly correlates with slower disease
progression, and that loss of antibody responses to this region are associated with
progression.
Investigational product:
Vacc-C5 is a single heterodimeric peptide-based HIV therapeutic vaccine corresponding to the
C5 region on gp120 and the external domain of gp41. The vaccine is intended to create a
non-neutralizing antibody against C5 region.
Study objectives:
1. To evaluate safety of the vaccination regimens
2. To evaluate C5-specific humoral immune responses (antibodies), T cell responses, T cell
activation markers and other immune markers.
Status | Completed |
Enrollment | 36 |
Est. completion date | November 2013 |
Est. primary completion date | November 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 55 Years |
Eligibility |
Inclusion Criteria: - Age between18 years and 55 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. Single blips (up to 500 copies/mL) are allowed. - Documented pre-study CD4 cell count = 400x106/L for at least six months (if below at screening, a re-analysis is allowed). - Nadir (lowest ever) CD4 cell count = 200x106/L (nadir below 200x106/L requires two consecutive analyses). - Signed informed consent. Exclusion Criteria: - 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 viral hepatitis B or C or 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 subjects 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. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Norway | Oslo University Hospital, Ullevål | Oslo |
Lead Sponsor | Collaborator |
---|---|
Bionor Immuno AS |
Norway,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety measured as change of AE records, clinical chemistry (incl. CD4, CD8, HIV-1 RNA)and hematology laboratory elevations | AEs recorded at each scheduled and unscheduled visit. Concomitant medications recorded at each scheduled visit. Vital signs (heart rate, blood pressure) at screening, weeks 1, 4, 6, 12, 13, 15, 21, 22 and 26 (End of study). Weight at screening and weight at weeks 1, 12 and 26 (End of study). Clinical laboratory evaluations (clinical chemistry, hematology) at screening, weeks 1, 4, 6, 12, 15, 21 and 26 (End of study). Viral load (HIV-1 RNA) at screening, weeks 1, 6, 15 and 26 (End of study). Urine stix at weeks 1, 4, 6, 12, 15, 21 and 26 (End of study). |
From screening and week 1 to weeks 2, 4, 6, 12, 13, 15, 21, 22 and 26 | Yes |
Secondary | Change in Humoral and T cell responses | Humoral immune response - C5 antibody level at screening, weeks 1, 4, 6, 12, 13, 15, 21, 22 and 26 (End of study). B cell antibody level at weeks 1, 6, 13 and 22. T cell response and activation markers (e.g. CD38, HLA-DR) and other immune markers at weeks 1, 6, 15and 26 (End of study). |
From screening and week 1 to weeks 4, 6, 12, 13, 15, 21, 22 and 26 | No |
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