Immunotherapy With Vacc-C5 With Adjuvant GM-CSF or Alhydrogel in HIV-1-infected Subjects on ART

• Status: Completed
• Trial end date: 2013-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bionor Immuno AS
• Treatments: Aluminum Hydroxide; Molgramostim; Sargramostim

Criteria

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.