Novel Interventions in HIV-1 Infection

• Status: Terminated
• Trial end date: 2011-10-01
• Target enrollment: 0
• Participant gender: All

Summary

For several years there has been interest in why some people with HIV-1 progress more slowly to disease and have longer survival without Highly Active Antiretroviral Therapy (HAART) than others. The investigators and others have identified a few HIV positive individuals who can control their viral load for many years without HAART, these rare individuals do not lose their HIV-1-specific cellular immune responses, which are very important for controlling viral load. This group is referred to as long-term non-progressors (LTNP). Unlike LTNP the majority of HIV-1 infected individuals are chronic progressors (CP) who do not make effective HIV-1-specific cellular immune responses, even when on HAART. We propose to use a novel DNA vaccine boosted with immune based therapy (cytokines and hormones) to try to regenerate the missing HIV-1-specific cellular immune responses to make chronically infected HIV-1+ persons more like LTNP.

By injecting this novel DNA vaccine and immune based therapy into the people who are already infected with HIV-1, the immune system may be stimulated to mount a greater immune response not only to the vaccines but also to real HIV-1 particles and HIV-1-infected cells.

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

Details

• Lead Sponsor: Imperial College London
• Collaborator: Medical Research Council
• Treatments: Aldesleukin; Hormones; Interleukin-2; Sargramostim; Vaccines

Criteria

Inclusion Criteria:

• Documented HIV-1 positive result.

• Stable on HAART.

• Two screening viral loads of <50 cps/ml on 2 consecutive occasions at least one month apart.

• CD4 T cell count of >400 cells/ul.

• Nadir CD4 T cell count of >200 cells/ul.

• Over 18 years of age.

• Willing and able to provide informed consent.

• Female subjects must not be pregnant or lactating.

• Subjects must be using adequate double barrier method of contraception as appropriate.

Exclusion Criteria:

• Prior therapeutic vaccination.

• Acute illness within 2 weeks of the start of the study.

• Prior immunomodulatory therapy (e.g. IL-2, rhGH, GCSF, GM-CSF, HU)

• Receiving immunosuppressive medication (e.g. Steroids)

• Participation in other vaccine trials currently

• Patients with diabetes mellitus type 2

• Patients with cardiac abnormalities

• Patients with pre-existing autoimmune disease

• Patients with active neoplasia

• Patients with evidence of any progression or recurrence of an underlying intra-cranial lesion