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A Randomised, Open labelled, Phase II, Immunogenicity, and Exploratory Efficacy Evaluation of Therapeutic Immunisations +/- IL-2, GM-CSF and Growth Hormone in HIV-1 Infected Subjects Receiving Highly Active Anti-retroviral Therapy (HAART). - Novel Interventions in HIV-1 Infection.

A Randomised, Open labelled, Phase II, Immunogenicity, and Exploratory Efficacy Evaluation of Therapeutic Immunisations +/- IL-2, GM-CSF and Growth Hormone in HIV-1 Infected Subjects Receiving Highly Active Anti-retroviral Therapy (HAART). - Novel Interventions in HIV-1 Infection.

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2006-006212-30-GB
Enrollment
30
Registered
2007-06-14
Start date
2007-08-09
Completion date
Unknown
Last updated
2020-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV-1 MedDRA version: 9.1 Level: LLT Classification code 10020161 Term: HIV infection

Interventions

Trade Name: Saizen Product Name: Saizen Pharmaceutical Form: Powder and solvent for suspension for injection Product Name: IR103 Product Code: IR103 is a combination of Remune and Amplivax Pharmaceut

Sponsors

Imperial College London
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - Documented HIV-1 positive result. - Stable on HAART. - Two screening viral load 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. 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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) within the 6 months preceding baseline. - Receiving immunosuppressive medication (e.g. Steroids)

Design outcomes

Primary

MeasureTime frame
Main Objective: To investigate if immunological benefit can be induced in chronically infected HIV-1 patients by treatment with HAART supplemented with a vaccine and/or cytokines and hormones.;Secondary Objective: Arm 1 will indicate vaccine efficacy in the presence of cytokine/hormone therapy. Comparisons of responses between patients in arm 1with those in arm 2 will elucidate the effects of the addition of cytokine/hormone therapy on prime/boost immunisation with the vaccine. Comparisons of responses in patients in arms 1 and 2 with those in arm 3 will define additive effect of the vaccines above cytokine/hormone therapy alone. ;Primary end point(s): The primary outcome will be changes in defined cellular immune responses from baseline to week 48 and/or differences in cellular immune response between the study groups.—

Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026