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.

Phase 1

• Conditions: HIV-1; MedDRA version: 9.1Level: LLTClassification code 10020161Term: HIV infection

• Registration Number: EUCTR2006-006212-30-GB
• Lead Sponsor: Imperial College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-06-14
• Study Completion: 2011-10-03
• Last Update Posted: 13 October 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

- Documented HIV-1 positive result.
-Stable on HAART.
-Two screening viral load 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.

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

-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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified