Phase II double-blind, randomised, placebo-controlled study the safety and immunogenicity of H1/IC31 (trademarked), in HIV-infected adults without TB
Not Applicable
- Conditions
- HIV/AIDSTuberculosis
- Registration Number
- PACTR201105000289276
- Lead Sponsor
- Statens Serum Institut
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 48
Inclusion Criteria
1. TB negative
2. HIV infected
3. CD4 count greater than 350 cells per ml cubed
Exclusion Criteria
Evidence of or suspected active TB
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the safety of the H1/IC31 (trademarked) TB vaccine in HIV-infected adults;To evaluate the induction of cellular and humoral immunity of the H1/IC31 (trademarked) TB vaccine in HIV-infected adults
- Secondary Outcome Measures
Name Time Method To describe the effect of H1/IC31 (trademarked) TB vaccine in HIV-infected adults on CD4+ lymphocyte counts;To describe the effect of H1/IC31 (trademarked) TB vaccine in HIV-infected adults on HIV viral loads