To gain insight in clinical, virological and immunological mechanisms and predictors of the eradication of HIV. To gain insight in the dynamics of the T cell HIV reservoir in which HIV is persisting. To gain insight in different levels of immune…
ID
Source
Brief title
Condition
- Leukaemias
- Immunodeficiency syndromes
- Viral infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Description of clinical, virological and immunological data before and after
transplantation. Assessment of HIV integration sites to determine whether
residual HIV derives from a long lived latent infected cell or from cell
proliferation. Assessment of TRECs to distinguish between recent thymic
emigrant and the peripheral T cell pool.
Secondary outcome
Assessment of different levels of immune responses
Background summary
The implementation of combination antiretroviral therapy (cART) has
substantially reduced AIDS-related morbidity and mortality. cART is unable to
eliminate HIV due to viral persistence of HIV in latent reservoirs and
therefore patients require life-long daily therapy. Current research is
directed at innovative approaches beyond cART towards eradication of the latent
HIV reservoir and cure of infection. The only medical intervention that has
successfully been able to cure HIV was in the Berlin patient by an allogeneic
hematopoietic stem cell transplantation (alloHSCT) with a donor who carried a
HIV-resistance gene (defect in the CCR5 co-receptor of HIV). Since this
success, HIV infected patients requiring a HSCT are of particular interest for
the research community.
Study objective
To gain insight in clinical, virological and immunological mechanisms and
predictors of the eradication of HIV. To gain insight in the dynamics of the T
cell HIV reservoir in which HIV is persisting. To gain insight in different
levels of immune responses before and after HSCT.
Study design
Observational case study of two years.
Study burden and risks
The benefits are a direct and valuable contribution to the knowledge regarding
HIV persistence and cure. Additionally, all finding that could support clinical
decision making will be reported to treating physicians. Risks and burden are
minor since all blood draws are combined with blood sampling for clinical
indications.
Heidelberglaan 100
Utrecht 3508 GA
NL
Heidelberglaan 100
Utrecht 3508 GA
NL
Listed location countries
Age
Inclusion criteria
Stemcel transplantation on clinical indication
HIV infected
18 years old
Exclusion criteria
Any patient unable to give informed consent.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL53114.041.15 |