testing and validation of the procedures for the collection and the transport to the laboratory of the sponsor in the US (VIRxSYS, Gaithersburg, MD) of PBMC's donated via leukapheresis by HIV-1 infected persons in the Netherlands and the…
ID
Source
Brief title
Condition
- Viral infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Number of leukapheresis products successfully collected from the subjects in
the Netherlands and transported to the United States; number of viable CD4+ T
cells per leukapheresis product; for each leukapheresis product, the percentage
of CD4+ T cells successfully transduced; for each leukapheresis product, the
expansion of CD4+ T cells achieved; for each leukapheresis product, the
post-cryopreservation viability of the expanded cells.
Secondary outcome
Any logistical or technical problems identified from the time the harvested
cells leave the body of the donor to the time the primary measures of outcome
are made will be documented.
Background summary
Even is antiretroviral therapy (ART) has improved the treatment of
HIV-1-infection dramatically, the life long therapy and its side effects make
it b=necessary to look for other treatment options. Treatment that protects
CD4+ T cells against infection with HIV-1 might be beneficial. A possibility is
to modify the CD4+ T cells with a viral vector that expresses an anti-sense RNA
directed against HIV-1. It has been shown that these modified CD4+ T cells
inhibit HIV-1 replication effectively. To perform this strategy, enough CD4+ T
cells have to be taken out a patient and have to be transported to the
laboratory in order to transduce them with the vector. The company VIRxSYS, the
sponsor of the study, is capable to perform this procedure. It is important to
examine the feasibility of the leukapheresis procedure (to harvest the CD4+ T
cells), the feasibility of the transport and the effect of the transport of the
cells to the laboratory before applying the whole treatment. In this study, the
participants will undergo a leukapheresis procedure to harvest the cells, after
which the cells will be transported to the laboratory of the sponsor in the
USA.. The (modified) CD4+ T cells will not be shipped back to the study site in
the Netherlands and will not be given back to the participants. The results of
this study will be important to conduct the study in which the treatment with
the modified CD4+ T cells will be applied.
Study objective
testing and validation of the procedures for the collection and the transport
to the laboratory of the sponsor in the US (VIRxSYS, Gaithersburg, MD) of
PBMC's donated via leukapheresis by HIV-1 infected persons in the Netherlands
and the conformation that the laboratory processes for the treatment,
modification, the replication and Cryopreservation of these PBMCs are good
enough for the therapeutic intervention.
Study design
Prospective observational single center study.
Study burden and risks
There are 3 study visits, which take time and effort for the participants. The
leukapheresis (2nd visit) takes 4 hours and, even if it is a standard procedure
that is used very frequently and which is generally very safe, there is a small
risk for the participant of: irritation, swelling or bruising on the site of
insertion, nausea, vomiting, epileptic insults, blood loss, infection, skin
rash, flushing, hives, numbness and tingling, edema, anaphylactic reaction.
Also the blood draws are a small risk: pain, bruising, lightheadedness,
infection.
200 Perry Parkway
MD 20877 Gaithersburg
Verenigde Staten
200 Perry Parkway
MD 20877 Gaithersburg
Verenigde Staten
Listed location countries
Age
Inclusion criteria
- age 18 years or older;
- able and willing to provide informed consent;
- proven HIV-1-infection;
- good general health;
- CD4+ T-cell count 350 cells/mm3 or higher;
- plasma HIV-1 RNA 5000 copies/mL or higher;
- veins suitable for leukapheresis;
- willing to undergo the leukapheresis procedure, which takes up to 4 hours at clinic;
- body weight over 55 kg.
Exclusion criteria
- earlier treatment with antiretroviral therapy more than 7 days;
- any symptoms, now or in the past, of active or unstable cardiovascular disease (unless treating physician approves participation);
- systolic blood pressure below 100 mm Hg, or systolic blood pressure erect more than 20 mm Hg lower than supine;
- symptoms, now or in the past, of a coagulation disorder;
- subject is pregnant or breast-feeding;
- Laboratory tests for hemoglobin, white blood cells, platelets, renal and liver function outside certain limits.
- use of anti-coagulant medication in the two weeks prior to the scheduled leukapheresis, such as Aspirin, dypiridamole, or warfarin;
- any serious illness requiring treatment and/or hospitalization within 30 days prior to study participation
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 | NL15758.018.06 |