HIV-1 infection HIV-seropositivity
Conditions
Interventions
None listed
Sponsors
VIRxSYS
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Netherlands
Outcome results
None listed