Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
GlaxoSmithKline
This study will address the respective and combined impact of (i) timing between blood collection and peripheral blood mononuclear cells (PBMC) processing \["time-to-process"\] and (ii) timing of PBMC resting before stimulation \["resting -time"\].
Age
18–55
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
All subjects must satisfy all the following criteria at study entry:
Subjects who the Investigator believes can and will comply with the requirements of the protocol.
Written informed consent obtained from the subject prior to any study procedure.
A male or female between and including 18 and 55 years of age at the time of enrollment.
Confirmed HIV-1 infection.
You may not be if
Viral load level between and including 2,000 and 100,000 copies/mL at screening.
CD4+ T cell count \>500 cells/mm3 at screening.
If the subject is female, she must be of non-childbearing potential, i.e., have a current tubal ligation, hysterectomy, ovariectomy or be post-menopausal. Female subjects of childbearing potential may be enrolled in the study, if the subject:
* has practiced adequate contraception for 30 days prior to vaccination, and
* has a negative pregnancy test at screening, and
* has agreed to continue adequate contraception during the entire study period.
The following criteria should be checked at the time of study entry. If any exclusion criterion applies, the subject must not be included in the study:
Infection with HIV-2. This includes subjects with dual infection with HIV-1/HIV-2.
Planned use of any hematotoxic product during the study period.
Planned use of any investigational or non-registered product during the study period.
Acute or chronic, clinically relevant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination, serology and/or medical history at screening.
Grade 3 or grade 4 laboratory abnormalities, as defined by Division of AIDS (DAIDS) grading table, at screening.
Any condition which, in the opinion of the Investigator, could compromise the subject's adherence to the study protocol.
Planned administration of a vaccine not foreseen by the study protocol during the period starting 30 days before the Sample Collection Visit (Visit 2). Vaccine can be administered as after sampling in Visit 2.
Pregnant or lactating female.
Clareo Health | Study to Optimize the Quality of Samples for Cell-mediated Immunity (CMI) in ART-naïve HIV-1-infected Subjects
