Study to Optimize the Quality of Samples for Cell-mediated Immunity (CMI) in ART-naïve HIV-1-infected Subjects
This study has been completed.
Information provided by (Responsible Party):
First received: May 31, 2012
Last updated: October 9, 2014
Last verified: October 2014
The purpose of this study is to investigate a combined set of parameters deemed to impact the quality of CMI analyses in terms of the proportion of viable lymphocytes in antiretroviral therapy-naïve HIV-1 infected subjects.
Procedure: Blood sample collection
||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
||Optimizing the Quality of Samples for CMI in Antiretroviral Therapy (ART)-naïve Human Deficiency Virus Type 1 (HIV-1)-Infected Subjects
Primary Outcome Measures:
- Number of viable lymphocytes in the CMI samples post-overnight intracellular cytokine staining (ICS) for each combination of "time-to-process" (2h, 7h, 24h) and "resting time" (2h, 6h, 18h) [ Time Frame: Sample Collection Visit (Visit 2, Day 15) ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Number of viable lymphocytes in the CMI samples post-overnight ICS for each combination of "time-to-process" (2h, 7h, 24h), and "resting time" of 0h [ Time Frame: Sample Collection Visit (Visit 2, Day 15) ] [ Designated as safety issue: No ]
- Magnitude of HIV-1 specific CD40L+ CD4+ and/or CD8+ T cell responses in the CMI samples post-overnight ICS expressing at least one cytokine after stimulation for each combination of "time-to-process" (2h, 7h, 24h) and "resting time" (0h, 2h, 6h, 18h) [ Time Frame: Sample Collection Visit (Visit 2, Day 15) ] [ Designated as safety issue: No ]
- Number of viable lymphocytes in the CMI samples post-6 hour- ICS for "time-to-process" of 7h and "resting time" of 18h [ Time Frame: Sample Collection Visit (Visit 2, Day 15) ] [ Designated as safety issue: No ]
- Magnitude of HIV-1 specific CD40L+ CD4+ and/or CD8+ T cell responses in the CMI samples post-6 hour-ICS expressing at least one cytokine after stimulation for "time-to-process" of 7h and "resting time" of 18h [ Time Frame: Sample Collection Visit (Visit 2, Day 15) ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||October 2012 (Final data collection date for primary outcome measure)
Experimental: HIV-1 Group
Samples for cell-mediated immunity (CMI) in ART-naïve HIV-1-infected subjects aged 18 to 55 years
Procedure: Blood sample collection
Blood samples will be collected in all subjects at two time points, at the Screening Visit (Day 0) and at the Sample Collection Visit (Day 15)
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"].
|Ages Eligible for Study:
||18 Years to 55 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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.
- ART-naïve and not eligible for ART treatment as per established guidelines. Subjects must never have received ART after HIV diagnosis, including lamivudine used for chronic hepatitis B infection. The exception to this is short-term ART for prevention of mother-to-child transmission (PMTCT) which must have been completed at least 360 days prior to enrollment.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01610427
|GSK Investigational Site
|Gent, Belgium, 9000 |
||GSK Clinical Trials
No publications provided by GlaxoSmithKline
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Bourguignon P, Clément F, Renaud F, Le Bras V, Koutsoukos M, Burny W, Moris P, Lorin C, Collard A, Leroux-Roels G, Roman F, Janssens M, Vandekerckhove L. Processing of blood samples influences PBMC viability and outcome of cell-mediated immune responses in antiretroviral therapy-naïve HIV-1-infected patients. J Immunol Methods. 2014 Dec 1;414:1-10. doi: 10.1016/j.jim.2014.09.001. Epub 2014 Sep 16.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||May 31, 2012
||October 9, 2014
||Belgium: Ministry of Health
Keywords provided by GlaxoSmithKline:
ClinicalTrials.gov processed this record on March 26, 2015