Study to Optimize the Quality of Samples for Cell-mediated Immunity (CMI) in ART-naïve HIV-1-infected Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01610427
First received: May 31, 2012
Last updated: November 21, 2012
Last verified: November 2012

May 31, 2012
November 21, 2012
June 2012
October 2012   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01610427 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Study to Optimize the Quality of Samples for Cell-mediated Immunity (CMI) in ART-naïve HIV-1-infected Subjects
Optimizing the Quality of Samples for CMI in Antiretroviral Therapy (ART)-naïve Human Deficiency Virus Type 1 (HIV-1)-Infected Subjects

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.

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"].

Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
HIV Infection
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)
Experimental: HIV-1 Group
Samples for cell-mediated immunity (CMI) in ART-naïve HIV-1-infected subjects aged 18 to 55 years
Intervention: Procedure: Blood sample collection
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
October 2012
October 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

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.

Exclusion Criteria:

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.
Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT01610427
116329
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP