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
  Purpose

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.


Condition Intervention Phase
HIV Infection
Procedure: Blood sample collection
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Optimizing the Quality of Samples for CMI in Antiretroviral Therapy (ART)-naïve Human Deficiency Virus Type 1 (HIV-1)-Infected Subjects

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

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 ]

Enrollment: 22
Study Start Date: June 2012
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

Detailed Description:

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"].

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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

Locations
Belgium
GSK Investigational Site
Gent, Belgium, 9000
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01610427     History of Changes
Other Study ID Numbers: 116329
Study First Received: May 31, 2012
Last Updated: November 21, 2012
Health Authority: Belgium: Ministry of Health

Keywords provided by GlaxoSmithKline:
CMI
Antiretroviral therapy-naïve
HIV

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on July 26, 2014