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

GlaxoSmithKline (GSK)

Status: Completed

Conditions: AIDS; AIDS Vaccines

Treatments: Procedure: Blood sample collection

Study type: Interventional

Funder types: Industry

Identifiers

NCT01610427

116329

Details and patient eligibility

About

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.

Full 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"].

Enrollment: 22 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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22 participants in 1 patient group

HIV-1 Group

Experimental group

Description:

Antiretroviral Therapy-naïve HIV1-infected subjects, aged 18 to 55 years, from whom samples for cell-mediated immunity (CMI) were collected. No investigational vaccine was administered.

Treatment:

Procedure: Blood sample collection