Last updated: 07/17/2024 16:46:01
Study to optimize the quality of samples for cell-mediated immunity (CMI) in ART-naïve HIV-1-infected subjects
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Optimizing the quality of samples used for the evaluation of cell-mediated immune (CMI) responses in antiretroviral therapy (ART)-naïve Human deficiency virus type 1 (HIV-1)-infected subjects
Trial description: 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.
Primary purpose:
Basic Science
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:
Lymphocytes Viability prediction (LOGIT transformed) in CMI samples post-overnight incubation time before intracellular cytokine staining (ICS): “intercept” parameter estimate of the prediction model - condition “none” resting time not included
Timeframe: At Day 15 (sample collection visit)
Lymphocytes Viability prediction (LOGIT transformed estimate) in CMI samples post-overnight incubation time before ICS: time to process and resting time parameter estimates of the prediction model - condition “none” resting time not included
Timeframe: At Day 15 (sample collection visit)
Lymphocytes Viability prediction (LOGIT transformed estimate) in CMI samples post-overnight incubation time before ICS: TP*RT, TP*TP and RT*RT parameter estimates of the prediction model - condition “none” resting time not included
Timeframe: At Day 15 (sample collection visit)
Lymphocytes Viability prediction (LOGIT transformed estimate) in CMI samples post-overnight incubation time before ICS: optimum mean cell viability estimate by the prediction model - condition “none” resting time not included
Timeframe: At Day 15 (sample collection visit)
Lymphocytes Viability prediction (non-transformed estimate) in CMI samples post-overnight incubation time before ICS: “intercept” parameter estimate of the prediction model - condition “none” resting time included
Timeframe: At Day 15 (sample collection visit)
Lymphocytes Viability prediction (non-transformed estimate) in CMI samples post-overnight incubation time before ICS: time to process and resting time parameter estimates of the prediction model - condition “none” resting time included
Timeframe: At Day 15 (sample collection visit)
Lymphocytes Viability prediction (non-transformed estimate) in CMI samples post-overnight incubation time before ICS: TP*RT and RT*RT parameter estimates of the prediction model - condition “none” resting time included
Timeframe: At Day 15 (sample collection visit)
Lymphocytes Viability prediction (non-transformed estimate) in CMI samples post-overnight incubation time before ICS: optimum mean cell viability estimates by the prediction model -condition “none” resting time included.
Timeframe: At Day 15 (sample collection visit)
Secondary outcomes:
Percentage of viable lymphocytes in the CMI samples, post-overnight incubation (classic) before ICS and post-6 hour incubation before ICS
Timeframe: A Day 15 (sample collection visit)
Magnitude of HIV-1 RT specific cluster of differentiation 40 ligand (CD40L+) CD4+ T cell responses in the CMI samples post-overnight ICS/post 6 hour ICS, expressing at least one cytokine
Timeframe: At Day 15 (sample collection visit)
Magnitude of HIV-RT specific (background reduced) CD8+ T cell responses in the CMI samples post-overnight ICS/post 6 hour ICS, expressing at least one cytokine
Timeframe: At Day 15 (sample collection visit)
Number of subjects with serious adverse events (SAEs)
Timeframe: During the whole study period (From Day 0 to Day 15)
Interventions:
Enrollment:
22
Primary completion date:
2012-30-10
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
AIDS
Product
SB732462
Collaborators
Not applicable
Study date(s)
June 2012 to October 2012
Type
Interventional
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18 - 55 years
Accepts healthy volunteers
No
- 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.
- 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.
Inclusion and exclusion criteria
Inclusion criteria:
- 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.
All subjects must satisfy all the following criteria at study entry:
Exclusion criteria:
- 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.
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:
Trial location(s)
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2012-30-10
Actual study completion date
2012-30-10
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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