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

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.