Pomalidomide as an Immune-enhancing Agent for the Control of HIV

Pomalidomide as an Immune-enhancing Agent for the Control of HIV (PEACH): An Investigator-initiated Phase I/IIb Clinical Trial in People Living With HIV on ART and During Analytical Treatment Interruption

This study is designed to evaluate the safety and efficacy of pomalidomide in HIV-1-infected individuals on ART and to determine the impact of pomalidomide on virological control in people living with HIV during an analytical treatment interruption.

Documented HIV-1 infection

• Age 18-70 years, both included.

• Receiving combination ART for at least 1 year and being on the same ART regimen for at least 4 weeks at the screening visit

• HIV-1 plasma RNA <50 copies/mL for >1 year and <20 copies/mL at screening. Episodes of a single HIV plasma RNA >50-500 copies/mL will not exclude participation if the subsequent HIV plasma RNA was <50 copies/mL

• CD4+ T cell count >500 cells/uL at screening

• Ability and willingness to provide informed consent and to continue ART throughout the study phase I and to discontinue ART at the commencement of study phase II.

• All participants must agree not to participate in a conception process (e.g., active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization, egg donation) during the study.

• A female participant, may be eligible to enter and participate in the study if she:

  • Is of non-child-bearing potential defined as either:

    • Age ≥ 50 years and naturally amenorrheic for ≥ 1 year (amenorrhoea following cancer therapy or during breast-feeding does not rule out childbearing potential)
    • Premature ovarian failure confirmed by a specialist gynecologist
    • Previous bilateral salpingo-oophorectomy, or hysterectomy
    • XY genotype, Turner syndrome, uterine agenesis

  • Is of child-bearing potential with a negative pregnancy test at both Screening and Day 0 and agrees to use one of the following methods of contraception to avoid pregnancy:

    • Complete abstinence from penile-vaginal intercourse from 4 weeks prior to administration of investigational medical product (IMP), throughout the study, and for at least 4 weeks after discontinuation of all study medications
    • Any intrauterine device (IUD) with published data showing that the expected failure rate is <1% per year
    • Male partner sterilization confirmed prior to the female subject's entry into the study, and this male is the sole partner for that subject
    • Approved hormonal contraception (Where other medications to be used in the study (e.g., efavirenz and darunavir) are known, or are likely, to significantly interact with systemic contraceptives, resulting in decreased efficacy of the contraceptive, then alternative methods of non-hormonal contraception are recommended)
    • Any other method with published data showing that the expected failure rate is <1% per year
    • Any contraception method must be used consistently, in accordance with the approved product label and for at least 4 weeks after discontinuation of study therapy.

A heterosexually active male participant, may be eligible to enter and participate in the study if he is:

• Willing to complete abstinence from penile-vaginal intercourse from 4 weeks prior to administration of IP, throughout the study, and for at least 4 weeks after discontinuation of all study medications
• willing to use an effective method of contraception (condom) including those who have had vasectomy performed
• agree on the use of an effective method of contraception with an effective failure rate of <1% by his partner (hormonal contraception, intra-uterine device (IUD), or anatomical sterility) from the day prior to the first dose and for at least 4 weeks after discontinuation of study drug.