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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06660498




Registration number
NCT06660498
Ethics application status
Date submitted
7/10/2024
Date registered
28/10/2024

Titles & IDs
Public title
Pomalidomide As an Immune-enhancing Agent for the Control of HIV
Scientific title
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
Secondary ID [1] 0 0
2024-512797-10-00 (EU CT no.)
Universal Trial Number (UTN)
Trial acronym
PEACH
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV-1 Infection 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Pomalidomide 2 mg
Treatment: Drugs - Placebo
Treatment: Drugs - Aspirin 75 mg

Active comparator: Pomalidomide - This arm will receive pomalidomide 2 mg oral capsules

Placebo comparator: Placebo - This arm will receive placebo (oral capsules with no active drug)


Treatment: Drugs: Pomalidomide 2 mg
Participants will receive pomalidomide 2 mg/d concurrently with aspirin 75 mg for three cycles, each consisting of 21 days on and a minimum of 7 days off.

Treatment: Drugs: Placebo
Participants will receive placebo concurrently with aspirin 75 mg for three cycles, each consisting of 21 days on and a minimum of 7 days off.

Treatment: Drugs: Aspirin 75 mg
Auxiliary Medicinal Product
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Efficacy of treatment, measured as the time from ART cessation until meeting ART restart criteria.
Timepoint [1] 0 0
From ATI to the end of treatment at visit 18 or 16 weeks after meeting ART restart criteria
Primary outcome [2] 0 0
Safety of treatment, measured by the number of treatment-emergent adverse events (AEs) of grade 3 or higher that are probably or definitely related to the study treatment.
Timepoint [2] 0 0
From enrollment to the end of treatment at visit 18 or 16 weeks after meeting ART restart criteria
Secondary outcome [1] 0 0
Safety, defined as all other treatment-emerging adverse events (AEs)
Timepoint [1] 0 0
From enrollment to the end of treatment at visit 18 or 16 weeks after meeting ART restart criteria
Secondary outcome [2] 0 0
Rebound viral kinetics during the ATI, including plasma HIV-1 RNA copies/mL doubling times
Timepoint [2] 0 0
From ATI to the end of treatment at visit 18 or 16 weeks after meeting ART restart criteria
Secondary outcome [3] 0 0
The proportion of participants maintaining HIV-1 RNA levels below 1,000 copies/mL at the end of the ATI.
Timepoint [3] 0 0
From ATI to the end of treatment at visit 18 or 16 weeks after meeting ART restart criteria
Secondary outcome [4] 0 0
The proportion of participants who have not met ART restart criteria at the end of the ATI.
Timepoint [4] 0 0
From ATI to the end of treatment at visit 18 or 16 weeks after meeting ART restart criteria
Secondary outcome [5] 0 0
The frequency of peripheral blood CD4+ T cells containing total and intact HIV-DNA while on suppressive ART
Timepoint [5] 0 0
From enrollment to the end of treatment at visit 18 or 16 weeks after meeting ART restart criteria
Secondary outcome [6] 0 0
HIV-specific CD4+ responses
Timepoint [6] 0 0
From enrollment to the end of treatment at visit 18 or 16 weeks after meeting ART restart criteria
Secondary outcome [7] 0 0
HIV-specific CD8+ T cell responses
Timepoint [7] 0 0
From enrollment to the end of treatment at visit 18 or 16 weeks after meeting ART restart criteria
Secondary outcome [8] 0 0
The proportion of cells containing constitutive and inducible MS HIV-RNA
Timepoint [8] 0 0
From enrollment to the end of treatment at visit 18 or 16 weeks after meeting ART restart criteria
Secondary outcome [9] 0 0
The level of CA-US HIV RNA in peripheral blood CD4+ T cells
Timepoint [9] 0 0
From enrollment to the end of treatment at visit 18 or 16 weeks after meeting ART restart criteria
Secondary outcome [10] 0 0
Numbers of B cells, total lymphocytes, CD8+ T cells and CD4+ T cells including memory subsets
Timepoint [10] 0 0
From enrollment to the end of treatment at visit 18 or 16 weeks after meeting ART restart criteria
Secondary outcome [11] 0 0
Proportions of B cells, total lymphocytes, CD8+ T cells and CD4+ T cells including memory subsets
Timepoint [11] 0 0
From enrollment to the end of treatment at visit 18 or 16 weeks after meeting ART restart criteria

Eligibility
Key inclusion criteria
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 (documented on at least 2 occasions within the last 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 and at least two CD4+ T cell counts >350 cells/uL in the 24 months prior to 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.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
20/11/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/03/2026
Actual
Sample size
Target
32
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Melbourne Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
Denmark
State/province [1] 0 0
Aarhus

Funding & Sponsors
Primary sponsor type
Other
Name
University of Aarhus
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Thomas A. Rasmussen, Associate professor, MD, PhD
Address 0 0
University of Aarhus
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Thomas A. Rasmussen, Associate professor, MD, PhD
Address 0 0
Country 0 0
Phone 0 0
459 350 8934
Fax 0 0
Email 0 0
thomrasm@rm.dk
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
The participant data will be shared with collaborative researchers but in an anonymous form that cannot be traced to the individual participant, according to the General Data Protection Regulation (GDPR) of the European Union.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF)
When will data be available (start and end dates)?
September 2024-September 2026
Available to whom?
Since the study was approved in September 2024, there has been open access to the study protocol, the statistical analysis plan, and the informed consent form through the CTIS platform.
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06660498