HIV InfectionsPhase 1NCT03753867
RA Effect on Cell Surface Molecules in Vivo
A Phase 1 study testing Acitretin in people with HIV Infections, run by Ottawa Hospital Research Institute.
Trial summary
This study will follow a group of healthy male participants for about 18 weeks to see the effect of taking Acitretin on their immune cells Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- Acitretin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 7 Jan 2019to 8 May 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male gender
- Age 18 - 65
- Able to provide informed consent
- Willingness to participate in study treatment and follow-up
- Willingness for serial phlebotomy and storage and future viro-immunological assays
Who cannot join
- Female gender
- Participants with a known hypersensitivity/allergy to the acitretin.
- Participants who are actively participating in an experimental therapy study or who have received experimental therapy within the last 1 year.
- Participants who are a poor medical risk because of other systemic diseases or active uncontrolled infections including HIV, Hepatitis B or C, and tuberculosis
- Participants with impaired glucose tolerance including prediabetes or diabetes mellitus, dyslipidemia, or liver dysfunction
- Previous or current history of mood disorder, psychosis, or suicidality
- Participants currently receiving ongoing treatment with methotrexate, tetracyclines, or other retinoids
About this study
Official title: Retinoic Acid Effect on Cell Surface Molecules in Vivo
This study will follow a group of healthy male participants for about 18 weeks to see the effect of taking Acitretin on their immune cells
Read the detailed description
Retinoids have been shown in in vitro and ex vivo models to have the ability to reverse latency reactivating the HIV reservoir and the potential for selective eradication of HIV-harbouring cells. We feel that acitretin shows significant potential as a potential adjuvant to current ART regimens, however, there is a lack of data to demonstrate that treatment with acitretin at normal are able to induce molecular and transcription changes consistent with the above activities. In order to provide a scientific basis for retinoid therapy in HIV infection, a Phase I trial of acitretin in human subjects is proposed.
- Conditions
- HIV Infections
- Being tested
- Acitretin
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcitretinDrug
Acitretin will be provided to participants in the formulation Soriatane. Soriatane doses are oral tablets taken daily by the participant. Participants will then receive 35mg of oral acitretin (Soriatane) daily for 8 weeks during the intervention phase. Participants will be asked to return two months after completion of the acitretin course for clinical follow-up and additional phlebotomy for laboratory testing.
| Study group | Role | What they receive |
|---|---|---|
| Acitretin treatment | Experimental | Not described Receives: Drug: Acitretin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Safety of Acitretin use in healthy volunteers will be assessed using safety labs and C-SSRS
Measured: up to 5 months
Secondary outcomes (4)
Change in α4β7 expression on peripherally circulating CD4 T cells
Absolute change in α4β7 expression on peripherally circulating CD4 T cells measured using flow cytometry
Measured: Serial phlebotomy measured over 5 months
Maximum Plasma Concentration [Cmax]
Serum concentrations measured by HPLC
Measured: Trough concentrations measured serially over 2 months of active treatment
Change in RIG-1 expression, p300 expression, mTOR expression
Absolute change in RIG-1 expression by qRTPCR, and change in p300 expression by western blot, change in mTOR expression by qRTPCR and mTOR total/phosphorylated by western blot
Measured: Serial phlebotomy measured over 5 months
Area Under the Curve [AUC]).
Serum concentrations measured by HPLC
Measured: Trough concentrations measured serially over 2 months of active treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2018
- Study start7 Jan 2019 (estimated)
- Primary completion8 May 2019 (estimated)
- Study completion8 May 2019 (estimated)
Why it stopped: The study was withdrawn.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jonathan B Angel, MD, FRCPC, Principal investigator, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03753867
- Sponsor's protocol ID
- 2018 0639
- Status last verified
- Mar 2020
- First submitted
- 1 Oct 2018
- Last updated
- 4 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retinoic Acid Effect on Cell Surface Molecules in Vivo
- ClinicalTrials.gov ID
- NCT03753867
- Acronym / sponsor ID
- 2018 0639
- Conditions
- HIV Infections
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was withdrawn.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- 7 Jan 2019 (estimated)
- Primary completion
- 8 May 2019 (estimated)
- Study completion
- 8 May 2019 (estimated)
- First posted
- 27 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will follow a group of healthy male participants for about 18 weeks to see the effect of taking Acitretin on their immune cells
Detailed description
Retinoids have been shown in in vitro and ex vivo models to have the ability to reverse latency reactivating the HIV reservoir and the potential for selective eradication of HIV-harbouring cells. We feel that acitretin shows significant potential as a potential adjuvant to current ART regimens, however, there is a lack of data to demonstrate that treatment with acitretin at normal are able to induce molecular and transcription changes consistent with the above activities. In order to provide a scientific basis for retinoid therapy in HIV infection, a Phase I trial of acitretin in human subjects is proposed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acitretin treatment | Experimental | Drug: Acitretin |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male gender
- Age 18 - 65
- Able to provide informed consent
- Willingness to participate in study treatment and follow-up
- Willingness for serial phlebotomy and storage and future viro-immunological assays
Key exclusion criteria (7 listed)
- Female gender
- Participants with a known hypersensitivity/allergy to the acitretin.
- Participants who are actively participating in an experimental therapy study or who have received experimental therapy within the last 1 year.
- Participants who are a poor medical risk because of other systemic diseases or active uncontrolled infections including HIV, Hepatitis B or C, and tuberculosis
- Participants with impaired glucose tolerance including prediabetes or diabetes mellitus, dyslipidemia, or liver dysfunction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcitretinAcitretin will be provided to participants in the formulation Soriatane. Soriatane doses are oral tablets taken daily by the participant. Participants will then receive 35mg of oral acitretin (Soriatane) daily for 8 weeks during the intervention phase. Participants will be asked to return two months after completion of the acitretin course for clinical follow-up and additional phlebotomy for laboratory testing. | Drug | Acitretin treatment |
Primary outcome
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: up to 5 months
Safety of Acitretin use in healthy volunteers will be assessed using safety labs and C-SSRS
4 secondary outcomes
Change in α4β7 expression on peripherally circulating CD4 T cells
Time frame: Serial phlebotomy measured over 5 months
Maximum Plasma Concentration [Cmax]
Time frame: Trough concentrations measured serially over 2 months of active treatment
Change in RIG-1 expression, p300 expression, mTOR expression
Time frame: Serial phlebotomy measured over 5 months
Area Under the Curve [AUC]).
Time frame: Trough concentrations measured serially over 2 months of active treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan B Angel, MD, FRCPC principal investigator
Ottawa Hospital Research Institute
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Acitretin in people with HIV Infections, run by Ottawa Hospital Research Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 (time frame: up to 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2020.