HIV-1-infectionATINCT06582797
Analytical Treatment Interruption in a Patient With HIV Post Allogeneic Stem Cell Transplantation From a CCR5 delta32 Homozygous Donor
A study testing discontinuation of ART in people with HIV-1-infection, run by University of Kansas Medical Center.
Trial summary
Patients who have Human Immunodeficiency Virus-1 (HIV-1) infection, who also had a stem cell transplant may have achieved cure of their HIV infection. Once the patients blood shows no detectable levels of HIV virus in their blood collected from a process called leukapheresis, they will be closely monitored while… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV-1-infection
- What is being tested?
- discontinuation of ART
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Sep 2024to Sep 2034
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Positive HIV testing
- Has undergone a stem cell transplant
Who cannot join
- under 18 years of age
- unwilling to comply with protocol
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Patients who have Human Immunodeficiency Virus-1 (HIV-1) infection, who also had a stem cell transplant may have achieved cure of their HIV infection. Once the patients blood shows no detectable levels of HIV virus in their blood collected from a process called leukapheresis, they will be closely monitored while discontinuing their HIV treatment which is know as antiretroviral therapy or, ART. They will be tested regularly and monitored for up to 52 weeks at which point they may be considered cured of their HIV.
Read the detailed description
On week -1, a HIV VL and CD4 count will be drawn. If VL remains undetectable, at study week 0, and no other exclusion criteria noted, subject will discontinue ART and enter ATI phase of the study. HIV-1 plasma VL will be monitored every 2 weeks for 52 weeks, then patient returns under the care of their HIV provider. CD4 T cell count will be monitored every 4 weeks.
Depressions symptom check with PHQ-9 check monthly with study visits. Since patients might be cured and at risk of acquiring HIV during the period of treatment interruption, they will be offered Prep on Demand (Truvada) to be used no more than once a month (with notification of study PI when it happens). When Prep on Demand is used, we will ask patient to come in for ART drug level measurement same week.
If patient meets any of the restart ART criteria during the interruption phase, they will discontinue the ATI phase of study and re-start ART and enter the follow up ART phase. If subject maintains undetectable plasma HIV VL (assay quantification threshold 20 copies/mL), they will remain off ART and continue to be monitored until restart criteria are met. If patient meets the restart criteria, they will be followed for 12 months post re-initiation of therapy by their HIV provider. The first month post restart of therapy will require weekly visits, followed by monthly visits thereafter until HIV VL is back <50 copies/mL. Leukapheresis (per previously approved protocol that patient consented to) will be performed at 6 months and 12 months post ATI if in continued viral remission.
- Conditions
- HIV-1-infection
- Being tested
- discontinuation of ART
- Keywords
- stem cell transplant, HIV proof of cure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
discontinuation of ARTOther
patient will discontinue their standard of care HIV treatment with ART while being closely monitored
| Study group | Role | What they receive |
|---|---|---|
| treatment withdraw | Experimental | patient with discontinue standard of care treatment for their HIV infection Receives: Other: discontinuation of ART |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proof of cure
patient will prove cured of HIV infection if no viral load tests result positive over the duration of study
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2024
- Study startSep 2024 (estimated)
- Primary completionSep 2034 (estimated)
- Study completionSep 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-1-infectionStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Wissam El Atrouni, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06582797
- Sponsor's protocol ID
- 160833
- Acronym
- ATI
- Status last verified
- Aug 2024
- First submitted
- 30 Aug 2024
- Last updated
- 3 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analytical Treatment Interruption in a Patient With HIV Post Allogeneic Stem Cell Transplantation From a CCR5 delta32 Homozygous Donor
- ClinicalTrials.gov ID
- NCT06582797
- Acronym / sponsor ID
- ATI / 160833
- Conditions
- HIV-1-infection
- Keywords
- stem cell transplant, HIV proof of cure
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Sep 2024 (estimated)
- Primary completion
- Sep 2034 (estimated)
- Study completion
- Sep 2034 (estimated)
- First posted
- 3 Sep 2024 (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.
Patients who have Human Immunodeficiency Virus-1 (HIV-1) infection, who also had a stem cell transplant may have achieved cure of their HIV infection. Once the patients blood shows no detectable levels of HIV virus in their blood collected from a process called leukapheresis, they will be closely monitored while discontinuing their HIV treatment which is know as antiretroviral therapy or, ART. They will be tested regularly and monitored for up to 52 weeks at which point they may be considered cured of their HIV.
Detailed description
On week -1, a HIV VL and CD4 count will be drawn. If VL remains undetectable, at study week 0, and no other exclusion criteria noted, subject will discontinue ART and enter ATI phase of the study. HIV-1 plasma VL will be monitored every 2 weeks for 52 weeks, then patient returns under the care of their HIV provider. CD4 T cell count will be monitored every 4 weeks.
Depressions symptom check with PHQ-9 check monthly with study visits. Since patients might be cured and at risk of acquiring HIV during the period of treatment interruption, they will be offered Prep on Demand (Truvada) to be used no more than once a month (with notification of study PI when it happens). When Prep on Demand is used, we will ask patient to come in for ART drug level measurement same week.
If patient meets any of the restart ART criteria during the interruption phase, they will discontinue the ATI phase of study and re-start ART and enter the follow up ART phase. If subject maintains undetectable plasma HIV VL (assay quantification threshold 20 copies/mL), they will remain off ART and continue to be monitored until restart criteria are met. If patient meets the restart criteria, they will be followed for 12 months post re-initiation of therapy by their HIV provider. The first month post restart of therapy will require weekly visits, followed by monthly visits thereafter until HIV VL is back <50 copies/mL. Leukapheresis (per previously approved protocol that patient consented to) will be performed at 6 months and 12 months post ATI if in continued viral remission.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment withdraw | Experimental | Other: discontinuation of ARTpatient with discontinue standard of care treatment for their HIV infection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Positive HIV testing
- Has undergone a stem cell transplant
Key exclusion criteria (2 listed)
- under 18 years of age
- unwilling to comply with protocol
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 |
|---|---|---|
| discontinuation of ARTpatient will discontinue their standard of care HIV treatment with ART while being closely monitored | Other | treatment withdraw |
Primary outcome
Proof of cure
Time frame: 52 weeks
patient will prove cured of HIV infection if no viral load tests result positive over the duration of study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2024.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing discontinuation of ART in people with HIV-1-infection, run by University of Kansas Medical Center.
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 2 inclusion and 2 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: opening soon, as of the sponsor's last update on 3 Sep 2024. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Karen M Snyder, BS, CCRC (913-588-8002, ksnyder6@kumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proof of cure (time frame: 52 weeks). 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 3 Sep 2024.