Allogeneic Hematopoietic Stem Cell Transplantation in HIV-1 Infected Patients

An observational study of HIV-1 Infection, run by Kirby Institute at 1 site in Australia.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

The purpose of this study is to assess the impact of allogeneic hematopoietic stem cell transplantations (HSCT) in HIV infected patients on the persistence of HIV and the HIV immune response. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: HIV-1 Infection
How many people: 5 participants
Where: 1 siteAustralia
Study dates: Sep 2014to Feb 2015
Phase: Observational
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Patients with HIV infection requiring a HSCT

Who may be able to join

HIV-1 infection, requiring allogeneic, haematopoietic SCT as determined by their treating Physician (Haematologist).
Over 18 years of age
Provision of written, informed consent

Who cannot join

In the opinion of the investigator that the patient is not able to provide informed consent
Hb < 9 (g/dL)
CD4+ T cell count <100 (cells/µl)
Serious coagulation abnormalities, platelet count < 50.
Patients currently taking medications that significantly affect the bleeding time (e.g. warfarine, clexane, FXa antagonists)
History of allergy to local anaesthetics
Pregnancy

Trial locations and contacts

1 site in 1 country.

Australia1 site

St Vincent's Hospital
Sydney, New South Wales, 2010

Other trials in Australia

About this study

The purpose of this study is to assess the impact of allogeneic hematopoietic stem cell transplantations (HSCT) in HIV infected patients on the persistence of HIV and the HIV immune response.

Read the detailed description

To assess the impact of HSCT on the immune response to HIV by measuring HIV specific antigens in peripheral blood (via immune assays such as ELISA and Western blot) longitudinally.
To measure the decay of persisting HIV by sequencing and quantitating HIV RNA in plasma, and HIV DNA and RNA in peripheral blood cells including CD4+ T cells and CD4+ T cell subsets, as well as in tissue cells derived from fine needle lymph node aspirates, and/or bone marrow aspirates, and/or rectal tissue.
To determine the presence of the CCR5 delta 32 allele in the patient prior to and following HSCT which will provide information regarding the presence of this gene in the donor cells.
To correlate these findings to the clinical outcome of the individuals enrolled in this study based on their clinical standard of care assessments following HSCT.

Conditions: HIV-1 Infection
Keywords: HIV, Persistence, Reservoirs, Stem Cell Transplant, Functional Cure

What is being measured

The primary outcome is the main question the study is designed to answer.

Reduction in HIV-1 DNA levels in CD4+ T cells measured by real-time PCR
HIV-1 DNA in CD4+ T cells will be measured by real-time PCR and reported as HIV-1 DNA copies in 10e6 CD4+ T cells
Measured: 3 years

Secondary outcomes (1)

Reduction in HIV-1 Antigens and Antibodies measured by ELISA and Western Blot
HIV-1 antigens and antibodies (Ag/Ab) in peripheral blood will be measured by 4th generation chemiluminescence microparticle immunoassay (CMIA) and by Western blot (WB).
Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2014Feb 2015

First posted8 Apr 2016 (estimated)
Study startSep 2014
Primary completionFeb 2015
Study completionFeb 2015

Why it stopped: 5 participants recruited in 7 years (no recruitment since 2015). Due to rare patient population and due to ongoing COVID-19 demands on healthcare systems, it was decided by the Protocol Steering Committee to terminate this study.

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.
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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 5 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02732457
Sponsor's protocol ID: IVPPHSCT01
Acronym: HSCT-HIV
Status last verified: Oct 2021
First submitted: 23 Mar 2016
Last updated: 8 Nov 2021
Results posted: No
Data monitoring committee: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Cohort of Women Living With HIV-1 and Receiving Bictegravir/Emtricitabine/Tenofovir Alafenamide
HIV (Human Immunodeficiency Virus), Pregnancy
RecruitingPhase 4
A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments
HIV-1-infection
RecruitingObservational study
Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Antiretroviral Naive HIV-1 Research Participants
HIV
Active, not recruitingPhase 3
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With Biktarvy
HIV-1-infection
Active, not recruitingPhase 2/3
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen (ARTISTRY-1)
HIV-1-infection

All HIV-1 Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Allogeneic Hematopoietic Stem Cell Transplantation in HIV-1 Infected Patients
ClinicalTrials.gov ID: NCT02732457
Acronym / sponsor ID: HSCT-HIV / IVPPHSCT01
Conditions: HIV-1 Infection
Keywords: HIV, Persistence, Reservoirs, Stem Cell Transplant, Functional Cure
Study type: Observational
Recruitment status: TerminatedReason stopped: 5 participants recruited in 7 years (no recruitment since 2015). Due to rare patient population and due to ongoing COVID-19 demands on healthcare systems, it was decided by the Protocol Steering Committee to terminate this study.
Enrolment: 5 participants (actual)
Lead sponsor: Kirby InstituteOther government
Study start: Sep 2014 (actual)
Primary completion: Feb 2015 (actual)
Study completion: Feb 2015 (actual)
First posted: 8 Apr 2016 (estimated)
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.

The purpose of this study is to assess the impact of allogeneic hematopoietic stem cell transplantations (HSCT) in HIV infected patients on the persistence of HIV and the HIV immune response.

Detailed description

To assess the impact of HSCT on the immune response to HIV by measuring HIV specific antigens in peripheral blood (via immune assays such as ELISA and Western blot) longitudinally.
To measure the decay of persisting HIV by sequencing and quantitating HIV RNA in plasma, and HIV DNA and RNA in peripheral blood cells including CD4+ T cells and CD4+ T cell subsets, as well as in tissue cells derived from fine needle lymph node aspirates, and/or bone marrow aspirates, and/or rectal tissue.
To determine the presence of the CCR5 delta 32 allele in the patient prior to and following HSCT which will provide information regarding the presence of this gene in the donor cells.
To correlate these findings to the clinical outcome of the individuals enrolled in this study based on their clinical standard of care assessments following HSCT.

Study design

Observational model: Cohort
Time perspective: Prospective

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients with HIV infection requiring a HSCT

Key inclusion criteria (3 listed)

HIV-1 infection, requiring allogeneic, haematopoietic SCT as determined by their treating Physician (Haematologist).
Over 18 years of age
Provision of written, informed consent

Key exclusion criteria (7 listed)

In the opinion of the investigator that the patient is not able to provide informed consent
Hb < 9 (g/dL)
CD4+ T cell count <100 (cells/µl)
Serious coagulation abnormalities, platelet count < 50.
Patients currently taking medications that significantly affect the bleeding time (e.g. warfarine, clexane, FXa antagonists)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Reduction in HIV-1 DNA levels in CD4+ T cells measured by real-time PCR
Time frame: 3 years
HIV-1 DNA in CD4+ T cells will be measured by real-time PCR and reported as HIV-1 DNA copies in 10e6 CD4+ T cells

1 secondary outcome

Reduction in HIV-1 Antigens and Antibodies measured by ELISA and Western Blot
Time frame: 3 years

Results and safety

The study was stopped early (reason given: 5 participants recruited in 7 years (no recruitment since 2015). Due to rare patient population and due to ongoing COVID-19 demands on healthcare systems, it was decided by the Protocol Steering Committee to terminate this study.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2021.
Individual participant dataSharing planned: Undecided

Related trials for HIV-1 Infection

RecruitingObservational study
Cohort of Women Living With HIV-1 and Receiving Bictegravir/Emtricitabine/Tenofovir Alafenamide
HIV (Human Immunodeficiency Virus), Pregnancy
RecruitingPhase 4
A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments
HIV-1-infection
RecruitingObservational study
Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Antiretroviral Naive HIV-1 Research Participants
HIV
Active, not recruitingPhase 3
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With Biktarvy
HIV-1-infection
Active, not recruitingPhase 2/3
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen (ARTISTRY-1)
HIV-1-infection

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.

Mark Polizzotto, MD principal investigator

St Vincent's Hospital, Sydney

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of HIV-1 Infection, run by Kirby Institute at 1 site in Australia.

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 3 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: stopped early, as of the sponsor's last update on 8 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

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?

Reduction in HIV-1 DNA levels in CD4+ T cells measured by real-time PCR (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02732457.

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 8 Nov 2021.