HIVNCT04799483
Safety and Survival of Genetically Modified White Blood Cells in HIV-infected Twins The Gemini Study
An observational study of HIV, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
This study will consolidate under one umbrella protocol all NIH studies of the safety and survival of gene-modified lymphocytes in HIV-infected twins. The major purposes of the current study are to: place subjects from the various identical twin cell transfer/gene therapy studies on a single, more uniform schedule of… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- HIV
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jan 2001to 30 Jan 2030
- Phase
- Observational
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who participated in the long-term follow-up phase of previous NIAID/NHGRI intramural research protocols in which unmodified cells, gene marked cells or cells with therapeutic genes were infused.
Who may be able to join
- Activet participation, in an NIAID/CCMD/NHGRI protocol involving the transfer of unmodified lymphocytes, gene-marked lymphocytes or cells containing potentially therapeutic genes in the treatment of HIV-1 infection (cell donors and recipients were eligible).
- Ongoing follow-up with a primary medical care provider who manages the subject's HIV-related and/or other medical conditions.
- Agree to comply with study requirements and clinical policies.
- Able to provide informed consent.
Who cannot join
- A history of gross noncompliance with prior NIAID/CCMD protocol requirements that, in the opinion of the Principal Investigator, is likely to seriously compromise the safety or value of an individual's participation in the present protocol.
- Refusal to follow Clinical Center policy on partner notification (if HIV-positive).
- Refusal to permit research blood specimens to be stored (frozen) for potential future studies, including RCR testing will be excluded (participants who have received gene-modified cells may refuse to have specimens stored for research purposes other than RCR).
- Any medical condition that, in the opinion of the Principal Investigator, would make the subject inappropriate for protocol participation (such as anemia or inadequate venous access).
- Refusal to allow the NIH research team to exchange pertinent medical information with the subjects primary medical care provider.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: The Gemini Study: Study of the Long-Term Safety and Persistence of Cells Following Cell Transfers or Gene Therapy in Identical Twins Discordant for HIV Infection
This study will consolidate under one umbrella protocol all NIH studies of the safety and survival of gene-modified lymphocytes in HIV-infected twins. The major purposes of the current study are to:
- place subjects from the various identical twin cell transfer/gene therapy studies on a single, more uniform schedule of visits;
- examine the long-term safety of apheresis procedures in non-HIV-infected lymphocyte donor twins;
- examine the long-term safety of lymphocytes in HIV-infected lymphocyte recipient twins.
Read more
Identical twins enrolled in NIH protocols 93-I-0110, 94-I-0206, 96-HG-0051, and 97-I-0165 involving the transfer of lymphocytes for the treatment of HIV infection are eligible to continue their research participation under the current protocol, 02-I-0080.
Participants will not undergo any additional research procedures in this study. They will continue to take their antiretroviral therapy and will be followed at least once a year, or more often if medically indicated, with a medical history, physical examination and blood tests for routine studies and to determine the number of lymphocytes in the blood. Recipient twins will also have blood levels of gene-modified lymphocytes checked.
Recipient twins will have some blood stored for RCR (replication competent retrovirus) testing, should it become necessary. A special virus was used to insert genes into the donated lymphocytes and, although the virus was rendered incapable of growing in the body, a theoretical risk exists that the virus could mix with other viruses and possibly begin growing or reproducing. If a participant subsequently develops medical problems, the stored blood samples can be checked for RCR to see if it may be a cause of the problem.
Read the detailed description
Intramural NIAID sponsored several phase I-II studies of cell transfers during the 1990's, including gene-modified cells, in identical twins discordant for HIV infection. These studies were both novel in the field of alternative treatment strategies for HIV infection and served as early studies in the developing field of clinical gene therapy. The current protocol represents an umbrella protocol in which these early trials have been consolidated for purposes of long-term safety monitoring and long-term follow-up of gene-modified cell persistence. Cell recipients as well as donors enrolled in Intramural NIAID twin gene marking, gene therapy and cell transfer studies have been eligible for study participation. Participants are monitored for safety per a uniform standardized schedule. No gene therapy, cell transfers or other investigational therapeutic interventions occur under the auspices of this protocol.
- Conditions
- HIV
- Keywords
- Gene Therapy, HIV, Immunotherapy, Syngeneic Cells, Gemini Study
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the Long-term safety of gene-modified and unmodified infusion
Measured: Annually
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2021
- Study start5 Jan 2001
- Primary completion1 Jan 2030 (estimated)
- Study completion30 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Mary E Wright, M.D., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04799483
- Sponsor's protocol ID
- 020080
- Other IDs
- 02-I-0080
- Status last verified
- Mar 2024
- First submitted
- 15 Mar 2021
- Last updated
- 22 Mar 2024
- Results posted
- No
Publications
Donahue RE, Kessler SW, Bodine D, McDonagh K, Dunbar C, Goodman S, Agricola B, Byrne E, Raffeld M, Moen R, et al. Helper virus induced T cell lymphoma in nonhuman primates after retroviral mediated gene transfer. J Exp Med. 1992 Oct 1;176(4):1125-35. doi: 10.1084/jem.176.4.1125.
PubMed 1383375Carr A, Cooper DA. Adverse effects of antiretroviral therapy. Lancet. 2000 Oct 21;356(9239):1423-30. doi: 10.1016/S0140-6736(00)02854-3.
PubMed 11052597Morgan RA. Genetic strategies to inhibit HIV. Mol Med Today. 1999 Oct;5(10):454-8. doi: 10.1016/s1357-4310(99)01542-7.
PubMed 10498914
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Gemini Study: Study of the Long-Term Safety and Persistence of Cells Following Cell Transfers or Gene Therapy in Identical Twins Discordant for HIV Infection
- ClinicalTrials.gov ID
- NCT04799483
- Acronym / sponsor ID
- 020080
- Conditions
- HIV
- Keywords
- Gene Therapy, HIV, Immunotherapy, Syngeneic Cells, Gemini Study
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 5 Jan 2001 (actual)
- Primary completion
- 1 Jan 2030 (estimated)
- Study completion
- 30 Jan 2030 (estimated)
- First posted
- 16 Mar 2021 (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 consolidate under one umbrella protocol all NIH studies of the safety and survival of gene-modified lymphocytes in HIV-infected twins. The major purposes of the current study are to:
- place subjects from the various identical twin cell transfer/gene therapy studies on a single, more uniform schedule of visits;
- examine the long-term safety of apheresis procedures in non-HIV-infected lymphocyte donor twins;
- examine the long-term safety of lymphocytes in HIV-infected lymphocyte recipient twins.
Identical twins enrolled in NIH protocols 93-I-0110, 94-I-0206, 96-HG-0051, and 97-I-0165 involving the transfer of lymphocytes for the treatment of HIV infection are eligible to continue their research participation under the current protocol, 02-I-0080.
Participants will not undergo any additional research procedures in this study. They will continue to take their antiretroviral therapy and will be followed at least once a year, or more often if medically indicated, with a medical history, physical examination and blood tests for routine studies and to determine the number of lymphocytes in the blood. Recipient twins will also have blood levels of gene-modified lymphocytes checked.
Recipient twins will have some blood stored for RCR (replication competent retrovirus) testing, should it become necessary. A special virus was used to insert genes into the donated lymphocytes and, although the virus was rendered incapable of growing in the body, a theoretical risk exists that the virus could mix with other viruses and possibly begin growing or reproducing. If a participant subsequently develops medical problems, the stored blood samples can be checked for RCR to see if it may be a cause of the problem.
Detailed description
Intramural NIAID sponsored several phase I-II studies of cell transfers during the 1990's, including gene-modified cells, in identical twins discordant for HIV infection. These studies were both novel in the field of alternative treatment strategies for HIV infection and served as early studies in the developing field of clinical gene therapy. The current protocol represents an umbrella protocol in which these early trials have been consolidated for purposes of long-term safety monitoring and long-term follow-up of gene-modified cell persistence. Cell recipients as well as donors enrolled in Intramural NIAID twin gene marking, gene therapy and cell transfer studies have been eligible for study participation. Participants are monitored for safety per a uniform standardized schedule. No gene therapy, cell transfers or other investigational therapeutic interventions occur under the auspices of this protocol.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who participated in the long-term follow-up phase of previous NIAID/NHGRI intramural research protocols in which unmodified cells, gene marked cells or cells with therapeutic genes were infused.
Key inclusion criteria (4 listed)
- Activet participation, in an NIAID/CCMD/NHGRI protocol involving the transfer of unmodified lymphocytes, gene-marked lymphocytes or cells containing potentially therapeutic genes in the treatment of HIV-1 infection (cell donors and recipients were eligible).
- Ongoing follow-up with a primary medical care provider who manages the subject's HIV-related and/or other medical conditions.
- Agree to comply with study requirements and clinical policies.
- Able to provide informed consent.
Key exclusion criteria (5 listed)
- A history of gross noncompliance with prior NIAID/CCMD protocol requirements that, in the opinion of the Principal Investigator, is likely to seriously compromise the safety or value of an individual's participation in the present protocol.
- Refusal to follow Clinical Center policy on partner notification (if HIV-positive).
- Refusal to permit research blood specimens to be stored (frozen) for potential future studies, including RCR testing will be excluded (participants who have received gene-modified cells may refuse to have specimens stored for research purposes other than RCR).
- Any medical condition that, in the opinion of the Principal Investigator, would make the subject inappropriate for protocol participation (such as anemia or inadequate venous access).
- Refusal to allow the NIH research team to exchange pertinent medical information with the subjects primary medical care provider.
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
Evaluate the Long-term safety of gene-modified and unmodified infusion
Time frame: Annually
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 22 Mar 2024.
- Background: PubMed 1383375Donahue RE, Kessler SW, Bodine D, McDonagh K, Dunbar C, Goodman S, Agricola B, Byrne E, Raffeld M, Moen R, et al. Helper virus induced T cell lymphoma in nonhuman primates after retroviral mediated gene transfer. J Exp Med. 1992 Oct 1;176(4):1125-35. doi: 10.1084/jem.176.4.1125.
- Background: PubMed 11052597Carr A, Cooper DA. Adverse effects of antiretroviral therapy. Lancet. 2000 Oct 21;356(9239):1423-30. doi: 10.1016/S0140-6736(00)02854-3.
- Background: PubMed 10498914Morgan RA. Genetic strategies to inhibit HIV. Mol Med Today. 1999 Oct;5(10):454-8. doi: 10.1016/s1357-4310(99)01542-7.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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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.
Mary E Wright, M.D. principal investigator
National Institute of Allergy and Infectious Diseases (NIAID)
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, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
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 4 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 22 Mar 2024. 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 United States. 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?
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?
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?
Evaluate the Long-term safety of gene-modified and unmodified infusion (time frame: Annually). 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 NCT04799483, which also lists 3 linked publications.
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 22 Mar 2024.