NCT04799483Active, not recruiting
Safety and Survival of Genetically Modified White Blood Cells in HIV-infected Twins The Gemini Study
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
Source: ClinicalTrials.gov · Last updated 22 Mar 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 32 (estimated)
- First submitted
- 15 Mar 2021
- Start date
- 5 Jan 2001
- Primary completion date
- 1 Jan 2030
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Diseases
- HIV
- NCT number
- NCT04799483
What you commit to
- Study type: Observational
- Planned participants: 32
- From 5 Jan 2001 to the primary completion date, 1 Jan 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 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).
Other illness
- Refusal to follow Clinical Center policy on partner notification (if HIV-positive).
- 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).
Other
- Refusal to allow the NIH research team to exchange pertinent medical information with the subjects primary medical care provider.
Criteria the registry did not label
- INCLUSION CRITERIA:
- 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.
Age in the registry: 21 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Institutes of Health Clinical Center, 9000 Rockville Pike Coordinator of this site? Confirm its status | Bethesda | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.