NCT04799483Fut, nem toboroz
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
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2024. márc. 22.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Fut, nem toboroz
- Vizsgálattípus
- Megfigyeléses
- Résztvevők száma
- 32 (tervezett)
- Első benyújtás
- 2021. márc. 15.
- Kezdés
- 2001. jan. 5.
- Elsődleges befejezés
- 2030. jan. 1.
- Fő szponzor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Betegségek
- HIV-fertőzés
- NCT-szám
- NCT04799483
Mit vállalsz
- Vizsgálat típusa: Megfigyeléses
- Tervezett résztvevők: 32
- 2001. jan. 5. és az elsődleges befejezés (2030. jan. 1.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
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Korábbi kezelés
- 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).
Más betegség
- 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).
Egyéb
- Refusal to allow the NIH research team to exchange pertinent medical information with the subjects primary medical care provider.
A regiszterben nem jelölt feltételek
- 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.
Életkor a regiszterben: 21 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Egyesült Államok | Ismeretlen állapot |
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