MedTrace Logo

Safety and Survival of Genetically Modified White Blood Cells in HIV-infected Twins The Gemini Study

NCT04799483 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 32

Last updated 2024-03-22

No results posted yet for this study

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 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.

Conditions

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Mary E Wright, M.D. · National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-01-05
Primary Completion
2030-01-01
Completion
2030-01-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04799483 on ClinicalTrials.gov