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| Tracking Information | |||||||||
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| First Received Date ICMJE | November 2, 1999 | ||||||||
| Last Updated Date | July 30, 2008 | ||||||||
| Start Date ICMJE | September 1997 | ||||||||
| Primary Completion Date | |||||||||
| Current Primary Outcome Measures ICMJE | |||||||||
| Original Primary Outcome Measures ICMJE | |||||||||
| Change History | Complete list of historical versions of study NCT00000917 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Setting up a Blood Bank for Gene Therapy in HIV-Infected Infants | ||||||||
| Official Title ICMJE | Establishment of a Cord Blood Bank for Gene Therapy in HIV-Infected Infants | ||||||||
| Brief Summary | The purpose of this study is to set up a blood bank for infants who have HIV-positive mothers. This blood may be used in the future to treat the child if he/she turns out to be HIV-positive. Blood from the umbilical cord contains a certain kind of cell called a stem cell. Stem cells eventually turn into one of the many types of blood cells. If HIV infection can be prevented in these stem cells, then, when these stem cells are injected back into the infant, the new cells that develop will also be protected from HIV. This study will provide the blood needed to test whether this type of gene therapy is safe and effective. |
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| Detailed Description | Gene therapy may provide a new therapeutic approach to pediatric AIDS. Putting an HIV-resistant gene into umbilical cord blood stem cells and transplanting the cells back into the patient could lead to the production of cells that resist HIV infection. If a patient's cells could be engineered to be resistant to supporting the growth of HIV-1, the cells may have improved survival in the presence of HIV-1. To date, an umbilical cord blood bank for HIV-positive deliveries has not been established in the United States. This protocol establishes a repository of banked umbilical cord blood as a first step toward the potential application of gene therapy for the treatment of HIV-infected infants. HIV-infected mothers have about 20 ml of blood drawn to test for infectious diseases (e.g., hepatitis). At time of delivery maternal HIV viral load is measured. After delivery, about 60 ml of blood is collected from the umbilical cord; this blood is labeled and transferred to the umbilical cord blood bank for possible use in future gene therapy studies on the infant. At birth, infant HIV status and general health are assessed. If the infant is found to be HIV-infected, the mother may be approached about the infant's participation in a future gene therapy study. If the infant is not HIV-infected, the cord blood is stored for up to four years and is then released to the mother, or, with her consent, to the research community. |
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| Study Phase | |||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | |||||||||
| Condition ICMJE |
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| Intervention ICMJE | |||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Terminated | ||||||||
| Enrollment ICMJE | 200 | ||||||||
| Completion Date | |||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria You may be eligible for this study if you:
Exclusion Criteria Your child will not be eligible for this study if he/she:
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| Gender | Both | ||||||||
| Ages | up to 6 Months | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00000917 | ||||||||
| Responsible Party | |||||||||
| Study ID Numbers ICMJE | ACTG 385 | ||||||||
| Study Sponsor ICMJE | National Institute of Allergy and Infectious Diseases (NIAID) | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | National Institute of Allergy and Infectious Diseases (NIAID) | ||||||||
| Verification Date | June 2003 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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