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Setting up a Blood Bank for Gene Therapy in HIV-Infected Infants Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on Setting up a Blood Bank for Gene Therapy in HIV-Infected Infants conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Setting up a Blood Bank for Gene Therapy in HIV-Infected Infants Clinical research trials and Setting up a Blood Bank for Gene Therapy in HIV-Infected Infants healthcare trials happen in a lot of of localities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as Setting up a Blood Bank for Gene Therapy in HIV-Infected Infants. Setting up a Blood Bank for Gene Therapy in HIV-Infected Infants Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Setting up a Blood Bank for Gene Therapy in HIV-Infected Infants clinical trial. Human subjects often receive the most effective healthcare possible for their Setting up a Blood Bank for Gene Therapy in HIV-Infected Infants condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "S" Clinical Trials Conditions > Setting up a Blood Bank for Gene Therapy in HIV-Infected Infants  Setting up a Blood Bank for Gene Therapy in HIV-Infected Infants
Setting up a Blood Bank for Gene Therapy in HIV-Infected Infants
For Condition: HIV Infections,Pregnancy
Status: Terminated
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Observational, Natural History
Minimum Age/Maximum Age: /6 Months
Genders: Both
Protocol Entry Criteria: Inclusion Criteria You may be eligible for this study if you: - Are HIV-positive. Exclusion Criteria Your child will not be eligible for this study if he/she: - Is not expected to live more than 6 months. - Weighs less than 3.3 pounds.
Total Enrollment: 200
Location and Contact Information:
Overall Study Official:
SavitaPahwa, Study Chair,
San Francisco Gen Hosp
San Francisco, California, 94110
United States
UCLA Med Ctr / Pediatric
Los Angeles, California, 900951752
United States
Harbor - UCLA Med Ctr / UCLA School of Medicine
Los Angeles, California, 905022004
United States
Cedars Sinai / UCLA Med Ctr
Los Angeles, California, 900481804
United States
Long Beach Memorial (Pediatric)
Long Beach, California, 90801
United States
UCSF / Moffitt Hosp - Pediatric
San Francisco, California, 941430105
United States
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033
United States
UCSD Med Ctr / Pediatrics / Clinical Sciences
La Jolla, California, 920930672
United States
Additional Information:
Study ID Numbers: ACTG 385;
Study Start Date: September 1997
Record last reviewed: June 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000917
Other Pregnancy Studies:
1. A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Orally Administered SP-303 for the Treatment of Diarrhea in Acquired Immunodeficiency Syndrome (AIDS) Patients
2. The Effect of Oral Candidiasis on the Speech Production, Feeding Skills, and Self-Concept of Children and Adolescents with Symptomatic HIV Infection
3. The Effectiveness of Three Anti-HIV Drug Combinations in HIV-Infected Patients Who Have Never Used Anti-HIV Drugs
4. A Study of Fluconazole in the Treatment of Cryptococcal Meningitis in Patients with AIDS
5. An Assessment of the In Vivo Biological Effects of Diethyldithiocarbamate (DTC) in HIV-Infected Patients
Related Studies:
Other Pregnancy Clinical Trials
Other California Clinical Trials
Other San Francisco Clinical Trials
Setting up a Blood Bank for Gene Therapy in HIV-Infected Infants
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