Status:
WITHDRAWN
Safety and Tolerability of a Therapeutic DNA Dendritic Cell Vaccine in HIV-Infected Children, Adolescents, and Young Adults
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
Conditions:
HIV Infections
Eligibility:
All Genders
6-23 years
Phase:
PHASE1
PHASE2
Brief Summary
The therapeutic DNA vaccine, DermaVir, represents an immunization strategy that targets lymph node dendritic cells. Because of the high percentage of naive CD4 cells in children and adolescents, the p...
Detailed Description
The introduction of highly active antiretroviral therapy (HAART) for children and adolescents has resulted in improved control of viral replication for prolonged periods of time and a significant redu...
Eligibility Criteria
Inclusion
- HIV infected
- Receiving HAART consisting of drugs from at least 2 different classes for at least 12 months prior to study entry
- CD4 count of 350 cells/mm3 or greater
- Viral load less than 400 copies/ml for at least 12 months prior to screening
- If female, agree to avoid pregnancy and use two methods of contraception. More information on this criterion can be found in the protocol.
- If male, agree to avoid attempting to impregnate a female and not participate in sperm donation programs. Male participants must agree to use a condom during sexual activity from the date of receipt of the first study vaccination until 6 months after receipt of the last study vaccination.
Exclusion
- Failing antiretroviral regimen
- Skin diseases, including active atopic dermatitis, active or history of psoriasis, active urticaria, known hypersensitivity to adhesive tape, history of keloid, and active or history of vitiligo
- Tattoos or changes in pigment at selected skin vaccination sites
- Hair or tattoo removal in close proximity to vaccine site on skin
- Acute or chronic illness. More information on this criterion can be found in the protocol.
- Chronic autoimmune disease, clinically significant bleeding disorder, or insulin dependent diabetes mellitus
- Clinical toxicity (Grade 2 or greater) at screening
- Prior treatment with any HIV vaccine
- Treatment with any HIV immune modulating agents or chemotherapy for malignancy within 12 months of study entry
- Vaccinations within 28 days of study entry
- Participation in an investigational new drug protocol within 60 days prior to screening
- Systemic steroid therapy within 28 days of study entry
- Abnormal laboratory values. More information on this criterion can be found in the protocol.
- Excessive exposure to the sun
- Breastfeeding or pregnant
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00614640
Last Update
November 1 2021
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