To determine the safety and immunogenicity of gp160 (MicroGeneSys), rgp120/HIV-1MN (Genentech), and rgp120/HIV-1SF2 (BIOCINE) and their adjuvants in HIV-infected children 1 month to 18 years of age. The initiation of this immunotherapy trial will provide multiple benefits by assessing in asymptomatic HIV-infected children a therapy currently being tested in their adult counterparts, in the hope of forestalling the progression of HIV immunosuppression and clinical disease.
The initiation of this immunotherapy trial will provide multiple benefits by assessing in asymptomatic HIV-infected children a therapy currently being tested in their adult counterparts, in the hope of forestalling the progression of HIV immunosuppression and clinical disease. Patients are randomized to receive one of three vaccines (9 patients/vaccine) or the adjuvant placebos (3 patients/vaccine). The vaccines will be studied at both low and high doses. When three of four patients at the low dose of a vaccine have received two immunizations without evidence of dose-limiting toxicity, dose escalation to the higher dose of that vaccine is initiated in subsequent patient cohorts, provided all low dose arms are filled. A total of six immunizations are given, at 0, 4, 8, 12, 16, and 24 weeks. Patients are followed for 24 weeks after the last immunization.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
72
Long Beach Memorial Med. Ctr., Miller Children's Hosp.
Long Beach, California, United States
Childrens Hosp. LA - Dept. of Ped., Div. of Clinical Immunology & Allergy
Los Angeles, California, United States
UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS
Los Angeles, California, United States
Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.
Oakland, California, United States
San Francisco Gen. Hosp.
San Francisco, California, United States
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
UCSF Pediatric AIDS CRS
San Francisco, California, United States
Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases
Torrance, California, United States
Univ. of Connecticut Health Ctr., Dept. of Ped.
Farmington, Connecticut, United States
Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease
New Haven, Connecticut, United States
Cook County Hosp.
Chicago, Illinois, United States
...and 24 more locations