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Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) Genentech Protein Sciences Corporation |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000762 |
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.
Condition | Intervention | Phase |
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HIV Infections |
Biological: rgp120/HIV-1MN Biological: rgp120/HIV-1 SF-2 Biological: gp160 Vaccine (MicroGeneSys) |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Double-Blind, Safety Study |
Official Title: | A Placebo-Controlled, Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant Envelope Proteins of HIV-1 gp160 and gp120 in Children >= 1 Month Old With Asymptomatic HIV Infection |
Estimated Enrollment: | 72 |
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.
Ages Eligible for Study: | 1 Month to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication: Recommended:
Patients must have:
NOTE:
Exclusion Criteria
Co-existing Condition:
Patients with the following condition are excluded:
Concurrent Medication:
Excluded:
Excluded within the past 2 years:
Prior Medication:
Excluded:
Study Chair: | Lambert JS | |
Study Chair: | Katz S |
Study ID Numbers: | ACTG 218 |
Study First Received: | November 2, 1999 |
Last Updated: | October 25, 2005 |
ClinicalTrials.gov Identifier: | NCT00000762 |
Health Authority: | United States: Federal Government |
Vaccines, Synthetic HIV Envelope Protein gp160 HIV Envelope Protein gp120 AIDS Vaccines HIV Therapeutic Vaccine |
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
Communicable Diseases RNA Virus Infections Slow Virus Diseases |
Immune System Diseases Lentivirus Infections Infection |