HIV Infection Clinical Trial
Official title:
Phase I Study to Evaluate the Safety and Immunogenicity of HIV-1 Immunogen in Children With HIV-1 Infection
This is a single dose, phase I study to evaluate the safety/tolerance and the immunogenicity
of HIV-1 Immunogen, gp120-depleted inactivated HIV-1 preparation in Incomplete Freund's
Adjuvant (IFA), in children with HIV-1 infection. A total of 32 children with HIV-1
infection will be enrolled in the study. Arm A of the study will enroll children who have no
or moderate immune suppression at the time of study entry as defined by CDC classification
and who have no history of and do not require antiretroviral therapy. Antiretroviral
treatment given for less than 7 weeks (up to 6 weeks and 6 days) prior to entry will be
considered as "no history" of treatment (treatment naive). Arm B will enroll children who
have no or moderate immune suppression at the time of study entry as defined by CDC
classification and who are on or have received antiretroviral treatment for more than 7
weeks. In order to assess the age-associated impact on the immune response rate, we plan to
continue to attempt to enroll infants younger than 24 months of age. Children in each arm
will receive 10 units of HIV-1 Immunogen intramuscularly at 0, 3, 6, 9, and 12 months.
Antiretroviral treatment will commence once patients meet the criteria for an initiation of
the treatment as defined in the protocol. All antiretroviral agents that are currently
approved by FDA for clinical indications in HIV-1-infected children (pediatric labeling) are
permitted in the protocol. If the child has been receiving a single agent other than ddI, or
has been on investigational antiretroviral agents, his/her antiretroviral therapy will have
to be changed to an optimal combination regimen of the approved agents at least 6 weeks
prior to the enrollment.
This is a single dose, phase I study to evaluate the safety/tolerance and the immunogenicity
of HIV-1 Immunogen, gp120-depleted inactivated HIV-1 preparation in Incomplete Freund's
Adjuvant (IFA), in children with HIV-1 infection. A total of 32 children with HIV-1
infection will be enrolled in the study. Arm A of the study will enroll children who have no
or moderate immune suppression at the time of study entry as defined by CDC classification
and who have no history of and do not require antiretroviral therapy. Antiretroviral
treatment given for less than 7 weeks (up to 6 weeks and 6 days) prior to entry will be
considered as "no history" of treatment (treatment naive). Arm B will enroll children who
have no or moderate immune suppression at the time of study entry as defined by CDC
classification and who are on or have received antiretroviral treatment for more than 7
weeks. In order to assess the age-associated impact on the immune response rate, we plan to
continue to attempt to enroll infants younger than 24 months of age. Children in each arm
will receive 10 units of HIV-1 Immunogen intramuscularly at 0, 3, 6, 9, and 12 months.
Antiretroviral treatment will commence once patients meet the criteria for an initiation of
the treatment as defined in the protocol. All antiretroviral agents that are currently
approved by FDA for clinical indications in HIV-1-infected children (pediatric labeling) are
permitted in the protocol. If the child has been receiving a single agent other than ddI, or
has been on investigational antiretroviral agents, his/her antiretroviral therapy will have
to be changed to an optimal combination regimen of the approved agents at least 6 weeks
prior to the enrollment.
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Endpoint Classification: Safety Study, Primary Purpose: Treatment
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