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Phase I Study to Evaluate the Safety and Immunogenicity of HIV-1 Immunogen in Children With HIV-1 Infection


Phase 1
N/A
N/A
Not Enrolling
Both
HIV Infection

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Trial Information

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.

Inclusion Criteria


Children between the ages of 3 months and 18 years.

Diagnosis of HIV-1 infection as defined by the Centers for Disease Control (CDC)
Definition. Children and adolescents with vertically, transfusion or sexually acquired
HIV-1 infection are eligible.

Availability of a parent or guardian to provide Informed Consent.

ARM A:

Children and adolescents with vertically, transfusion or sexually acquired HIV-1
infection.

No or moderate immune suppression at the time of study entry as defined by the CDC
Classification System, Immune Categories 1 and 2.

No history of or indication for antiretroviral intervention at time of enrollment or not
receiving antiretroviral treatment because: (a) the patient has elected to decline
treatment or (b) in the opinion of the patient's health care provider, antiretroviral
treatment is not currently recommended because of the patient's inability to adhere to
therapy, promoting the development of viral resistance.

Children younger than 24 months of age must not have had plasma HIV-1 RNA levels greater
than 8 X 10(4) copies/ml previously and at the time of initial evaluation, confirmed at
least at two different time points 2 to 4 weeks apart, showing no sign of increase
(increment less than 0.5 log(10). If the child has had plasma HIV-1 RNA levels greater
than 8 X 10(4) copies/ml at some point prior to the initial evaluation, he/she will have
to be placed on antiretroviral treatment and must meet all the criteria for Arm B.

ARM B:

Children and adolescents with vertically, transfusion, or sexually acquired HIV-1
infection, who are on or have received antiretroviral treatment of longer than 7 weeks.

No or moderate immune suppression at the time of study entry as defined by CDC
Classification System, Immune Categories 1 and 2.

Children younger than 24 months or age, who meet all the inclusion criteria for army B
must have plasma HIV-1 RNA levels less than 5 X 10(4) copies/ml while receiving optimal
antiretroviral therapy, confirmed at least two different time points 2 to 4 weeks apart,
showing no sign of increase (increment less than 0.5 log(10). If the child has been
previously treated with antiretroviral drugs for more than 7 weeks (therefore not eligible
for arm A) and is currently off drugs, he/she will have to be placed on optimal
antiretroviral agents and will have to maintain viral RNA levels below 5 X 10(4) copies/ml
prior to the entry.

Each child enrolled in arm B has to be on constant regimen of antiretroviral treatment for
at least 6 weeks-prior to the first inoculation. Children in immune categories 1 and 2 at
the time of study entry will be allowed to enroll.

Not critically ill or clinically unstable or no presence of active infection requiring
on-going (or induction) therapy.

No evidence of severe immune suppression at the time of study entry as defined by CDC
classification system, Immune Category 3.

For children younger than 24 months of age, no plasma HIV-1 RNA levels greater than or
equal to 5 x 10(4) copies/ml despite appropriate antiretroviral treatment, confirmed at
least at two different time points 2 to 4 weeks apart.

No use of tube feeding or intravenous hyperalimentation itself will be allowed as long as
it is a stable regimen.

No administration of chemotherapeutic agents, or use of immunomodulating agents such as
corticosteroids, interferons, G-CSF, EPO, growth hormone (GH) or IVIG within one month of
enrollment.

No abnormalities of laboratory findings within one month of enrollment including the
following: SGPT or SGOT greater than 5 times the normal value; Total bilirubin greater
than 3 times normal; BUN or creatinine greater than 2 times normal; Total WBC greater than
150/mm(3) or ANC greater than 750/mm(3); Hemoglobin greater than 8.0 g/dl (transfusions
are allowed); Platelet count greater than 100,000/mm(3).

Not pregnant or not planning to become pregnant.

No active substance abuse.

Able to comply with the study requirements for scheduled evaluations such as periodic
clinic visits or blood sampling.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Primary Purpose: Treatment

Authority:

United States: Federal Government

Study ID:

950172

NCT ID:

NCT00001445

Start Date:

August 1995

Completion Date:

July 2001

Related Keywords:

  • HIV Infection
  • Adjuvant-Controlled Study
  • Double Blind Randomization
  • Env-Deleted Inactivated HIV-1
  • Therapeutic HIV Vaccine
  • HIV Infections
  • Acquired Immunodeficiency Syndrome

Name

Location

National Cancer Institute (NCI)Bethesda, Maryland  20892