Search / Trial NCT00001445

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

Launched by NATIONAL CANCER INSTITUTE (NCI) · Dec 9, 2002

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Trial Information

Current as of March 05, 2024

Completed

Keywords

Adjuvant Controlled Study Double Blind Randomization Env Deleted Inactivated Hiv 1 Therapeutic Hiv Vaccine

Description

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...

Gender

All

Eligibility 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.

Attachments

readout_NCT00001445_2024-03-05.pdf

4.5 MB

NCT00001445_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Bethesda, Maryland, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

5 stars
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Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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