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

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00001445
First received: November 3, 1999
Last updated: March 3, 2008
Last verified: August 2000
  Purpose

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.


Condition Intervention Phase
HIV Infection
Biological: HIV-1 Immunogen
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Primary Purpose: Treatment
Official Title: Phase I Study to Evaluate the Safety and Immunogenicity of HIV-1 Immunogen in Children With HIV-1 Infection

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 32
Study Start Date: August 1995
Estimated Study Completion Date: July 2001
Detailed 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) 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00001445

Locations
United States, Maryland
National Cancer Institute (NCI)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00001445     History of Changes
Other Study ID Numbers: 950172, 95-C-0172
Study First Received: November 3, 1999
Last Updated: March 3, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Adjuvant-Controlled Study
Double Blind Randomization
Env-Deleted Inactivated HIV-1
Therapeutic HIV Vaccine

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
Communicable Diseases
HIV Infections
Infection
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on October 29, 2014