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A Long-Term Observational Study of Immunologic Reconstitution in HIV-1 Infected Children Who Are Receiving Combination Protease Inhibitor and Reverse Transcriptase Inhibitors


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N/A
Not Enrolling
Both
HIV Infection

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Trial Information

A Long-Term Observational Study of Immunologic Reconstitution in HIV-1 Infected Children Who Are Receiving Combination Protease Inhibitor and Reverse Transcriptase Inhibitors


This study will evaluate the extent of immunoreconstitution in children receiving
combination antiretroviral therapy that includes a protease inhibitor and reverse
transcriptase inhibitors. The children who will be evaluated and followed in this study are
those who have previously been studied on other protease inhibitor-containing anti-HIV
protocols within the HIV and AIDS Malignancy Branch. This study will provide a mechanism to
assess the long-term immunologic changes of potent combination therapy in this unique
population and to relate this to the virologic changes. A total of 50 HIV-1 infected
children will be studied. The children enrolled in this protocol will either continue their
current combination of protease inhibitor and reverse transcriptase therapy or, if deemed
clinically appropriate, will be changed to a new, best available combination of protease
inhibitor and reverse transcriptase inhibitors. Long-term immunoreconstitution, defined as
the repopulation of naive CD4+T lymphocytes, will be studied by determining the presence and
extent of production of new naive (thymic derived) CD4+T cells and by the ability of
patients to mount new helper T cell responses after immunization with influenza and tetanus
toxoid. Expansion of T cell receptor will also be explored in subsets of enrolled patients.
In addition, unforeseen toxicities attributable to the use of combination antiretroviral
therapy have been recognized and described in adult patients. This study will evaluate
abnormalities in lipid and glucose metabolism, changes in the distribution of body fat, and
surrogate markers of cardiovascular disease risk in this cohort of pediatric patients.

Inclusion Criteria


INCLUSION CRITERIA

Age greater than 1 year and less than 21 years.

Diagnosis of HIV-1 infection as defined by the Centers for Disease Control (CDC).

Currently on at least a three drug combination that includes a protease inhibitor (PI) and
reverse transcriptase inhibitor (RTI) therapy for at least 6 months.

Patient must have received initial protease inhibitor treatment in studies in the HIV and
AIDS Malignancy Branch but need not be enrolled on another NIH study to be eligible for
this protocol.

Age-adjusted CD4+ T lymphocytes greater than 200 cells/ml.

Measurements of CD4+45RA+ and CD4+45RO+ T lymphocytes taken within 9 weeks of the time of
initiation of protease-inhibitor therapy.

Availability of a parent or guardian to provide informed consent.

EXCLUSION CRITERIA

Critically ill or clinically unstable child.

Patients receiving treatment for an infection that requires prolonged treatment must have
been stable on therapy for at least 14 days prior to study entry.

Administration of chemotherapeutic agents or use of immunomodulating agents such as high
dose corticosteroids, interferons, pentoxifylline, G-CSF/GM-CSF, erythropoietin, growth
hormone and other growth factors within one month of enrollment. However, patients on
anti-inflammatory drugs or stable doses of immunoglobulins (including hyperimmune
immunoglobulin) will be eligible unless the latter are directed at a T-cell specific
antigen.

Sexually active post-menarchal female unwilling to use a barrier method of contraception
or unwilling to remain sexually abstinent.

Patients who, in the opinion of the Protocol Chairperson or Principal Investigator:

may not be likely to benefit from this study,

may be put at undue risk by participation in this study,

are unlikely to comply with the study requirements.

Type of Study:

Observational

Study Design:

N/A

Authority:

United States: Federal Government

Study ID:

990134

NCT ID:

NCT00001826

Start Date:

July 1999

Completion Date:

May 2006

Related Keywords:

  • HIV Infection
  • CD-4-Naive T Cells
  • CD-4-Memory T Cells
  • Antiviral Activity
  • VB Repertoire
  • Immunizations
  • HIV
  • Treatment Experienced
  • HIV Infections
  • Acquired Immunodeficiency Syndrome

Name

Location

National Cancer Institute (NCI)Bethesda, Maryland  20892