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

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.