Observation of HIV-Infected Children Receiving Protease Inhibitor and Reverse Transcriptase Inhibitor

Completed

Conditions studied: HIV Infection

In brief

This study will continue to follow children who participated in an earlier National Cancer Institute trial of HIV treatment with a protease inhibitor. Children in this study will receive a combination of at least three drugs that include at least one protease inhibitor and one reverse transcriptase inhibitor. The study will examine to what extent these drugs can restore immune function in HIV-infected children and over what length of time. It will look at changes in the amounts of virus and the specific types of immune cells in the body over the 96-week trial period. It will also examine patients' immune system response to influenza and tetanus vaccinations. The children will either continue to receive the anti-HIV drugs they have been taking, or their medicines will be changed to a different combination of protease inhibitor and reverse transcriptase inhibitor. Before and during the study, patients will undergo various tests, including a physical examination, blood tests and chest X ray, immune response tests, CT scan, eye examination, electrocardiogram and echocardiogram. A procedure called apheresis may be done to collect white blood cells. In this procedure, whole blood is drawn similar to donating blood, the white cells are separated out by a machine, and the red cells are returned to the body.

Key facts

Study ID

NCT00001826

Run by

National Cancer Institute (NCI)

People needed

50

Starts

1999-07-01

Expected to finish

2006-05-01

Last updated by the study team

2008-03-04

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• National Cancer Institute (NCI) — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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