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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00001826
Recruitment Status : Completed
First Posted : November 4, 1999
Last Update Posted : March 4, 2008
Information provided by:
National Institutes of Health Clinical Center (CC)

Brief Summary:

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.

Condition or disease
HIV Infection

Detailed Description:
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.

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Study Type : Observational
Enrollment : 50 participants
Official Title: A Long-Term Observational Study of Immunologic Reconstitution in HIV-1 Infected Children Who Are Receiving Combination Protease Inhibitor and Reverse Transcriptase Inhibitors
Study Start Date : July 1999
Study Completion Date : May 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


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.


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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00001826

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

Layout table for additonal information Identifier: NCT00001826     History of Changes
Other Study ID Numbers: 990134
First Posted: November 4, 1999    Key Record Dates
Last Update Posted: March 4, 2008
Last Verified: May 2006

Keywords provided by National Institutes of Health Clinical Center (CC):
CD-4-Naive T Cells
CD-4-Memory T Cells
Antiviral Activity
VB Repertoire
Treatment Experienced

Additional relevant MeSH terms:
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HIV Infections
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immune System Diseases
Protease Inhibitors
HIV Protease Inhibitors
Reverse Transcriptase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Nucleic Acid Synthesis Inhibitors