Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001826
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
Observation of HIV-Infected Children Receiving Protease Inhibitor and Reverse Transcriptase Inhibitor
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2006-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 CD4T lymphocytes will be studied by determining the presence and extent of production of new naive thymic derived CD4T 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 99-C-0134 | None | None | None |