Observation of HIV-Infected Children Receiving Protease Inhibitor and Reverse Transcriptase Inhibitor
|ClinicalTrials.gov Identifier: NCT00001826|
Recruitment Status : Completed
First Posted : November 4, 1999
Last Update Posted : March 4, 2008
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|
|Study Type :||Observational|
|Estimated 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|
|Estimated Study Completion Date :||May 2006|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001826
|United States, Maryland|
|National Cancer Institute (NCI)|
|Bethesda, Maryland, United States, 20892|