Correlation of HIV Levels With Clinical and Immunologic Outcome in Children Treated With Didanosine
Completed
Conditions studied: HIV Infection
In brief
Recent studies have shown that patients receiving state-of-the-art treatment for HIV infection (highly active antiretroviral therapy, or HAART) show discordant responses to therapy-that is, they improve both clinically and immunologically (increased CD4 immune cell counts), but their levels of HIV in the blood do not drop. This study will examine blood samples taken from HIV-infected children treated with 2',3'-dideoxyinosine (didanosine, or ddI) in an earlier NCI study to determine if these patients had similar discordant responses to therapy. If so, the study will also examine how these factors may be predictive of disease progression and survival. Investigators will measure HIV levels in blood specimens from children previously enrolled in NCI protocol 88-C-0129. The measurements will be done in specimens drawn before initiation of treatment with ddI and at various times during the course of treatment. The viral responses to therapy will then be correlated with short- and long-term clinical and immunologic outcomes. In addition, researchers will examine these patients' blood samples for additional factors recently discovered to potentially influence disease progression. They include selenium levels and certain genetic factors. A better understanding of discordant responses to therapy will help physicians determine the best treatment option in situations where therapy results do not show uniform benefit. This protocol involves the scientific examination of laboratory specimens only and is not a clinical study open to patient enrollment.
Key facts
- Study ID
- NCT00026676
- Run by
- National Cancer Institute (NCI)
- People needed
- 82
- Starts
- 2000-05-01
- Expected to finish
- 2003-04-01
- Last updated by the study team
- 2008-03-04
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Prior enrollment on NCI protocol 88-C-0219, a phase I/II study of 2',3'- dideoxyinosine (ddI) in children with human immunodeficiency virus infection.
- Informed consent for participation in 88-C-0219 clinical trial.
- Adequate available clinical and immunologic data and banked blood specimen components obtained during implementation of the protocol.
Where it is running
- National Cancer Institute (NCI) — Bethesda, Maryland, United States
Full record on ClinicalTrials.gov
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