A Pilot Study of the Immunologic Reconstitution in HIV-1 Infected Children Receiving Highly Active Antiretroviral Therapy With Combination Ritonavir, Nevirapine and Stavudine
This is a pilot study to evaluate the ability of highly active antiretroviral therapy
administered to children with HIV-1 infection to effect immunoreconstitution in children
with HIV-1 infection. In addition, this study will determine the safety of combination
therapy with ritonavir, nevirapine and stavudine (d4T) as well as the anti-HIV activity of
combination therapy with ritonavir, nevirapine and stavudine. A total of 25 HIV-1 infected
children will be studied, including both moderately and severely immunocompromised
individuals. The children will be treated with ritonavir, nevirapine and stavudine or with
predefined drug substitutions in the case of intolerance. Immunoreconstitution, defined as
the repopulation of naive T cells, will be studied by determining the presence and extent of
production of new naive (thymic derived) CD4+ T cells and their T cell receptor repertoire.
Drug pharmacokinetic profiles in this regimen will be examined.
Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment
United States: Federal Government
|National Cancer Institute (NCI)||Bethesda, Maryland 20892|