drugset / Trial / NCT00785967

Immune Responses in Patients Treated With Raltegravir

NCT00785967

RandomizedParallel-groupOpen-labelBasic science

Summary

Hypothesis: Treatment with raltegravir does not alter V(D)J recombination or immune responses to neoantigens. A process known as V(D)J recombination is essential for developing lymphocytes and the specific functioning of the immune system. Raltegravir is the first approved drug of the new integrase inhibitor class of anti-HIV drugs. Integrase inhibitors have been shown in some studies to interfere with DNA cleavage and the activities of RAG-1/2. These studies suggest a potential to affect aspects of both B-cell and T-cell development, therefore, it is important to evaluate the potential effects that integrase inhibitors may have in clinical use. If immunoglobulin and T-cell receptor genes are altered by HIV integrase, then patient lymphocytes will fail to display normal responses to vaccinations.

Timeline

Start
2009-01
Primary completion
2011-08
Completion
2011-08

Drugs

EvaluationDrugModalityDoseRoute
Background Pneumovax 23 Vaccine 0.5 ml Intramuscular
Background Vaqta Vaccine 1 ml Intramuscular