Immune Reconstitution of Lopinavir/Ritonavir-Based vs Efavirenz-based HAART in Advanced HIV Disease
Status:
Terminated
Trial end date:
2011-01-01
Target enrollment:
Participant gender:
Summary
The ideal anti-HIV medications for patients with advanced HIV disease is unknown. There is
evidence that anti-HIV regimens that contain protease inhibitors can enhance immune function
better than regimens that do not contain protease inhibitors. This is a study that will
determine the difference in immune enhancement capabilities between an anti-HIV regimen that
contains the protease inhibitor - lopinavir-ritonavir, and a regimen that contains efavirenz.
Both medications are recommended as first line treatments for HIV-infected patients. This
study will recruit HIV-positive patients that need to start anti-HIV treatment because their
CD4+ T-cells are below 200. The usual threshold for starting treatment is a CD4+ T-cell less
than 350. Subjects will be randomized to treatment with either an anti-HIV regimen that
contains lopinavir-ritonavir or a regimen that contains efavirenz. The study will determine
the difference in immune reconstitution over 24 weeks of treatment with study medications.
Among the immune parameters that will be measured is the ability of each subject to respond
to vaccination with the tetanus-diphtheria vaccine and the 23-valent pneumococcal vaccine.
Both vaccines are also recommended for HIV-positive patients but HIV-positive patients tend
to have a lower response rate to these vaccines.
Phase:
Phase 4
Details
Lead Sponsor:
Rush University Medical Center
Collaborators:
Abbott Gilead Sciences Ruth M. Rothstein CORE Center University of Chicago University of Illinois at Chicago