To determine the safety and tolerance of methotrexate in HIV-infected patients. To determine
the dose effective in modulating key markers of immune activation. To determine a dose
suitable for Phase II or III evaluation in HIV-infected patients.
In HIV infection, complete immunological clearance of the foreign antigen does not occur,
resulting in chronic immune activation. Because chronic immune activation may contribute to
disease progression in HIV infection, immunomodulators may have therapeutic value in early
HIV disease prior to development of opportunistic infections. The clinical benefits of
methotrexate appear to derive from an anti-inflammatory effect; thus, it may reduce the state
of chronic immune activation.
Phase:
Phase 1
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)