A Phase I/II Trial of Ribavirin (With Escalation) + Isoprinosine in Asymptomatic HIV-Viremic Patients
Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
To determine the safety and effectiveness of treatment with ribavirin (RBV) plus isoprinosine
(INPX) in preventing the development of AIDS in patients infected with the AIDS virus (HIV).
Also to determine the maximal dose of RBV that can be tolerated by HIV-infected patients when
RBV is given with INPX. The patients may or may not have generalized lymphadenopathy syndrome
(LAS). RBV has prevented the development of AIDS in some HIV-infected patients with LAS and
INPX has stimulated the immune system of patients infected with HIV. The immune system fights
infections in the human body, and the HIV attacks T cells that are an important part of the
immune system. Reports from individual cases treated with both RBV and INPX suggest that
clinical improvements occurred in HIV-infected patients, but there is no reliable information
on the safety and effectiveness of this drug combination in such patients.
Phase:
Phase 1
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)