Effects of Giving Interleukin-2 (IL-2) Plus Anti-HIV Therapy to HIV-Positive Patients With CD4 Cell Counts of at Least 350 Cells/mm3

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Keywords

ClinConnect Summary

Interleukin-2 administered subcutaneously, in combination with antiretrovirals, results in an increased CD4+ cell count that might impact upon HIV disease progression. A Phase III trial involving large numbers of HIV-positive patients is the next step in the development process. To develop appropriate clinical experience with this combination, this Phase II trial will allow administration of IL-2 plus antiretroviral therapy to a small number of patients in sites being considered for the Phase III trial.

Patients receive antiretrovirals alone or antiretrovirals plus IL-2 given subcutaneousl...

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• Patients may be eligible for this study if they:
• • Are HIV-positive.
• • Have a CD4 cell count greater than or equal to 300 cells/mm3.
• • Have no AIDS-defining illnesses.
• • Are at least 18 years old.
• • Have been on antiretroviral therapy for at least 7 days prior to study entry.
• • Exclusion Criteria
• Patients will not be eligible for this study if they:
• • Abuse alcohol or drugs, or have any serious psychiatric or medical illnesses that would affect their safety or ability to complete the study.
• • Have a history of cancer (other than Kaposi's sarcoma), an AIDS-defining illness, a central nervous system abnormality, or an autoimmune/inflammatory disease.
• • Are pregnant or breast-feeding.
• • Have ever received IL-2.

Trial Officials