The purpose of this study is to evaluate the safety and tolerability of giving IL-2 plus
anti-HIV (antiretroviral) therapy to HIV-positive patients with CD4 cell counts (cells of
the immune system that fight infection) of at least 350 cells/mm3. This study will also
examine the ability of antiretroviral therapy combined with IL-2 to boost the immune system.
IL-2, given through injection under the skin, in combination with anti-HIV therapy can
increase CD4 cell counts. This study examines 3 doses of IL-2 in order to determine the
safest and most effective dose to use.
IL-2, administered subcutaneously in combination with antiretrovirals, has resulted in
increased CD4+ cell counts which may retard HIV disease progression. Using a smaller
patient sampling, this Phase II study helps develop the clinical experience needed to
consider formation of a larger, more complete Phase III trial.
Seventy-two HIV-infected patients (previously treated or naive) are randomized independently
to receive either control therapy with antiretrovirals alone OR escalating doses of
subcutaneous interleukin-2 (IL-2) plus antiretrovirals. In the absence of dose-limiting
toxicity (DLT) in at least 9 of 12 patients in Group 1, 12 additional patients are entered
into Group 2 and treated as indicated. In the absence of DLT in 9 of 12 patients in Group 2,
the final 12 patients are entered into Group 3. Those patients enrolled in either of the
first 2 dose groups who complete 3 courses of therapy have their dose escalated to a maximum
dose. A course of treatment is defined as 5 days of IL-2 plus antiretrovirals followed by 7
weeks of antiretroviral therapy alone.
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.
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 the following: cancer (other than Kaposi's sarcoma), an
AIDS-defining illness, a central nervous system abnormality, or an
- Are pregnant or breast-feeding.
- Have ever received IL-2.