a study to evaluate the effects of giving il-2 alone to hiv-positive patients with cd4 cell counts of at least 350 cells/mm3 who do not wish to receive anti-hiv therapy

Conditions: HIV Infections

Summary: the purpose of this study is to evaluate the safety and tolerability of giving interleukin-2 (il-2) alone to hiv-positive patients with cd4 cell counts greater than 350 cells/mm3 who do not wish to receive anti-hiv (antiretroviral) therapy. this study will also determine if il-2 given alone can increase cd4 cell counts or decrease the level of hiv in the blood. il-2 (a protein found in the blood that helps boost the immune system) can result in increases in cd4 cell count (immune system cells that fight infection). il-2 is normally given in combination with antiretroviral therapy to treat hiv infection; however, some hiv patients do not wish to take antiretrovirals. this study asks if it is safe and effective to take il-2 alone to treat hiv infection.

previous studies have shown that interleukin-2, when given under the skin, results in cd4+ cell count increases, and may impact upon disease progression. a phase iii trial is the next step in the development of these efficacy trials. one question, however, has not been addressed in previous il-2 studies: whether it is both safe and reasonable to allow prospective il-2 recipients the autonomy of choosing whether or not to take antiretrovirals in addition to their cytokine therapy. this trial addresses that concern. in this open-label study, 36 patients are randomized to 1 of 3 treatment groups of 12 patients each: group i: il-2 every 12 hours for 5 days every 8 weeks. group ii: il-2 every 12 hours for 5 days every 8 weeks (higher il-2 dose). group iii: control group receiving no therapy. patients must complete a minimum of 3 8-week cycles of treatment. twelve patients are randomized to each arm. following study completion, group i and ii patients may elect to continue receiving il-2 during follow-up or as part of an additional protocol based on the results of this study. \[as per amendment 2/12/99: patients who have received study medication and/or routine protocol visits and procedures for at least 6 months with acceptable compliance are eligible for continued follow-up in an extension phase. the extension phase will continue for at least 1 year from the date when the last patient has been enrolled in the extension phase. patients originally randomized to il-2 may continue to receive il-2 during the extension period, with il-2 therapy guided on an individual basis. patients originally randomized to no therapy may continue to receive no therapy during the extension phase.\] \[as per amendment 7/11/00: patients demonstrating acceptable compliance with routine visits and procedures during the initial treatment phase and/or extension phase may participate in the long-term follow-up phase which requires follow-up visits at least every 4 months for approximately 5 years. patients originally randomized to group 1 or 2 may continue to receive il-2, with il-2 therapy guided on an individual basis, during the long-term follow-up phase. patients originally randomized to group 3 may continue to receive no therapy during the long-term follow-up phase.\]

Eligibility criteria:
inclusion criteria patients may be eligible for this study if they: * are hiv-positive. * have had at least one cd4 cell count greater than or equal to 350 cells/mm3 within 30 days of study entry. * are at least 18 years old. * agree to abstinence or use of effective methods of birth control 1 month before and during the study. exclusion criteria patients will not be eligible for this study if they: * have a history of a potentially life-threatening autoimmune or inflammatory disease. * 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 an aids-defining illness. * have a history of cancer, other than kaposi's sarcoma. * have ever taken il-2 or any antiretroviral medications. * are pregnant. * are taking certain medications, including anti-seizure medications.

Keywords: interleukin-2 dose-response relationship, drug cd4 lymphocyte count rna, viral