The purpose of this study is to compare the effects of subcutaneous recombinant interleukin-2 (rIL-2) administered with and without concomitant peri-cycle highly active antiretroviral therapy to no therapy on CD4+ T lymphocyte count in patients with HIV-1 infection and CD4+ T lymphocyte count greater than or equal to 300/mm(3).

Treatment or Intervention	Phase
Drug: Recombinant Interleukin-2	Phase II

Further Study Details: 

Expected Total Enrollment:  480

The purpose of this study is to compare the effects of subcutaneous recombinant interleukin-2 (rIL-2) administered with and without concomitant peri-cycle highly active antiretroviral therapy to no therapy on CD4+ T lymphocyte count in patients with HIV-1 infection and CD4+ T lymphocyte count greater than or equal to 300/mm(3).

Genders Eligible for Study:  Both

Criteria

INCLUSION CRITERIA:
Documented HIV-1 infection by any licensed ELISA test and confirmed by a second method (e.g. Western Blot); or any one of the following prior to randomization: detectable HIV p24 antigen, quantifiable plasma HIV RNA, or proviral DNA.
Greater than or equal to 18 years of age.
The following clinical laboratories obtained within 45 days prior to randomization:
One CD4+ T cell count greater than or equal to 300 cells/mm(3). (For patients who are status post-splenectomy, also a CD4+ cell percentage on this occasion greater than or equal to 20%);
AST or ALT less than 5 times the upper limit of normal (ULN) range;
Total or direct bilirubin less than or equal to 2 X ULN (patients with hyperbilirubinemia due to Gilbert's syndrome or indinavir or atazanavir therapy may have a serum bilirubin up to 5 X ULN);
Serum creatinine less than or equal to 2 mg/dl (177 micro mol/L);
Sodium within normal limits;
Granulocyte count greater than or equal to 1000/mm(3);
Hemoglobin greater than or equal to 10 gm/dl;
Platelet count greater than or equal to 50,000 cells/mm(3).
Ability to provide informed consent.
Ability to obtain antiretroviral medication.
EXCLUSION CRITERIA:
Any prior history of rIL-2 use.
Use of any approved or experimental antiretroviral drug (including hydroxyurea) within one year prior to randomization.
In the judgment of the clinician, any current indication for continuous antiretroviral therapy, or any contraindication to antiretroviral therapy.
Evidence of virological failure on a protease inhibitor- or nonnucleoside reverse transcriptase-based antiretroviral regimen.
Use of systemic corticosteroids, chemotherapy, or experimental cytotoxic drugs within 45 days prior to randomization.
Use of any agents (approved or experimental) with clinically significant immunomodulatory effects within 8 weeks prior to randomization.
History of any AIDS-defining illness or any of the following conditions: extrapulmonary Pneumocystis carinii disease; multi-dermatomal Herpes zoster (greater than or equal to 10 lesions in a non-contiguous site); American trypanosomiasis (Chagas disease) of the CNS; Penicillium marneffii disease; visceral leishmaniasis; non-Hodgkin's lymphoma of any cell-type; Hodgkin's lymphoma; bartonellosis; microsporidiosis (greater than 1 month's duration); nocardiosis; invasive aspergillosis; or Rhodococcus equi disease.
Concurrent malignancy requiring cytotoxic chemotherapy.
Any CNS abnormality that requires ongoing treatment with antiseizure medication.
Current or historical autoimmune/inflammatory diseases including:
Inflammatory bowel disease, psoriasis, optic neuritis, or any autoimmune/inflammatory diseases with potentially life-threatening complications.
Significant cardiac, pulmonary, renal, hepatic, gastrointestinal, CNS, psychiatric disease or illicit substance use/abuse that in the opinion of the investigator would make the patient a poor candidate for study participation.
Pregnancy (for women of childbearing potential, a negative pregnancy test, urine or serum, is required within 14 days prior to randomization).
Breastfeeding.

Maryland
      National Institute of Allergy and Infectious Diseases (NIAID), 9000 Rockville Pike,  Bethesda,  Maryland,  20892,  United States; Recruiting

Study ID Numbers:  050123; 05-I-0123
Record last reviewed:  February 17, 2004
Last Updated:  March 29, 2005
Record first received:  March 29, 2005
ClinicalTrials.gov Identifier:  NCT00106730
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08