OPTICA - INCLUSION CRITERIA: For patients new to IL-2 therapy who are not rolling over from participation in an earlier NIAID/CCMD IL-2 trial.
Documentation of HIV-1 infection by any licensed ELISA test kit and confirmed by a second method (e.g., Western Blot); or by HIV culture, plasma HIV RNA, or proviral HIV DNA.
Absolute CD4+ cell count: there is not a minimum CD4+ cell entry criterion.
Viral Load: there is no viral load restriction upon study entry.
Age greater than or equal to 18 years.
Patients must be of unique immunologic interest or are being recruited to address a research question requiring patients not presently or previously treated with IL-2.
The following laboratory values must be met within 30 days prior to entry:
a. AST no more than 5 X the upper limit of normal (ULN).
b. Total or direct bilirubin no more than 2 X ULN unless there is a pattern consistent with Gilbert's syndrome or the patient is receiving indinavir or atazanavir.
c. Serum creatinine no more than 2.0 mg/dL.
d. Hct greater than or equal to 30.0%.
e. Platelet count greater than or equal to 50,000/mm(3).
Willing to take combination ARV medication at least within a 10-day period surrounding each IL-2 cycle unless or until the protocol is modified to permit IL-2 therapy in the absence of any ARV coverage.
Able to provide written informed consent.
Because the impact of IL-2 on fertility and/or offspring is unknown, all patients, both male and female, must be willing to practice effective birth control at least during a 10-day period surrounding each IL-2 cycle while in the study.
Cycle frequency: There is no minimum requirement for IL-2 cycle frequency. However, a reasonable expectation should exist that IL-2-treated patients will remain willing to accept additional IL-2 therapy when needed.
OPTICA - EXCLUSION CRITERIA:
A history of gross noncompliance with prior NIAID/CCMD protocol requirements that, in the opinion of the Principal Investigator, is likely to seriously compromise the safety or value of an individual's participation in the present protocol.
Any organic CNS abnormality that requires treatment with anti-seizure medication.
Current or historical Crohn's disease, psoriasis, or other autoimmune/inflammatory diseases with potentially life threatening complications.
Significant cardiac, pulmonary, kidney, rheumatologic, gastrointestinal, or CNS disease as detectable on routine history, physical examination, or screening laboratory studies that, in the judgment of the Principle Investigator, may pose an unacceptable risk during subsequent IL-2 therapy.
Psychiatric illness that, in the judgement of the Principal Investigator, might interfere with study compliance or poses a significant risk for exacerbation during subsequent IL-2 therapy.
Recent or active substance abuse that may interfere with protocol compliance or compromise patient safety.
Refusal to practice safer sex or use precautions against pregnancy (effective birth control or abstinence) during cycling.
Refusal to follow Clinical Center policy on partner notification.
History of optic neuritis.
Refusal to permit extra research blood specimens to be stored (frozen) for potential use in the future study of HIV-1 infection or the immune system.
ICARUS - INCLUSION CRITERIA: For patients who are rolling over from participation in an earlier NIAID/CCMD IL-2 trial
Prior documentation of HIV-1 infection by any licensed ELISA test kit and confirmed by a second method (e.g., Western Blot); or by HIV culture, plasma HIV RNA, or proviral HIV DNA.
Absolute CD4+ count: there is not a minimum CD4+ cel entry criterion.
Viral load: there is no viral load restriction upon study entry.
Age at least 18 years.
Current participation, and presently in good standing, in an NIAID/CCMD protocol involving the use of IL-2 in the treatment of HIV-1 infection.
If eligibilble for IL-2 therapy, willing to take combination ARV medication at least within a 10-day period surrounding each IL-2 cycle unless or until the protocol is modified to permit IL-2 therapy in the absence of any ARV coverage.
Able to provide written informed consent.
Both male and females must be willing to practice effective birth control at least during a 10-day period surrounding each IL-2 cycle while in the study.
Cycle frequency: There is no minimum requirement for IL-2 cycle frequency.
ICARUS - EXCLUSION CRITERIA:
A history of gross noncompliance with prior NIAID/CCMD protocol requirements that, in the opinion of the Principal Investigator, is likely to seriously compromise the safety or value of an individual's participation in the present protocol.
Any organic CNS abnormality that requires treatment with anti-seizure medication.
Unless previously exempted for this requirement, current or historical Crohn's disease, psoriasis, or other autoimmune/inflammatory diseases with potentially life-threatening complications.
Recent or active substance abuse that may interfere with protocol compliance or compromise patient safety.
Refusal to practice safer sex or use precautions against pregnancy (effective birth control or abstinence) during cycling.
Refusal to follow Clinical Center policy on partner notification.
History of optic neuritis.
Refusal to permit extra research blood specimens to be stored (frozen) for potential use in the future study of HIV-1 infection or the immune system.
National Institutes of Health Clinical Center
Bethesda, Maryland 20892. Last update: 01/30/2009