Pharmacodynamics of Intermittent IL-2 Infusions in HIV Seropositive Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00001474
• Date of registration: 03/11/1999
• Primary sponsor: National Institute of Allergy and Infectious Disease (NIAID)
• Public title: Pharmacodynamics of Intermittent IL-2 Infusions in HIV Seropositive Patients
• Scientific title: Pharmacodynamics of Intermittent IL-2 Infusions in HIV Seropositive Patients
• Date of first enrolment: May 1995
• Target sample size: 36
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00001474
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment

Countries of recruitment

United States

Key inclusion & exclusion criteria

Patients must meet all the following to be eligible for study entry:

Documented HIV infection (ELISA and Western blot positive).

18 years or older.

Karnofsky performance status greater than or equal to 70.

CD4 cell count between 200 and 500 cells/mm(3).

Negative urine or serum pregnancy test within 7 days prior to study entry for women of
childbearing potential.

Patients must be receiving a stable FDA approved antiretroviral regimen for at least 2
weeks prior to study entry.

SGOT less than or equal to 150 u/l.

Total bilirubin less than or equal to 2.0 mg/dl.

Serum creatinine less than or equal to 2.0 mg/dl.

Proteinuria less than or equal to 1+.

Granulocyte count greater than or equal to 1,000/mm(3).

Hemoglobin greater than or equal to 10 gm/dl and platelet count greater than or equal to
75,000.

Patients should have a companion who is willing to monitor the outpatient infusions of
IL-2.

Patient must sign an informed consent conforming to FDA and institutional guidelines.

No prior IL-2 therapy.

No malignancy other than mucocutaneous Kaposi sarcoma.

No history of prior AIDS-defining opportunistic infection.

No current history of alcohol or substance abuse, or dependence that in the opinion of the
screening team may affect patient safety or compliance.

No patients exhibiting psychiatric or cognitive disturbance or illness, which in the
assessment of the protocol team may affect patient safety or compliance.

No clinically significant cardiac, thyroid, pulmonary, kidney or CNS impairment.

No hypertension requiring anti-hypersensitive therapy.

No use of systemic corticosteroids, chemotherapy, or experimental therapy in the prior 4
weeks.

No pregnant or lactating patients.

No patients who are likely to require treatment with G-CSF, GM-CSF, or interferons.

No patients with a history of Crohn's disease or autoimmune diseases with potentially
life-threatening complications.

No patients with avascular necrosis of the bone.

Home - patient must be enrolled and in good standing on a current NIAID protocol involving
the use of IL-2 therapy. The patient must already have undergone at least one year of
treatment on the protocol during with IL-2 therapy has been given, including at least 2
well-tolerated outpatient cycles of scIL-2 at a stable dose.

Home - The patient must have a history of generally tolerable side effects while receiving
IL-2 that did not require frequent medical interventions, intravenous fluid replacement,
and/or IL-2 dose reductions. Conditions generally not suitable for home scIL-2
administration would include (but are not limited to) an unusually heavy requirement for
narcotic usage during a cycle, significant urticaria (hives) or other allergic conditions,
and any history of possible airway compromise due to throat swelling.

Home - Patient must not have experienced any serious (grade 3 or higher) clinical or
laboratory abnormalities of medical significance during days 0-5 of the last 2 outpatient
scIL-2 cycles.

Home -The patient must have a strong relationship with a private physician or health-care
provider at home who has demonstrated close involvement in the patient's care to date and
who would be willing to help supervise a patient's care during each home scIL-2 cycle.
Because of the need to identify a single health-care provider at home who will agree to be
available to render care (if needed) during a patient's scIL-2 cycle, patients who
currently receive their home care from rotating staff members in a general clinic setting
may not be eligible for home scIL-2 administration. A signed written statement
acknowledging willingness to participate in monitoring must be received by the clinic 8
study team from the private physician or health-care provider prior to the first home
scIL-2 cycle. In addition, communication must occur between your clinic 8-study team and
the designated physician or health-care provider prior to each subsequent cycle to confirm
that individual's continued willingness to serve as on-site provider for any serious
medical conditions that might develop during a cycle.

Home - The patient must live at a home address with easy access to a telephone and must
have demonstrated reliability in responding to telephone calls from clinic 8 staff
members. The patient must also be able to provide the study team with reliable contact
information for a close family member or friend who will agree to serve in the capacity of
a "care-giver" during each cycle: i.e. someone who will be able to render non-medical
assistance to the patient and be able to check on their condition daily in the event that
emergency medical assistance needs to be summoned. It will become the patient's
responsibility to ensure that the local "care-giver" communicates their willingness to
serve in this capacity by telephoning the clinic 8-study team prior to each cycle.

Home -The patient must have "reasonable" (i.e. rapid and close) access at home to
emergency medical services and a nearby medical facility in the event of a medical crisis.
The suitability of the at-home situation will be assessed on a case-by-case basis by the
clinic 8-study team.

Home - The patient must have demonstrated reliability and consistency in sterile
technique, the reconstitution of IL-2 vials, and the administration of scIL-2 injections.

Home - The patient must be receiving outpatient scIL-2 cycles at least once every 6 months
as part of their normal protocol participation, except at the discretion of the study
team.

Home - The patient must have access to a reliable home weight scale and be able to weigh
themselves accurately on a daily basis for the purposes of safety monitoring.



Age minimum: N/A
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

HIV Infection

Intervention(s)

Drug: Interleukin-2

Secondary ID(s)

95-I-0114

950114

Source(s) of Monetary Support

Please refer to primary and secondary sponsors