Interleukin-2 Therapy for HIV Infection - Supplemental Procedures
|First Submitted Date ICMJE||November 3, 1999|
|First Posted Date ICMJE||November 4, 1999|
|Last Update Posted Date||March 4, 2008|
|Start Date ICMJE||March 1993|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00001354 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Interleukin-2 Therapy for HIV Infection - Supplemental Procedures|
|Official Title ICMJE||A Randomized Trial of Interleukin-2 Therapy in HIV-Infected Patients|
Certain patients who are participating in NIH protocols involving interleukin-2 (IL-2) therapy for HIV disease may be requested to have the following changes or additions to their study protocol:
|Detailed Description||This study is designed as a randomized, open label trial to evaluate the effect of interleukin-2 (IL-2) on CD4 counts in patients with HIV infection and CD4 counts above 200 cells/mm(3). 60 patients will receive either antiretroviral therapy or antiretroviral therapy plus IL-2 administered by continuous infusion at a dose of 18 million international units (IU)/day for 5 days every two months for 1 year. Patients will be seen at the NIH every 4 weeks, at which time immune parameters, including CD4 number and percent, will be determined.|
|Study Type ICMJE||Interventional|
|Study Phase||Phase 2|
|Study Design ICMJE||Primary Purpose: Treatment|
|Intervention ICMJE||Drug: Interleukin-2/Zidovudine (AZT)|
|Study Arms||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Estimated Completion Date||March 2002|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
Patients must have documented HIV infection (ELISA and Western blot positive).
Patients must be 18 years or older.
Patients must have CD4 count greater than 200 cells/mm(3).
Patients must have clinical laboratory values Grade 0 or 1.
Patients must not have therapy with corticosteroids, chemotherapy, or experimental therapy in the prior 4 weeks.
Patients must have a negative urine pregnancy test (women of childbearing potential).
Patients with prior IL-2 therapy will be excluded.
Patients with malignancy other than Kaposi sarcoma will be excluded. Patients with Kaposi sarcoma are eligible, but must not have received systemic therapy for KS within 4 weeks prior to study entry.
Patients with history of prior AIDS-defining opportunistic infection will be excluded.
Patients with active substance abuse which may affect patient safety or compliance will be excluded.
Patients exhibiting psychiatric disturbance or illness, which in the assessment of the protocol team may affect patient safety or compliance will be excluded.
Patients with significant cardiac, pulmonary, thyroid, kidney, rheumatologic, or CNS disease will be excluded.
Patients with hypertension requiring anti-hypersensitive therapy will be excluded.
Pregnant or lactating patients or patients of childbearing potential, will be excluded, unless they use effective contraception.
Patients unwillingness to comply with current NIH Clinical Center guidelines concerning appropriate notification by an individual of current or ongoing sexual partners and/or needle-sharing partners regarding his or her HIV seropositivity and the risk of transmission of HIV infection will be cause for exclusion.
|Ages||Child, Adult, Senior|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT00001354|
|Other Study ID Numbers ICMJE||930113
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Institute of Allergy and Infectious Diseases (NIAID)|
|Collaborators ICMJE||Not Provided|
|Investigators ICMJE||Not Provided|
|PRS Account||National Institutes of Health Clinical Center (CC)|
|Verification Date||March 2002|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP