Search / Trial NCT00001475

Home Treatment of HIV-Infected Patients With Interleukin-2 With or Without a Tumor Necrosis Factor Antagonist

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Nov 3, 1999

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Trial Information

Current as of December 10, 2023

Completed

Keywords

Aids Cytokines Thalidomide Monoclonal Antibody Immunomodulator

Description

In the initial phase of this study, HIV-infected patients with CD4 counts between 200 and 500 were randomized to receive either IL-2 alone by continuous IV infusion for 5 days every 8 weeks, IL-2 plus anti-TNF antibody, or IL-2 plus thalidomide. The primary endpoints of this study are safety and tolerability of the IL-2/TNF inhibitor combination. Secondary endpoints will include changes in CD4 counts, frequency and severity of IL-2 related side effects, changes in serum TNF levels, and plasma viral load changes. The study period is one year, with an optional extension period to follow. Enro...

Gender

All

Eligibility criteria

  • IL-2 NAIVE PATIENTS:
  • Documented HIV-1 infection (ELISA and Western blot positive).
  • 18 years or older.
  • CD4 count greater than or equal to 200 cells per mm(3) and less than or equal to 500 cells/mm(3)
  • Clinical laboratory values Grade 0 or 1.
  • No therapy with corticosteroids, chemotherapy, pentoxifylline, thalidomide, or experimental therapy in the prior 4 weeks.
  • Negative urine pregnancy test within 2 weeks prior to study entry (for women of childbearing potential).
  • Current treatment with a stable regimen or licensed anti-retroviral therapy for at least 2 weeks.
  • Adequate venous access in the upper extremities for repeated blood drawing and intravenous catheter placement.
  • No prior IL-2 therapy.
  • No malignancy other than Kaposi's sarcoma. Patients with Kaposi's sarcoma are eligible, but most not have received systemic therapy for KS within 4 weeks prior to study entry.
  • No history of prior AIDS-defining opportunistic infection other than pulmonary TB or recurrent pneumonia.
  • No active substance abuse which may affect patient safety or compliance.
  • No patients exhibiting psychiatric disturbance or illness which in the assessment of the protocol team may affect patient safety or compliance.
  • No patients with significant cardiac, pulmonary, rheumatologic, thyroid, kidney, gastrointestinal or neurological disease that could either decrease absorption of oral therapy, prove a cardiovascular risk during the fluid shifts and stresses that occur with IL-2 therapy, or that could have an inflammatory/immune etiology and thus might be activated or worsened by IL-2.
  • No patients with hypertension requiring continuous anti-hypertensive therapy.
  • No pregnant or lactating patients.
  • Women of childbearing potential must agree to practice abstinence or use 2 forms of contraception simultaneously beginning 1 month prior to receiving study medication and continuing thereafter until 1 month after the last dose of study medication.
  • Men must agree to practice abstinence or use a condom when engaging in intercourse during the same time period.
  • Must be willing 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-1 seropositivity and the risk of transmission of HIV-1 infection.
  • No history of hypersensitivity or intolerance to either IL-2 or thalidomide.
  • PRIOR IL-2 THERAPY PATIENTS:
  • Active participation in protocols 91-CC-0113 or 93-CC-0143.
  • Negative urine pregnancy test within 2 weeks prior to study entry (for women of childbearing potential).
  • No history of hypersensitivity or intolerance to thalidomide.

Attachments

readout_NCT00001475_2023-12-10.pdf

4.5 MB

NCT00001475_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Bethesda, Maryland, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

5 stars
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Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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