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A Randomized Trial of Interleukin-2 With or Without a Tumor Necrosis Factor Antagonist in Patients With HIV-1 Infection


Phase 2
N/A
N/A
Not Enrolling
Both
Acquired Immunodeficiency Syndrome, HIV Infection

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Trial Information

A Randomized Trial of Interleukin-2 With or Without a Tumor Necrosis Factor Antagonist in Patients With HIV-1 Infection


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. Enrollment was for up to forty-five
IL-2-naive patients.

In the amended phase of this study, up to 60 patients with HIV infection and CD4 counts
equal to or greater than 350 will be studied to determine the ability of prednisone to
ameliorate IL-2 related toxicity. Patients will be randomized to one of four groups: IL-2
alone; IL-2 plus prednisone; prednisone alone; no treatment. All four groups will be
treated with a combination regimen of antiretrovirals to include at least one protease
inhibitor. IL-2 will be dosed SQ at a starting dosage of 7.5 mlU bid x 5 days every 8
weeks, and prednisone (or placebo) will be dosed at 0.5 mg/kg/day during IL-2 cycles.
Primary endpoints are frequency of IL-2 associated fatigue and fever, CD4 count changes, and
viral load changes. Secondary endpoints include frequency of other IL-2 side effects,
concomitant medication use, steroid associated side effects, cytokine changes during IL-2,
and IL-2 total exposure in the IL-2 plus steroid vs. IL-2 plus placebo arms. The study
period is one year with an optional extension period to follow.

Inclusion 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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment

Authority:

United States: Federal Government

Study ID:

950133

NCT ID:

NCT00001475

Start Date:

June 1995

Completion Date:

June 2002

Related Keywords:

  • Acquired Immunodeficiency Syndrome
  • HIV Infection
  • AIDS
  • Cytokines
  • Thalidomide
  • Monoclonal Antibody
  • Immunomodulator
  • Acquired Immunodeficiency Syndrome
  • HIV Infections
  • Immunologic Deficiency Syndromes
  • Necrosis

Name

Location

National Institute of Allergy and Infectious Diseases (NIAID)Bethesda, Maryland  20892