A Study to Evaluate the Effects of Interleukin-12 (rhIL-12) in HIV-Positive Patients With CD4 Cell Counts Less Than 50 Cells/mm3 or 300-500 Cells/mm3

NCT00000857 | Completed Phase 1

• 2 other identifiers: ACTG 32511299
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 16

Brief Summary

The purpose of this study is to determine the tolerance and effectiveness of rhIL-12 in HIV-positive patients with CD4 cell counts less than 50 cells/mm3 versus 300-500 cells/mm3. This study will look at the ability of rhIL-12 to boost the immune system against HIV and HIV-associated bacterial infections in these patients. IL-12 is found naturally in the body and rhIL-12 is the commercially produced version. IL-12 may enhance anti-HIV immune system activity by increasing the number of cells that fight infection. IL-12 may also increase the body's ability to fight bacterial infections such as Mycobacterium avium complex (MAC).

Conditions

HIV Infections

Keywords

Recombinant Proteins; T-Lymphocytes; Dose-Response Relationship, Drug; Mycobacterium avium Complex; CD4 Lymphocyte Count; Interleukin-12; Killer Cells, Natural; Th1 Cells; Interferon Type II

Interventions

Interleukin-12 DRUG

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• You may be eligible for this study if you:
• Are HIV-positive.
• Are 18-60 years old.
• Have a CD4 count less than 50 cells/mm3 or between 300-500 cells/mm3 within 30 days of study entry.
• Are expected to live at least 12 weeks.
• Agree to practice abstinence or use effective methods of birth control during the study.

You may not qualify if:

• You will not be eligible for this study if you:
• Have a history of cytomegalovirus (CMV) end-organ disease.
• Have a history of invasive fungal disease, unless the condition has been stable for 2 months.
• Have a history of severe allergic reactions to IL-2 or IL-12.
• Have a history of heart problems, autoimmune or rheumatologic disease, gastrointestinal bleeding, or any condition that would keep you from completing the study.
• Have MAC-related symptoms (fever, weight loss, frequent diarrhea) for at least 2 months prior to study entry.
• Are enrolled in another experimental research treatment study.
• Abuse alcohol or drugs.
• Are pregnant or breast-feeding.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (16)

UCLA CARE Center CRS

Los Angeles, California, 90095, United States

Location

USC CRS

Los Angeles, California, United States

Location

Stanford CRS

Palo Alto, California, United States

Location

Ucsf Aids Crs

San Francisco, California, United States

Location

Harbor-UCLA Med. Ctr. CRS

Torrance, California, 90502, United States

Location

Northwestern University CRS

Chicago, Illinois, 60611, United States

Location

Rush Univ. Med. Ctr. ACTG CRS

Chicago, Illinois, 60612, United States

Location

Weiss Memorial Hosp.

Chicago, Illinois, 60640, United States

Location

Indiana Univ. School of Medicine, Infectious Disease Research Clinic

Indianapolis, Indiana, United States

Location

Massachusetts General Hospital ACTG CRS

Boston, Massachusetts, 02114, United States

Location

Beth Israel Deaconess Med. Ctr., ACTG CRS

Boston, Massachusetts, 02215, United States

Location

NY Univ. HIV/AIDS CRS

New York, New York, 10016, United States

Location

Univ. of Rochester ACTG CRS

Rochester, New York, 14642, United States

Location

Unc Aids Crs

Chapel Hill, North Carolina, United States

Location

Hosp. of the Univ. of Pennsylvania CRS

Philadelphia, Pennsylvania, 19104, United States

Location

University of Washington AIDS CRS

Seattle, Washington, 98104, United States

Location

Related Publications (1)

• Jacobson MA, Spritzler J, Landay A, Chan E, Katzenstein D, Schock B, Fox L, Roe J, Kundu S, Pollard R; AACTG 325 Protocol Team. A Phase I, placebo-controlled trial of multi-dose recombinant human interleukin-12 in patients with HIV infection. AIDS. 2002 May 24;16(8):1147-54. doi: 10.1097/00002030-200205240-00008.

  PMID: 12004273 BACKGROUND

MeSH Terms

Conditions

HIV Infections; Mycobacterium avium-intracellulare Infection

Interventions

Interleukin-12

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Mycobacterium Infections, Nontuberculous; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses

Intervention Hierarchy (Ancestors)

Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Mark Jacobson

  STUDY CHAIR

• Richard Pollard

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: DOUBLE
• Purpose: TREATMENT
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Study Completion: June 1, 2001
• Last Updated: October 29, 2021

Record last verified: 2021-10

Locations

US (16)