Phase I/II Study of Recombinant Human Interferon-gamma (rIFN-gamma) in HIV-Infected Children

This study has been completed.
Sponsor:
Collaborator:
Genentech
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00000761
First received: November 2, 1999
Last updated: April 27, 2012
Last verified: April 2012
  Purpose

PRIMARY: To determine the safety and toxicity of recombinant interferon gamma-1b ( rIFN-gamma ) in HIV-infected children receiving ongoing zidovudine ( AZT ) or didanosine ( ddI ) therapy. To document HIV-associated defects in neutrophil and/or monocyte function that are improved with rIFN-gamma.

SECONDARY: To determine whether a change in CD4 cell count occurs and to assess virologic status and effects on AZT and ddI pharmacokinetics.

It is likely that infants and children severely immunocompromised by HIV infection would respond to immunomodulators that augment different portions of the host defense system. Interferon-gamma has been shown to benefit children with severely compromised nonspecific immunity and may thus be of benefit to those with HIV infection.


Condition Intervention Phase
HIV Infections
Drug: Interferon gamma-1b
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I/II Study of Recombinant Human Interferon-gamma (rIFN-gamma) in HIV-Infected Children

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 20
Study Completion Date: October 1997
Detailed Description:

It is likely that infants and children severely immunocompromised by HIV infection would respond to immunomodulators that augment different portions of the host defense system. Interferon-gamma has been shown to benefit children with severely compromised nonspecific immunity and may thus be of benefit to those with HIV infection.

Patients are treated with subcutaneous rIFN-gamma 3 times a week for 24 weeks and are then followed for an additional 12 weeks.

  Eligibility

Ages Eligible for Study:   1 Year to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

Concurrent Medication:

Required:

  • AZT or ddI therapy.
  • PCP prophylaxis.

Allowed:

  • Antipyretics.
  • Antiemetics.
  • Antihistamines.
  • Decongestants.
  • Skin creams and lotions.
  • Immunizations according to current recommendations.

Patients must have:

  • Class P-2 symptomatic HIV infection.
  • Ongoing AZT or ddI therapy of 6 months or longer duration.

Exclusion Criteria

Concurrent Medication:

Excluded:

  • Antiretroviral therapy other than AZT or ddI.
  • Chemotherapy for active malignancy.
  • Amphotericin B for systemic fungal infections.

Patients with the following prior conditions are excluded:

  • History of congestive heart failure or arrhythmias.
  • History of congenital heart disease.
  • History of seizure disorder requiring anticonvulsant medication. (NOTE:

History of uncomplicated febrile seizures does not exclude.)

Prior Medication:

Excluded within 8 weeks prior to study entry:

  • Immunomodulators other than IVIG.

Prior Treatment:

Excluded:

  • Red blood cell transfusion within 4 weeks prior to study entry.

Required:

  • Ongoing AZT or ddI therapy of 6 weeks or longer duration.
  • Ongoing PCP prophylaxis for more than 6 weeks duration.

Ongoing alcohol or drug use.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000761

Locations
United States, Pennsylvania
The Children's Hosp. of Philadelphia IMPAACT CRS
Philadelphia, Pennsylvania, United States, 191044318
United States, Texas
Texas Children's Hosp. CRS
Houston, Texas, United States, 77030
Sponsors and Collaborators
Genentech
Investigators
Study Chair: WT Shearer
Study Chair: SL Abramson
Study Chair: MW Kline
  More Information

Publications:
Kline MW, Fletcher CV, Douglas SD, Fenton T, Shearer WT. Recombinant human interferon-gamma (rIFN-gamma) treatment of HIV-infected children. Conf Retroviruses Opportunistic Infect. 1997 Jan 22-26;4th:143 (abstract no 424)

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00000761     History of Changes
Other Study ID Numbers: ACTG 211, 11188
Study First Received: November 2, 1999
Last Updated: April 27, 2012
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Interferon-gamma, Recombinant
Acquired Immunodeficiency Syndrome
AIDS-Related Complex

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Interferon-gamma
Interferons
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents

ClinicalTrials.gov processed this record on August 27, 2014