Clinical trial NCT00000761: Phase I/II Study of Recombinant Human Interferon-gamma (rIFN-gamma) in HIV-Infected Children
Official title: Phase I/II Study of Recombinant Human Interferon-gamma (rIFN-gamma) in HIV-Infected Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV Infections
Keywords: Interferon-gamma, Recombinant
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
Collaborators: name: Genentech, Inc.
First posted: 2001-08-31
Enrollment: 20
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: 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.

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 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: The Children's Hosp. of Philadelphia IMPAACT CRS
state: Pennsylvania
city: Houston
country: United States
facility: Texas Children's Hosp. CRS
state: Texas
Study officials:
name: WT Shearer
role: STUDY_CHAIR
name: SL Abramson
role: STUDY_CHAIR
name: MW Kline
role: STUDY_CHAIR
References:
citation: 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)
citation: Shearer WT, Kline MW, Abramson SL, Fenton T, Starr SE, Douglas SD. Recombinant human gamma interferon in human immunodeficiency virus-infected children: safety, CD4(+)-lymphocyte count, viral load, and neutrophil function (AIDS Clinical Trials Group Protocol 211). Clin Diagn Lab Immunol. 1999 May;6(3):311-5. doi: 10.1128/CDLI.6.3.311-315.1999.