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



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

For Condition: HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , Genentech
Synopsis: 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.
Details: 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:
Study Type:  Interventional, Treatment, Open Label, Pharmacokinetics Study
Minimum Age/Maximum Age: 1 Year/17 Years
Genders: Both
Protocol Entry 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.
Total Enrollment: 20

Location and Contact Information:

Overall Study Official:
WTShearer,  Study Chair, 

Children's Hosp of Philadelphia
Philadelphia,  Pennsylvania,  191044318
United States
 

Texas Children's Hosp / Baylor Univ
Houston,  Texas,  77030
United States
 


Additional Information:
Study ID Numbers:  ACTG 211; 
Study Start Date: 
Record last reviewed: January 1996
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000761

Other Hiv Infections Studies:
1. Effects of Storage on Lactate in Blood Samples

2. The Effectiveness of Indinavir Plus Zidovudine Plus Lamivudine in HIV-Infected Patients with No Symptoms of Infection

3. A Phase I, Multicenter, Randomized, Double-Blind, Placebo-Controlled HIV-1 Vaccine Trial to Evaluate the Safety and Immunogenicity of MN Recombinant Soluble gp120/HIV-1 (rsgp120/HIV-1) (Genentech) in Combination With QS21 Adjuvant and/or Alum in Healthy Adults

4. A Multicenter Placebo-Controlled Dose Titration Study to Evaluate the Efficacy and Safety of Sandostatin (SMS 201-995) in the Treatment of Patients With Acquired Immunodeficiency Related Diarrhea

5. Pediatric Pulmonary and Cardiovascular Complications of Vertically Transmitted HIV Infection (P2C2)

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