The Safety of Zidovudine Plus Interferon-Alpha in HIV-Infected Children

NCT00000967 | Completed Phase 1

• 2 other identifiers: ACTG 15311128
• Study Type: interventional
• Target: 52
• Locations: 2 countries
• Sites: 9

Brief Summary

PRIMARY: To determine the maximum tolerated dose of interferon-alfa (IFN-A) alone and in combination with zidovudine (AZT); to assess the safety and tolerance of IFN-A alone and in combination with AZT. SECONDARY: To evaluate the effect of combination IFN-A and AZT on immunologic and virologic parameters; to determine whether the pharmacokinetic parameters of AZT are modified by the subcutaneous administration of IFN-A. AZT is effective in suppressing the progression of HIV infection in patients without symptoms or with AIDS or AIDS-related complex (ARC). However, use of AZT is limited by its frequent toxicity, which sometimes relates to the amount of drug given. Thus, a combination treatment of two drugs that work together may provide more effective and safer treatment. IFN-A is a drug that has antiviral effects and may work well with AZT.

Conditions

HIV Infections

Keywords

Drug Therapy, Combination; AIDS-Related Complex; Zidovudine; Interferon Type I

Interventions

Interferon alfa-2a DRUG

Zidovudine DRUG

Eligibility Criteria

• Age: 3 Months - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Concurrent Medication:
• Recommended:
• Prophylaxis for Pneumocystis carinii pneumonia.
• Allowed:
• Aerosol ribavirin for short-term treatment of acute respiratory syncytial virus (RSV).
• Immunization according to the current recommendations of the Advisory Committee for Immunization Practice.
• IVIG. Systemic ketoconazole, acyclovir, or oral nystatin for acute therapy.
• Patients must have the following:
• HIV infection. Patients with proven resistance to AZT are also eligible.
• Prior Medication:
• Allowed:
• Aerosol ribavirin.
• Required:
• Cohort C treatment:
• Stable prescribed dose of zidovudine (AZT) \>= 90 mg/m2 for at least 6 weeks prior to study entry.

You may not qualify if:

• Co-existing Condition:
• Patients with the following conditions or symptoms are excluded: AIDS or class P-2B, D, or E symptomatic infection.
• Concurrent Medication:
• Excluded:
• Hepatotoxic or neurotoxic drugs, immunosuppressants, or antiseizure medication. Ketoconazole, fluconazole, and acyclovir for prophylaxis. Immunomodulators (other than IVIG). Experimental drugs.
• Cohort A patients:
• AZT for clinical indications.
• Prior Medication:
• Excluded:
• Other antiretroviral agents (including didanosine (ddI), dideoxycytidine (ddC), or soluble CD4) within 1 month of study entry. Systemic ribavirin administered for retroviral therapy within 2 months of study entry.
• Immunomodulating agents including interferon, isoprinosine, interleukin-2, or lymphocyte transfusions within 4 weeks of study entry.
• RBC transfusion within 4 weeks prior to study entry.
• Alcohol or drug abuse.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• Glaxo Wellcome: collaborator
• Hoffmann-La Roche: collaborator

Study Sites (9)

Cook County Hosp.

Chicago, Illinois, 60612, United States

Location

Chicago Children's CRS

Chicago, Illinois, 60614, United States

Location

Tulane/LSU Maternal/Child CRS

New Orleans, Louisiana, 70112, United States

Location

BMC, Div. of Ped Infectious Diseases

Boston, Massachusetts, 02118, United States

Location

NYU Med. Ctr., Dept. of Medicine

New York, New York, 10016, United States

Location

St. Jude/UTHSC CRS

Memphis, Tennessee, 38105, United States

Location

Univ. Hosp. Ramón Ruiz Arnau, Dept. of Peds.

Bayamón, Puerto Rico

Location

San Juan City Hosp. PR NICHD CRS

San Juan, 00936, Puerto Rico

Location

Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS

San Juan, 00936, Puerto Rico

Location

Related Publications (2)

• Diaz C, Yogev R, Culnane M, Rogers A, Van Dyke R, Fenton T. ACTG 153: a multicenter phase I study of alpha-interferon in HIV infected children. AIDS Clinical Trials Group. Int Conf AIDS. 1994 Aug 7-12;10(1):79 (abstract no 269B)

  BACKGROUND

• Clemente D, Yogev R, Culnane M, Rogers A, Van Dyke R, Hetherington S, Fenton T. ACTG 153: phase I, open-label; dose escalating study of interferon-alpha alone and in combination with zidovudine in children with early HIV disease. Program Abstr Intersci Conf Antimicrob Agents Chemother. 1994 Oct 4-7:35

  BACKGROUND

MeSH Terms

Conditions

HIV Infections; AIDS-Related Complex

Interventions

Interferon alpha-2; Zidovudine

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; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Interferon-alpha; Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Thymidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dideoxynucleosides; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Diaz C

  STUDY CHAIR

• Yogev R

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Study Completion: September 1, 1996
• Last Updated: October 29, 2021

Record last verified: 2021-10

Locations

PR (3); US (6)