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Sponsors and Collaborators: |
Hoffmann-La Roche National Institute of Allergy and Infectious Diseases (NIAID) Glaxo Wellcome |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000967 |
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.
Condition | Intervention | Phase |
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HIV Infections |
Drug: Interferon alfa-2a Drug: Zidovudine |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Safety and Tolerance of Zidovudine and Interferon-Alpha in HIV-Infected Children |
Estimated Enrollment: | 52 |
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.
The study is being conducted in three stages. In Cohort A (IFN-A alone), four patients receive IFN-A; subsequent four-patient cohorts receive doses escalated in increments. If 50 percent or more of patients at any dose level experience grade 2 or better toxicity, doses in subsequent cohorts are escalated. If grade 3 or 4 toxicity is seen in one patient at a given dose level, two additional patients are enrolled at that level. Treatment is given subcutaneously (under the skin, with a needle), 3 times per week for 12 weeks. The MTD is defined as the dose level immediately below that at which 50 percent or more of patients experience grade 3 or 4 toxicity. In Cohort B (combination IFN-A plus AZT), patients who complete treatment in Cohort A continue on the same dose of IFN-A, and a low, middle, or high dose of AZT is added. In Cohort C, four newly assigned patients who have been on a stable prescribed dose of AZT of at least 90 mg/m2 for 6 weeks are treated at each of the same dose combinations as those in Cohort B. Treatment is given for 12 weeks. IFN-A is given subcutaneously 3 times a week and AZT is given orally every 6 hours. Dose levels of both drugs are increased until 50 percent or more of patients experience grade 3 or 4 toxicity in any dose level.
Ages Eligible for Study: | 3 Months to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Recommended:
Allowed:
Patients must have the following:
Prior Medication:
Allowed:
Required:
Cohort C treatment:
Exclusion Criteria
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:
Cohort A patients:
Prior Medication:
Excluded:
Alcohol or drug abuse.
United States, Illinois | |
Chicago Children's Memorial Hosp | |
Chicago, Illinois, United States, 606143394 | |
Cook County Hosp | |
Chicago, Illinois, United States, 60612 | |
United States, Louisiana | |
Tulane Univ / Charity Hosp of New Orleans | |
New Orleans, Louisiana, United States, 701122699 | |
United States, Massachusetts | |
Boston City Hosp / Pediatrics | |
Boston, Massachusetts, United States, 02118 | |
United States, New York | |
Bellevue Hosp / New York Univ Med Ctr | |
New York, New York, United States, 10016 | |
United States, Tennessee | |
Saint Jude Children's Research Hosp of Memphis | |
Memphis, Tennessee, United States, 381052794 | |
Puerto Rico | |
San Juan City Hosp | |
San Juan, Puerto Rico, 009367344 | |
UPR Children's Hosp / UPR School of Medicine | |
San Juan, Puerto Rico, 009365067 | |
Univ of Puerto Rico / Univ Children's Hosp AIDS | |
San Juan, Puerto Rico, 009365067 |
Study Chair: | Diaz C | |
Study Chair: | Yogev R |
Study ID Numbers: | ACTG 153 |
Study First Received: | November 2, 1999 |
Last Updated: | August 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00000967 |
Health Authority: | Unspecified |
Drug Therapy, Combination AIDS-Related Complex Zidovudine Interferon Type I |
Interferon-alpha Sexually Transmitted Diseases, Viral Interferon Type I, Recombinant Acquired Immunodeficiency Syndrome Interferons Zidovudine AIDS-Related Complex |
Immunologic Deficiency Syndromes Virus Diseases HIV Infections Sexually Transmitted Diseases Interferon Alfa-2a Retroviridae Infections |
Antimetabolites Anti-Infective Agents RNA Virus Infections Anti-HIV Agents Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Immune System Diseases Immunologic Factors Antineoplastic Agents Growth Substances Physiological Effects of Drugs Enzyme Inhibitors |
Infection Antiviral Agents Angiogenesis Inhibitors Pharmacologic Actions Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Lentivirus Infections Growth Inhibitors Angiogenesis Modulating Agents Nucleic Acid Synthesis Inhibitors |