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

CompletedPhase 1

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Conditions: HIV Infections

Interventions: Interferon alfa-2a, Zidovudine

Countries: United States, Puerto Rico

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.

Eligibility overview

Sex: ALL

Age: 3 Months to 17 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria

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.

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:

* 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.

Locations (9)

Chicago, Illinois, United States
Chicago, Illinois, United States
New Orleans, Louisiana, United States
Boston, Massachusetts, United States
New York, New York, United States
Memphis, Tennessee, United States
Bayamón, Puerto Rico
San Juan, Puerto Rico
San Juan, Puerto Rico