The Safety of Zidovudine Plus Interferon-Alpha in HIV-Infected Children
Completed · Phase 1
Conditions studied: HIV Infections
In brief
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.
Key facts
- Study ID
- NCT00000967
- Run by
- National Institute of Allergy and Infectious Diseases (NIAID)
- People needed
- 52
- Expected to finish
- 1996-09-01
- Last updated by the study team
- 2021-10-29
Who can join
Age: 0 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
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.
Where it is running
- Cook County Hosp. — Chicago, Illinois, United States
- Chicago Children's CRS — Chicago, Illinois, United States
- Tulane/LSU Maternal/Child CRS — New Orleans, Louisiana, United States
- BMC, Div. of Ped Infectious Diseases — Boston, Massachusetts, United States
- NYU Med. Ctr., Dept. of Medicine — New York, New York, United States
- St. Jude/UTHSC CRS — Memphis, Tennessee, United States
- Univ. Hosp. Ramón Ruiz Arnau, Dept. of Peds. — Bayamón, Puerto Rico
- San Juan City Hosp. PR NICHD CRS — San Juan, Puerto Rico
- Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS — San Juan, Puerto Rico
Full record on ClinicalTrials.gov
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