A Phase I Safety and Pharmacokinetics Study of 2',3'-Dideoxyinosine (ddI) Administered Twice Daily to Infants and Children With AIDS or Symptomatic HIV Infection

Completed · Phase 1

Conditions studied: HIV Infections

In brief

To determine the safety and maximum tolerated dose (MTD) of 2',3'-dideoxyinosine (ddI), given orally and intravenously, in infants and children with AIDS. The study also measures bloodstream and cerebrospinal fluid (CSF) levels of the administered drug, and provides a preliminary assessment of the effectiveness of ddI on HIV replication. AMENDED: Based on safety established in the first dosing phase of 52 weeks and long term dosing data in adults, the dosing period will be extended to 104 weeks. Original design: Information presently available indicates that ddI has high antiviral activity with less apparent toxicity than zidovudine (AZT) (the drug presently used to treat AIDS).

Key facts

Study ID

NCT00000669

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

25

Last updated by the study team

2008-08-26

Who can join

Age: 0 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Concurrent Medication:
• Allowed:
• Aerosolized pentamidine for Pneumocystis carinii pneumonia (PCP) prophylaxis if this drug is extended to children.
• Acute therapy not exceeding 7 days with oral or intravenous acyclovir for herpes simplex infections.
• Trimethoprim / sulfamethoxazole for Pneumocystis carinii infections during course of study at discretion of investigator after discussion with the sponsor.
• Symptomatic therapy with analgesics, antihistamines, antiemetics, antidiarrheal agents, or other supportive therapy as deemed necessary by the principal investigator.
• Patients must have:
• Diagnosis of AIDS as defined by CDC or meeting CDC P2 classification.
• Patients must be free of opportunistic infection or other serious bacterial, fungal, or parasitic infection at time of entry into study.
• Life expectancy > 6 months.
• Parent or guardian (and patient as applicable) able to give informed consent.
• Available for follow-up for at least 6 months.
• Allowed: Hemophilia.

You may not qualify if…

• Co-existing Condition:
• Children with the following are excluded:
• Chronic hematologic disorders unrelated to coagulation defects, hemoglobinopathies, or ITP.
• Intractable diarrhea.
• No venous access.
• History of seizures within previous 2 years or currently requiring anticonvulsants for control.
• Currently active heart disease as evidenced by a cardiac arrhythmia or other significant abnormality on routine electrocardiography (ECG) or shortening fraction of < 10 percent on echocardiogram.
• Renal disease.
• Any other clinical condition that in the opinion of the investigator makes the patient unsuitable for study.
• Concurrent Medication:
• Excluded:
• Antiretroviral drugs.
• Zidovudine (AZT).
• AL 721.
• Interferon.
• Corticosteroids.
• Immunomodulating drugs.
• Other systemic investigation agent.
• Ribavirin.
• Rifampin, barbiturates, or any other potent inducer or inhibitor of drug-metabolizing enzymes.
• Cytotoxic anticancer therapy.
• H-2 blockers.
• Intravenous ketoconazole.
• Immunoglobulin preparations.
• Children with the following are excluded:

Where it is running

• Univ of Alabama at Birmingham — Birmingham, Alabama, United States
• Univ of Miami School of Medicine — Miami, Florida, United States
• The Regional Medical Ctr, Memphis — Memphis, Tennessee, United States
• Baylor College of Medicine — Houston, Texas, United States
• Univ TX Health Science Ctr — Houston, Texas, United States

Full record on ClinicalTrials.gov

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