Pharmacokinetic evaluation of the combination of zidovudine and didanosine in children with human immunodeficiency virus infection.
B U Mueller, P A Pizzo, M Farley...
https://pubmed.ncbi.nlm.nih.gov/8021765Completed
Phase 1
Age: 3Months - 18Years
All Genders
ID00000652
A Phase I Study to Evaluate the Safety and Toxicity of the Combination of Zidovudine and 2',3'-Dideoxyinosine (Didanosine) in Children With HIV Infection
Led by National Cancer Institute (NCI) · Updated on 2012-11-01
85
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
To assess the safety and tolerance of the combination of zidovudine (AZT) and didanosine (ddI) in children with HIV infection. New approaches to using available agents may provide increased or improved treatment options for AIDS. Combination therapy is expected to play a major role in improving survival and quality of life for HIV-infected individuals. AZT and ddI are two agents that have been most extensively evaluated and for which the evidence for antiretroviral effectiveness is strongest.
CONDITIONS
Official Title
A Phase I Study to Evaluate the Safety and Toxicity of the Combination of Zidovudine and 2',3'-Dideoxyinosine (Didanosine) in Children With HIV Infection
Who Can Participate
Age: 3Months - 18Years
All Genders
Eligibility Criteria
You may qualify if you...
Inclusion Criteria
Concurrent Medication:
Allowed:
- Corticosteroids for treatment of lymphocytic interstitial pneumonitis.
Concurrent Treatment:
Allowed:
- Intravenous hyperalimentation.
Patients must have the following:
- P-2 class symptomatic HIV infection as defined by CDC OR who are asymptomatic but whose total CD4 cell count is < 500 cells/mm3.
- Freedom from significant active opportunistic or other infection requiring specific therapy.
Part B patients:
- Prior treatment with zidovudine (AZT) that was discontinued because of hematologic toxicity.
- Availability of a parent or legal guardian who is sufficiently reliable to give informed consent and follow necessary study procedures including administration of medications and return for follow-up visits.
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
- Critically ill, clinically unstable, or receiving drug therapy for an opportunistic or other infection.
- History of acute or chronic pancreatitis.
Patients with the following are excluded:
- Critically ill, clinically unstable, or receiving drug therapy for an opportunistic or other infection.
- History of acute or chronic pancreatitis.
Prior Medication:
Excluded:
- Antiretroviral or other antiviral agent within 14 days of entry into study.
- Immunomodulating agents, cytolytic chemotherapeutic agents, corticosteroids within 30 days (except for lymphocytic interstitial pneumonitis).
Part A patients:
- Zidovudine (AZT) or didanosine (ddI).
Part B patients:
- Didanosine (ddI).
Prior Treatment:
Excluded:
- Radiation therapy within 30 days.
- Intravenous immunoglobulin preparations within 14 days of entry into study.
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
Trial Site Locations
Total: 1 location
1
Children's Hosp of Los Angeles/UCLA Med Ctr
Los Angeles, California, United States, 900276016
Status Unknown
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
N/A
Allocation
N/A
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
0
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