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
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| ClinicalTrials.gov Identifier: NCT00000652 |
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Recruitment Status :
Completed
First Posted : August 31, 2001
Last Update Posted : November 1, 2012
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| HIV Infections | Drug: Zidovudine Drug: Didanosine | Phase 1 |
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.
Patients take AZT and ddI on an empty stomach; ddI is taken 2 minutes after taking antacid. Part A patients receive AZT plus ddI each at ranging doses. Patients in part B may receive a higher dose of ddI than patients in part A. The first patients enrolled are given the lowest dose. Subsequent patients receive increasingly higher doses until a dose limiting toxicity occurs.
| Study Type : | Interventional (Clinical Trial) |
| Enrollment : | 85 participants |
| Intervention Model: | Parallel Assignment |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Completion Date : | November 1995 |
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| Ages Eligible for Study: | 3 Months to 18 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000652
| United States, California | |
| Children's Hosp of Los Angeles/UCLA Med Ctr | |
| Los Angeles, California, United States, 900276016 | |
| Study Chair: | PA Pizzo | ||
| Study Chair: | RN Husson |
Publications:
| ClinicalTrials.gov Identifier: | NCT00000652 History of Changes |
| Other Study ID Numbers: |
ACTG 176 NCI 91 C-09 |
| First Posted: | August 31, 2001 Key Record Dates |
| Last Update Posted: | November 1, 2012 |
| Last Verified: | October 2012 |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
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Didanosine Drug Evaluation Drug Therapy, Combination Zidovudine |
Additional relevant MeSH terms:
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Infection Communicable Diseases HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |
Slow Virus Diseases Zidovudine Didanosine Antimetabolites Molecular Mechanisms of Pharmacological Action Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Anti-HIV Agents |