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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 Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on 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 conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. 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 Clinical research trials and 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 health trials occur in hundreds of cities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including 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. 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 Clinical Trials and other clinical trials permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a 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 clinical trial. Participants oftentimes recieve the most expert healthcare available for their 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 condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > 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  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
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
For Condition: HIV Infections
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Parallel Assignment
Minimum Age/Maximum Age: 3 Months/18 Years
Genders: Both
Protocol Entry Criteria: 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.
Total Enrollment: 85
Location and Contact Information:
Overall Study Official:
PAPizzo, Study Chair,
Children's Hosp of Los Angeles/UCLA Med Ctr
Los Angeles, California, 900276016
United States
Additional Information:
Study ID Numbers: ACTG 176; NCI 91 C-09
Study Start Date:
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000652
Other Hiv Infections Studies:
1. A Study to Compare the Safety and Effectiveness of Two Dosing Schedules of Lamivudine in Combination with Two Other Anti-HIV Drugs
2. An Open Trial of Zidovudine (AZT) Treatment of the AIDS Dementia Complex in Patients With AIDS or Low CD4+ Lymphocyte Counts
3. A Six-Month Safety and Antiviral Study in HIV-1 Seropositive, AZT-Experienced Patients With CD4 Counts Less Than or Equal to 50 Cells/mm3 to Evaluate MK-639 Alone Versus Zidovudine (AZT) and 3TC Versus the Combination of MK-639 With AZT/3TC
4. A Study of Ribavirin in the Treatment of Patients with AIDS and AIDS-Related Problems
5. A Study of BMY-27857 in Patients with AIDS or AIDS Related Complex
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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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