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A Phase I Study of Combination Therapy With Didanosine (ddI) and Ribavirin in HIV-Infected Children. Clinical Trials Resources presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, visits or professional assistance with a real medical. We aren't doctors. Always consult your mD about A Phase I Study of Combination Therapy With Didanosine (ddI) and Ribavirin in HIV-Infected Children. conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. A Phase I Study of Combination Therapy With Didanosine (ddI) and Ribavirin in HIV-Infected Children. Clinical research trials and A Phase I Study of Combination Therapy With Didanosine (ddI) and Ribavirin in HIV-Infected Children. health trials occur in a lot of of places throughout the United States of America. 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 does drugs. The role of the studies / projects is to resolve certain human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector corporations to detect remedies for all varieties of circumstances, such as A Phase I Study of Combination Therapy With Didanosine (ddI) and Ribavirin in HIV-Infected Children.. A Phase I Study of Combination Therapy With Didanosine (ddI) and Ribavirin in HIV-Infected Children. Clinical Trials and other clinical trials allow volunteers to obtain health treatment choices before they are available to the general public. Most times the human subjects recieve professional assistance for free of charge, and every now and again they are paid for their time. Sometimes there is a cost for a A Phase I Study of Combination Therapy With Didanosine (ddI) and Ribavirin in HIV-Infected Children. clinical trial. Human subjects frequently get the finest healthcare available for their A Phase I Study of Combination Therapy With Didanosine (ddI) and Ribavirin in HIV-Infected Children. condition. Risks are a reality, however, and may include extra or frequent physician visits, medical dangers (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with strict guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > A Phase I Study of Combination Therapy With Didanosine (ddI) and Ribavirin in HIV-Infected Children.  A Phase I Study of Combination Therapy With Didanosine (ddI) and Ribavirin in HIV-Infected Children.
A Phase I Study of Combination Therapy With Didanosine (ddI) and Ribavirin in HIV-Infected Children.
For Condition: HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: To compare the safety, toxicity, and tolerance of two doses of ribavirin in combination with didanosine (ddI) to HIV-infected children. To determine the toxicity of ddI/ribavirin and compare it to the expected toxicity of ddI monotherapy. To determine the effect of concurrent ribavirin on the pharmacokinetics of ddI. To determine a dosage of ribavirin that would be suitable for a Phase II/III evaluation of ddI/ribavirin. Ribavirin, a broad spectrum antiviral agent, may enhance the antiretroviral activity of didanosine ( ddI ) without a concomitant increase in toxicity. Ribavirin alters the intracellular metabolism of ddI, enhancing the antiretroviral activity of the active form of ddI.
Details: Ribavirin, a broad spectrum antiviral agent, may enhance the antiretroviral activity of didanosine ( ddI ) without a concomitant increase in toxicity. Ribavirin alters the intracellular metabolism of ddI, enhancing the antiretroviral activity of the active form of ddI. Patients are divided into two cohorts. Subjects will be stratified by age 3 months to < 24 months and >= 24 months to 12 years. Fifty % of patients from each age group will be assigned to each cohort. Cohort 1 receives ddI monotherapy for 4 weeks, followed by combination ddl/ribavirin therapy for an additional 20 weeks. Cohort 2 receives combination ddI/ribavirin for 24 weeks. In both cohorts, after study medications are stopped, patients are treated with prescription antiretrovirals for 4 more weeks. [AS PER AMENDMENT 7/2/96: Note: In each cohort of 10 subjects at least 2 of 5 children from the older half of the cohort will have an ICD p24 antigen at entry.]
Eligibility:
Study Type: Interventional, Treatment, Dose Comparison, Safety Study
Minimum Age/Maximum Age: 3 Months/12 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Recommended: - PCP prophylaxis. Allowed: - Acetaminophen for no more than 72 hours. - Immunoglobulin. - Corticosteroids. - Erythropoietin. - G-CSF and GM-CSF. - Ethionamide or isoniazid for TB if no alternative available. - Immunizations according to current recommendations. Patients must have: - HIV infection. - Immunologic abnormality or clinical symptoms as detailed in the Disease Status field. - No active AIDS-defining opportunistic infection or malignancy, no progressive encephalopathy attributable to HIV and no chronic persistent diarrhea. - Consent of parent or guardian. PER AMENDMENT 7/2/96: - At least 2 of the 5 children in the older half of each cohort must have an ICD p24 antigen concentration >= 70 pg/ml at screening. Prior Medication: Allowed: - Up to 6 weeks of prior immunomodulator therapy. - Maternal immunomodulator or antiretroviral therapy, including during pregnancy. - Prior corticosteroids or intravenous immunoglobulin. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: - Current grade 3 or worse neuropathy/lower motor neuropathy. - Clinical or laboratory grade 3 or worse toxicities. - Active serious bacterial infection. Concurrent Medication: Excluded: - Chemotherapy for active malignancy. - Antiretrovirals other than study drugs. - Immunomodulators unless specifically allowed. Patients with the following prior condition are excluded: - History of grade 3 or worse neuropathy/lower motor neuropathy. Prior Medication: Excluded: - Prior ddI or oral ribavirin. - Aerosolized ribavirin within 6 weeks prior to study entry. - Antiretroviral or immunomodulator therapy (other than corticosteroids or IVIG) within 1 week prior to blood draws for study entry. Ongoing drug or alcohol abuse.
Total Enrollment: 20
Location and Contact Information:
Overall Study Official:
VanR, Study Chair,
Howard Univ Hosp
Washington D.C., District of Columbia, 20060
United States
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
Newark, New Jersey, 071032714
United States
Incarnation Children's Ctr / Columbia Presbyterian Med Ctr
New York City, New York, 10032
United States
Univ of Florida Health Science Ctr / Pediatrics
Jacksonville, Florida, 32209
United States
Children's Hosp of New Jersey / UMDNJ - New Jersey Med Schl
Newark, New Jersey, 071072198
United States
Tulane Univ / Charity Hosp of New Orleans
New Orleans, Louisiana, 701122699
United States
Harlem Hosp Ctr
New York City, New York, 10037
United States
Texas Children's Hosp / Baylor Univ
Houston, Texas, 77030
United States
Columbia Presbyterian Med Ctr
New York City, New York, 10032
United States
Glaxo Wellcome Inc
Research Triangle Park, North Carolina, 27709
United States
Children's Hosp of Boston
Boston, Massachusetts, 021155724
United States
Schneider Children's Hosp
New Hyde Park, New York, 11040
United States
Children's Hosp of Washington DC
Washington D.C., District of Columbia, 200102916
United States
Univ of Puerto Rico / Univ Children's Hosp AIDS
San Juan, , 009365067
Puerto Rico
Bronx Lebanon Hosp Ctr
Bronx, New York, 10457
United States
Additional Information:
Study ID Numbers: ACTG 274;
Study Start Date:
Record last reviewed: September 1997
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000833
Other Hiv Infections Studies:
1. Studies of Influenza Vaccine and Tetanus-Pneumococcal Vaccine in HIV-infected Patients Receiving Interleukin-2
2. A Study of Nevirapine for the Prevention of HIV Transmission from Mothers to Their Babies
3. A Study to Evaluate the Safety and Tolerance of Nelfinavir (NFV) Given with Zidovudine (ZDV) and Lamivudine (3TC) in HIV-Positive Pregnant Women and Their Infants
4. A Phase II, Stratified, Randomized, Double-Blind, Multi-Center Study of the Safety and Efficacy of Adefovir Dipivoxil (ADF) at Two Dose Levels in Triple Combination Therapies with Protease Inhibitors (PI) and Nucleoside Reverse Transcriptase Inhibitors (RTI) for the Treatment of HIV-Infected Patient
5. The Safety and Effectiveness of Pentamidine in the Prevention of Pneumocystis carinii Pneumonia (PCP) in Patients with AIDS Who Have Had PCP Before
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A Phase I Study of Combination Therapy With Didanosine (ddI) and Ribavirin in HIV-Infected Children.
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