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A Phase I Safety, Efficacy, and Pharmacokinetic Study of 2',3'-Dideoxyinosine (ddI) Administered Twice Daily to Patients With AIDS or AIDS Related Complex Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on A Phase I Safety, Efficacy, and Pharmacokinetic Study of 2',3'-Dideoxyinosine (ddI) Administered Twice Daily to Patients With AIDS or AIDS Related Complex conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. A Phase I Safety, Efficacy, and Pharmacokinetic Study of 2',3'-Dideoxyinosine (ddI) Administered Twice Daily to Patients With AIDS or AIDS Related Complex Clinical research trials and A Phase I Safety, Efficacy, and Pharmacokinetic Study of 2',3'-Dideoxyinosine (ddI) Administered Twice Daily to Patients With AIDS or AIDS Related Complex medical trials happen in hundreds of localities 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 measure the effectualness of new does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like A Phase I Safety, Efficacy, and Pharmacokinetic Study of 2',3'-Dideoxyinosine (ddI) Administered Twice Daily to Patients With AIDS or AIDS Related Complex. A Phase I Safety, Efficacy, and Pharmacokinetic Study of 2',3'-Dideoxyinosine (ddI) Administered Twice Daily to Patients With AIDS or AIDS Related Complex Clinical Trials and other clinical trials permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes there is a cost for a A Phase I Safety, Efficacy, and Pharmacokinetic Study of 2',3'-Dideoxyinosine (ddI) Administered Twice Daily to Patients With AIDS or AIDS Related Complex clinical trial. Participants frequently obtain the most expert healthcare available for their A Phase I Safety, Efficacy, and Pharmacokinetic Study of 2',3'-Dideoxyinosine (ddI) Administered Twice Daily to Patients With AIDS or AIDS Related Complex condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > A Phase I Safety, Efficacy, and Pharmacokinetic Study of 2',3'-Dideoxyinosine (ddI) Administered Twice Daily to Patients With AIDS or AIDS Related Complex  A Phase I Safety, Efficacy, and Pharmacokinetic Study of 2',3'-Dideoxyinosine (ddI) Administered Twice Daily to Patients With AIDS or AIDS Related Complex
A Phase I Safety, Efficacy, and Pharmacokinetic Study of 2',3'-Dideoxyinosine (ddI) Administered Twice Daily to Patients With AIDS or AIDS Related Complex
For Condition: HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: To determine the safety, pharmacokinetics (blood levels), and effectiveness of didanosine (ddI) when administered both intravenously and orally. After the maximum tolerated dose (MTD) is determined, an appropriate dosage regimen will then be established for Phase II and Phase III trials. Zidovudine (AZT) has produced the best clinical results in the drug therapy of AIDS to date, but it produces toxicity in approximately 50 percent of patients. Early data show that ddI possesses high antiviral activity and less toxicity than AZT. The most effective route and dose of ddI has yet to be determined.
Details: Zidovudine (AZT) has produced the best clinical results in the drug therapy of AIDS to date, but it produces toxicity in approximately 50 percent of patients. Early data show that ddI possesses high antiviral activity and less toxicity than AZT. The most effective route and dose of ddI has yet to be determined. Patients are given intravenous drug for 14 days with a 1 day washout period, then 76 weeks of oral medication. To expedite this safety study and still be able to maintain close monitoring of the patient's health, an overlapping dosing regimen is used. After 6 patients have been enrolled and at least 4 have completed 4 weeks of dosing without significant toxic effects, a second group of patients is started at the next dose level. AMENDED: An alternative oral dosing formulation of ddI will be provided as a buffer powder blend packaged in sealed foil sachets in several strengths.
Eligibility:
Study Type: Interventional, Treatment, Open Label, Pharmacokinetics Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Recommended: - Allopurinol for consistent occurrence of hyperuricemia observed with 2',3'-dideoxyinosine (ddI) administration. Allowed: - Aerosolized pentamidine for Pneumocystis carinii pneumonia (PCP) prophylaxis. - Oral acyclovir for herpes simplex infections provided ddI dosing is suspended during this time. - Ketoconazole for patients not responding to any other therapy and after consultation with the sponsor. - Symptomatic therapy such as analgesics, antihistamines, antiemetics, antidiarrheal agents, or other supportive therapy may be administered as deemed necessary by the principal investigator. - Aspirin rather than acetaminophen for fever. Patients with the following will be included: - An absence of life-threatening opportunistic infection on enrollment. - A life expectancy less than 6 months. - Available for follow-up for at least 6 months. - Able to provide informed consent. Exclusion Criteria Co-existing Condition: Patients with the following are excluded: - Intractable diarrhea. - No venous access. - A history of or propensity for seizure disorders. - A history of past or current heart disease or other significant abnormality on routine EKG. Concurrent Medication: Excluded: - Adenine deaminase inhibitors. - Trimethoprim / sulfamethoxazole for Pneumocystis carinii pneumonia (PCP) infections. - Antibiotics. - Acetaminophen for therapy of fever. Patients with the following are excluded: - Intractable diarrhea. - A life expectancy less than 6 months. - No venous access. - A history of or propensity for seizure disorders. - A history of past or current heart disease or other significant abnormality on routine EKG. Prior Medication: Excluded: - Any agent known as a potent inducer or inhibitor of drug-metabolizing enzymes. - Excluded within 2 weeks of study entry: - Trimethoprim / sulfamethoxazole. - Excluded within 1 month of study entry: - Any antiretroviral drug. - Investigational agents. - 2',3'-didanosine. - AL721. - Interferons. - Immunomodulating drugs. - Excluded within 3 months of study entry: - Ribavirin. - Cytotoxic agents. Risk Behavior: Excluded: Active alcohol or drug abuse sufficient in the investigator's opinion to prevent adequate compliance.
Total Enrollment: 42
Location and Contact Information:
Overall Study Official:
DolinR, Study Chair,
Univ of Rochester Medical Center
Rochester, New York, 14642
United States
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, 14215
United States
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
Additional Information:
Study ID Numbers: ACTG 064;
Study Start Date:
Record last reviewed: February 1990
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000710
Other Hiv Infections Studies:
1. Daily Isoniazid to Prevent Tuberculosis in Infants Born to Mothers with HIV
2. An Open Label Phase I Study of Subcutaneously Administered Recombinant Human GM-CSF in Patients with AIDS Virus Infection and Leukopenia
3. A Study of WR 6026 in the Treatment of Pneumocystis carinii Pneumonia (PCP) in HIV-Infected Patients
4. A Phase I Study of the Safety and Pharmacokinetics of Recombinant Human CD4 Immunoglobulin (rCd4-IgG) Administered by Intravenous Bolus in Patients With AIDS and AIDS Related Complex
5. A Study of Fluconazole in the Treatment of Cryptococcal Meningitis in Patients Who Have Not Had Success with Amphotericin B
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A Phase I Safety, Efficacy, and Pharmacokinetic Study of 2',3'-Dideoxyinosine (ddI) Administered Twice Daily to Patients With AIDS or AIDS Related Complex
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