|
A Study Comparing Two Forms of Didanosine in HIV-infected Patients Clinical Trials References presented on Clinical Trials Search isn't meant to be a substitute for proven healthcare advice, trips or professional assistance using a genuine physician. We are not docs. Always confer with your physician about A Study Comparing Two Forms of Didanosine in HIV-infected Patients conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. A Study Comparing Two Forms of Didanosine in HIV-infected Patients Clinical research trials and A Study Comparing Two Forms of Didanosine in HIV-infected Patients healthcare trials happen in hundreds of localities 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 usually evaluate the potency of new drugs. The propose of the studies / projects is to answer particular human health questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to detect cures for all sorts of conditions, such as A Study Comparing Two Forms of Didanosine in HIV-infected Patients. A Study Comparing Two Forms of Didanosine in HIV-infected Patients Clinical Trials and other clinical trials allow volunteers to acquire healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a A Study Comparing Two Forms of Didanosine in HIV-infected Patients clinical trial. Subjects frequently obtain the most expert healthcare possible for their A Study Comparing Two Forms of Didanosine in HIV-infected Patients condition. Risks are a reality, nevertheless, and can include more or frequent doctor trips, medical risks (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with stern guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "A" Clinical Trials Conditions > A Study Comparing Two Forms of Didanosine in HIV-infected Patients  A Study Comparing Two Forms of Didanosine in HIV-infected Patients
A Study Comparing Two Forms of Didanosine in HIV-infected Patients
For Condition: HIV Infections
Status: No longer recruiting
Sponsor(s): Bristol-Myers Squibb ,
Synopsis: The purpose of this study is to see if the coated-capsule form of didanosine (ddI) is as safe and absorbed by the body as well as the chewable-tablet form of ddI. Didanosine (ddI) is an anti-HIV drug. The effectiveness of ddI can be lowered by acid in the stomach. To prevent this, patients take antacids with ddI. The coated-capsule form of ddI may replace the need for antacids.
Details: Didanosine, a purine nucleoside analogue, is indicated for the treatment of HIV infection when antiretroviral therapy is warranted. Didanosine is administered orally with antacids to protect it against acid-induced hydrolysis in the stomach. To eliminate the need for using buffers in the ddI formulations, an enteric-coated bead formulation of ddI is being developed. Patients are randomized to 1 of 2 groups to receive treatment on 2 separate occasions at least 72 hours apart. Group 1 receives the reference formulation of ddI. Group 2 receives the test formulation of ddI. Clinical evaluations, including clinical laboratory tests, are performed periodically during the study and at discharge. Serial blood samples are collected at specific time points over the 12 hours following dosing, and are used for the pharmacokinetic variables CMAX and AUC(INF). Factors used in analysis are sequence, subject within sequence, period, and formulation. Safety is assessed by monitoring adverse effects, vital signs, ECG recordings, and clinical laboratory tests throughout the study.
Eligibility:
Study Type: Interventional, Treatment, Crossover Assignment, Safety Study
Minimum Age/Maximum Age: 18 Years/50 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients must have: - HIV infection. - CD4 cell counts of at least 200 cells/mm3. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: - Any evidence of organ dysfunction. - Any clinically significant deviations from specified baseline requirements for physical examinations, laboratory tests, or 12-lead electrocardiogram.
Total Enrollment: 30
Location and Contact Information:
Overall Study Official:
CatherineKnupp, Study Director,
Additional Information:
Study ID Numbers: 039H; 31876,AI454-157
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002360
Other Hiv Infections Studies:
1. A Study of Efavirenz in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs
2. The Safety and Effectiveness of Indinavir Plus Ritonavir Plus Two NRTIs in HIV-Infected Patients Who Need Early Intervention Treatment
3. A Comparison of Nelfinavir Plus Saquinavir Plus Delavirdine or 3TC/ZDV Versus Nelfinavir Plus 3TC/ZDV in HIV-Infected Patients
4. A Study of Chlorhexidine in the Prevention of HIV-1 Transmission from Mothers to Their Babies
5. The Effect of Anti-HIV Treatment on Body Characteristics of HIV-Infected Children
Related Studies:
Other HIV Infections Clinical Trials
Other Clinical Trials
Other Clinical Trials
A Study Comparing Two Forms of Didanosine in HIV-infected Patients
|
|
|
|
|
|
|
|
