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A Treatment IND (Investigational New Drug) Protocol for the Use of Videx (2',3'-dideoxyinosine, ddI) in Patients With Acquired Immunodeficiency Syndrome (AIDS) or AIDS- Related Complex (ARC) Who Are Intolerant to Zidovudine (Retrovir) Clinical Trials Resources presented on Clinical Trials Search is not meant to be a substitute for proven health advice, calls or treatment with a real medical. We aren't mDs. Always consult your doctor on A Treatment IND (Investigational New Drug) Protocol for the Use of Videx (2',3'-dideoxyinosine, ddI) in Patients With Acquired Immunodeficiency Syndrome (AIDS) or AIDS- Related Complex (ARC) Who Are Intolerant to Zidovudine (Retrovir) conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. A Treatment IND (Investigational New Drug) Protocol for the Use of Videx (2',3'-dideoxyinosine, ddI) in Patients With Acquired Immunodeficiency Syndrome (AIDS) or AIDS- Related Complex (ARC) Who Are Intolerant to Zidovudine (Retrovir) Clinical research trials and A Treatment IND (Investigational New Drug) Protocol for the Use of Videx (2',3'-dideoxyinosine, ddI) in Patients With Acquired Immunodeficiency Syndrome (AIDS) or AIDS- Related Complex (ARC) Who Are Intolerant to Zidovudine (Retrovir) healthcare trials take place in a lot of of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectiveness of new does drugs. The function of the studies / projects is to figure out specific human medical questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to find cures for all varieties of conditions, like A Treatment IND (Investigational New Drug) Protocol for the Use of Videx (2',3'-dideoxyinosine, ddI) in Patients With Acquired Immunodeficiency Syndrome (AIDS) or AIDS- Related Complex (ARC) Who Are Intolerant to Zidovudine (Retrovir). A Treatment IND (Investigational New Drug) Protocol for the Use of Videx (2',3'-dideoxyinosine, ddI) in Patients With Acquired Immunodeficiency Syndrome (AIDS) or AIDS- Related Complex (ARC) Who Are Intolerant to Zidovudine (Retrovir) Clinical Trials and other clinical trials allow volunteers to access health treatment options before they are available to the masses. Many times the subjects receive professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a A Treatment IND (Investigational New Drug) Protocol for the Use of Videx (2',3'-dideoxyinosine, ddI) in Patients With Acquired Immunodeficiency Syndrome (AIDS) or AIDS- Related Complex (ARC) Who Are Intolerant to Zidovudine (Retrovir) clinical trial. Human subjects often obtain the finest healthcare possible for their A Treatment IND (Investigational New Drug) Protocol for the Use of Videx (2',3'-dideoxyinosine, ddI) in Patients With Acquired Immunodeficiency Syndrome (AIDS) or AIDS- Related Complex (ARC) Who Are Intolerant to Zidovudine (Retrovir) condition. Hazards are a reality, nevertheless, and might include additional or frequent dr. calls, health hazards (potentially life-jeopardizing), and/or the treatment being uneffective. Trials are federally regulated with stern guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > A Treatment IND (Investigational New Drug) Protocol for the Use of Videx (2',3'-dideoxyinosine, ddI) in Patients With Acquired Immunodeficiency Syndrome (AIDS) or AIDS- Related Complex (ARC) Who Are Intolerant to Zidovudine (Retrovir)  A Treatment IND (Investigational New Drug) Protocol for the Use of Videx (2',3'-dideoxyinosine, ddI) in Patients With Acquired Immunodeficiency Syndrome (AIDS) or AIDS- Related Complex (ARC) Who Are Intolerant to Zidovudine (Retrovir)
A Treatment IND (Investigational New Drug) Protocol for the Use of Videx (2',3'-dideoxyinosine, ddI) in Patients With Acquired Immunodeficiency Syndrome (AIDS) or AIDS- Related Complex (ARC) Who Are Intolerant to Zidovudine (Retrovir)
For Condition: HIV Infections
Status: No longer recruiting
Sponsor(s): Bristol-Myers Squibb ,
Synopsis: The objective of this treatment IND protocol is to make didanosine (ddI) available to patients with HIV infection (suffering from AIDS related complex (ARC) or AIDS) who have developed documented intolerance to zidovudine (AZT) and cannot enter a Phase II ddI program due to protocol exclusion or geographic location.
Details:
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 12 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: - Concomitant medications for the treatment of AIDS or ARC (including aerosolized pentamidine). - Phenytoin, but with caution. - Note: - Extreme caution should be exercised in the use of ddI in any patient receiving concomitant therapies, particularly those receiving other nucleosides (e.g. ganciclovir), drugs with toxicities similar to those observed with ddI (list included under concomitant medications section of protocol), and other drugs with significant toxicities, including many drugs used for treatment of major opportunistic infections. Patients must: Have a diagnosis of AIDS or be symptomatic, HIV positive, and have a CD4 cell count < 200 cells/mm3. Be intolerant to zidovudine (AZT) therapy. Not be suitable for study entry into the phase II didanosine (ddI) study by reason of inclusion or exclusion criteria or by reason of geographic location. Be able to provide signed informed consent (parent/guardian as appropriate). Be available for monthly follow-up while taking ddI. Meet baseline lab criteria within 14 days prior to initial drug dosing. Note: - Extreme caution should be exercised in the use of ddI in any patient receiving concomitant therapies, particularly those receiving other nucleosides (e.g., ganciclovir), drugs with toxicities similar to those observed with ddI (list included under concomitant medications section of protocol), and other drugs with significant toxicities, including many drugs used for treatment of major opportunistic infections. Caution should also be exercised in a patient having intractable diarrhea or patients following a low-sodium diet. Physicians caring for patients must perform clinical and laboratory evaluations every 7 - 10 days for the first 2 months of ddI therapy. All high-risk patients (for example, patients with preexisting disorders of body systems known to be adversely affected by ddI, particularly those with a history of peripheral neuropathy, pancreatitis, seizure disorder, cardiac abnormalities, gout, and significant elevations of liver function test results), must have clinical and laboratory evaluations performed every 10 days and results submitted to Bristol-Myers Squibb on the case report forms provided. Prior Medication: Allowed: - Anti-emetic medication. - Required: - Zidovudine (AZT). Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: - Malignancy likely to require chemotherapy in the first 3 months of ddI treatment. - Acute pancreatitis. - A poorly controlled seizure disorder. - Grade B or greater peripheral neuropathy. Concurrent Medication: Excluded: - Zidovudine (AZT). - Chemotherapy in the first 3 months of ddI treatment. Patients with the following are excluded: - Malignancy likely to require systemic chemotherapy in the first 3 months of ddI treatment. - Acute pancreatitis. - A poorly controlled seizure disorder. - Grade B or greater peripheral neuropathy. Prior Medication: Excluded within 15 days of study entry: - Any antiretroviral drug except zidovudine (AZT).
Total Enrollment:
Location and Contact Information:
Bristol - Myers Squibb Co
Princeton, New Jersey, 085434500
United States
Additional Information:
Study ID Numbers: 040A; 454-999-001
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002028
Other Hiv Infections Studies:
1. A Study of Isoprinosine in Patients with Severe AIDS
2. Therapeutic Vaccination Followed by Treatment Interruption in HIV Infected Patients
3. A Double-Blind Randomized Clinical Trial of a Rifabutin Regimen in the Treatment of Mycobacterium-avium Complex (MAC) Bacteremia in Patients With AIDS
4. A Pilot Study to Evaluate the Effects of Subcutaneously Administered Recombinant Human Granulocyte-Macrophage Colony Stimulating Factor in Pediatric HIV-Infected Patients With Neutropenia Secondary to Azidothymidine
5. Antibiotics to Reduce Chorioamnionitis-Related Perinatal HIV Transmission
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A Treatment IND (Investigational New Drug) Protocol for the Use of Videx (2',3'-dideoxyinosine, ddI) in Patients With Acquired Immunodeficiency Syndrome (AIDS) or AIDS- Related Complex (ARC) Who Are Intolerant to Zidovudine (Retrovir)
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