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Double-Blind Comparison of the Efficacy of Continued Zidovudine versus 2',3'-Dideoxyinosine (ddI) (BMY-40900) for the Treatment of Patients With AIDS or AIDS-Related Complex and Increasing Symptomatology Despite Treatment with Zidovudine Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on Double-Blind Comparison of the Efficacy of Continued Zidovudine versus 2',3'-Dideoxyinosine (ddI) (BMY-40900) for the Treatment of Patients With AIDS or AIDS-Related Complex and Increasing Symptomatology Despite Treatment with Zidovudine conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Double-Blind Comparison of the Efficacy of Continued Zidovudine versus 2',3'-Dideoxyinosine (ddI) (BMY-40900) for the Treatment of Patients With AIDS or AIDS-Related Complex and Increasing Symptomatology Despite Treatment with Zidovudine Clinical research trials and Double-Blind Comparison of the Efficacy of Continued Zidovudine versus 2',3'-Dideoxyinosine (ddI) (BMY-40900) for the Treatment of Patients With AIDS or AIDS-Related Complex and Increasing Symptomatology Despite Treatment with Zidovudine healthcare trials take place in many of cities across 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 generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including Double-Blind Comparison of the Efficacy of Continued Zidovudine versus 2',3'-Dideoxyinosine (ddI) (BMY-40900) for the Treatment of Patients With AIDS or AIDS-Related Complex and Increasing Symptomatology Despite Treatment with Zidovudine. Double-Blind Comparison of the Efficacy of Continued Zidovudine versus 2',3'-Dideoxyinosine (ddI) (BMY-40900) for the Treatment of Patients With AIDS or AIDS-Related Complex and Increasing Symptomatology Despite Treatment with Zidovudine Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Double-Blind Comparison of the Efficacy of Continued Zidovudine versus 2',3'-Dideoxyinosine (ddI) (BMY-40900) for the Treatment of Patients With AIDS or AIDS-Related Complex and Increasing Symptomatology Despite Treatment with Zidovudine clinical trial. Test subjects oftentimes recieve the best healthcare possible for their Double-Blind Comparison of the Efficacy of Continued Zidovudine versus 2',3'-Dideoxyinosine (ddI) (BMY-40900) for the Treatment of Patients With AIDS or AIDS-Related Complex and Increasing Symptomatology Despite Treatment with Zidovudine condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "D" Clinical Trials Conditions > Double-Blind Comparison of the Efficacy of Continued Zidovudine versus 2',3'-Dideoxyinosine (ddI) (BMY-40900) for the Treatment of Patients With AIDS or AIDS-Related Complex and Increasing Symptomatology Despite Treatment with Zidovudine  Double-Blind Comparison of the Efficacy of Continued Zidovudine versus 2',3'-Dideoxyinosine (ddI) (BMY-40900) for the Treatment of Patients With AIDS or AIDS-Related Complex and Increasing Symptomatology Despite Treatment with Zidovudine
Double-Blind Comparison of the Efficacy of Continued Zidovudine versus 2',3'-Dideoxyinosine (ddI) (BMY-40900) for the Treatment of Patients With AIDS or AIDS-Related Complex and Increasing Symptomatology Despite Treatment with Zidovudine
For Condition: HIV Infections
Status: No longer recruiting
Sponsor(s): Bristol-Myers Squibb ,
Synopsis: To compare the efficacy and safety of orally administered didanosine (ddI) with orally administered zidovudine (AZT) in the treatment of patients who exhibit increasing clinical deterioration despite treatment with AZT.
Details:
Eligibility:
Study Type: Interventional, Treatment, Double-Blind, Safety Study
Minimum Age/Maximum Age: 12 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed for Hematologic toxicity: - Erythropoietin. - Colony-Stimulating Factors. - Allowed for prophylaxis of Pneumocystis carinii pneumonia (PCP): - Aerosolized pentamidine. - Trimethoprim/sulfamethoxazole. - Dapsone. - NOTE: - If intravenous pentamidine is required for treatment of PCP, study drug should be suspended until one week after completion of intravenous pentamidine. - Allowed: - Prophylactic or suppressive therapy begun prior to study entry with the exception of neurotoxic agents (as defined in the protocol). Concurrent Treatment: Allowed: - Transfusions for hematologic toxicity. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: - Active acute AIDS defining infection. - Clinical evidence of acute pancreatitis in the last two years or chronic pancreatitis. - Dementia of such severity that patient cannot give informed consent. - Grade 2 or worse peripheral neuropathy as defined by Targeted Neuropathy Score (Schaumberg). - Prior Cytomegalovirus disease requiring ongoing systemic ganciclovir therapy. - Extensive Kaposi's sarcoma or other malignancy requiring systemic cytotoxic myelosuppressive or neurotoxic chemotherapy. - Cardiomyopathy or the need for antiarrhythmic therapy. - Inability to tolerate at least 600 mg per day of zidovudine (AZT). - Seizures within the last 6 months or the need for anticonvulsant therapy. Concurrent Medication: Excluded: - Ganciclovir (DHPG). - Myelosuppressive or neurotoxic chemotherapy. - Antiarrhythmic therapy. - Anticonvulsant therapy. - Neurotoxic agents (as defined in the protocol). - NOTE: - If intravenous pentamidine is required for treatment of Pneumocystis carinii pneumonia (PCP), study drug should be suspended until 1 week after completion of intravenous pentamidine. Patients with the following are excluded: - Symptoms and conditions defined in the Patient Exclusion Co-Existing Conditions field. - Average of two sequential CD4 counts from SciCor Clinical Laboratories in the 30 days prior to study entry > 300 cells/mm3. Prior Medication: Excluded, participation in studies using: - Dideoxyinosine (ddI). - 2',3'-Dideoxy-2',3'-didehydrothymidine (d4T). - Dideoxycytidine (ddC). - Excluded within one month of study entry: - Any other experimental antiretroviral compounds. Patients must: - Have documented HIV positivity via ELISA. - Meet CDC criteria for AIDS or AIDS related complex (ARC). - Have received zidovudine (AZT) for = or > 6 months and tolerated a dose of at least 500 mg per day without significant hematologic toxicity. - Have no acute AIDS defining opportunistic infection, but may be receiving suppressive therapy for such infections. - Demonstrate at least one of the following criteria for clinical deterioration despite AZT therapy within 4 weeks prior to study entry (8 weeks prior for weight loss): - involuntary weight loss of more than 5 percent of the body weight occurring over the 8 week period prior to study entry, Karnofsky score = or > 50 but demonstrating a fall = or > 20 from previous level of functioning (assessment must be persistent on two occasions at least 14 days apart), unexplained fever of = or > 38 degrees C (despite evaluation defined in protocol) for more than 7 days, appearance of newly diagnosed oral hairy leukoplakia or oral candidiasis, or recurrence of a previously quiescent multidermatomal varicella-zoster, appearance of dermatologic afflictions (e.g. psoriasis, molluscum contagiosum, or newly diagnosed seborrheic dermatitis), appearance of chronic herpetic ulcers not responsive to acyclovir therapy. Required: - Zidovudine (AZT) for = or > 6 months prior to study entry.
Total Enrollment: 300
Location and Contact Information:
Univ of Utah School of Medicine
Salt Lake City, Utah, 84132
United States
Yale Univ Med School
New Haven, Connecticut, 06510
United States
Univ of Arizona / Health Science Ctr
Tucson, Arizona, 85724
United States
Dr Stephen L Green
Hampton, Virginia, 23666
United States
Med College of Ohio
Toledo, Ohio, 43699
United States
Edward Hines Veterans Administration Hosp
Hines, Illinois, 60141
United States
Audie L Murphy Veterans Administration Hosp
San Antonio, Texas, 78284
United States
G E Morey Jr
Ft. Lauderdale, Florida, 33316
United States
Univ of Kansas School of Medicine
Wichita, Kansas, 67214
United States
Albany Med College / AIDS Treatment Ctr
Albany, New York, 12203
United States
Milwaukee County Med Complex
Milwaukee, Wisconsin, 53226
United States
Univ of Pennsylvania / HIV Clinic
Philadelphia, Pennsylvania, 19104
United States
Harper Hosp
Detroit, Michigan, 48201
United States
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 30308
United States
Univ TX Galveston Med Branch
Galveston, Texas, 775550882
United States
VP Med Services / HHCS Research Institute Inc
Orlando, Florida, 32806
United States
UPR School of Medicine
San Juan, , 009275800
Puerto Rico
Univ of Texas Southwestern Med Ctr of Dallas
Dallas, Texas, 75235
United States
Additional Information:
Study ID Numbers: 039B; AI454-010
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002035
Other Hiv Infections Studies:
1. A Prospective, Randomized, Open-Label, Comparative Trial of Dideoxyinosine (ddI) Versus Dideoxycytidine (ddC) in HIV-Infected Patients Who Are Intolerant of or Who Have Failed Zidovudine (AZT) Therapy
2. Double-Blind Comparison of the Efficacy of Continued Zidovudine versus 2',3'-Dideoxyinosine (ddI) (BMY-40900) for the Treatment of Patients With AIDS or AIDS-Related Complex and Increasing Symptomatology Despite Treatment with Zidovudine
3. Pneumococcal Vaccine and Routine Pediatric Immunizations in HIV-Infected Children Receiving Anti-HIV Drugs
4. A Study of the Long-Term Outcomes of HIV-Positive Patients
5. Atazanavir Used in Combination with Other Anti-HIV Drugs in HIV-Infected Infants, Children, and Adolescents
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Double-Blind Comparison of the Efficacy of Continued Zidovudine versus 2',3'-Dideoxyinosine (ddI) (BMY-40900) for the Treatment of Patients With AIDS or AIDS-Related Complex and Increasing Symptomatology Despite Treatment with Zidovudine
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