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An Efficacy Study of 2',3'-Dideoxyinosine (ddI) (BMY-40900) Administered Orally Twice Daily to Zidovudine Intolerant Patients With AIDS or AIDS-Related Complex Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about An Efficacy Study of 2',3'-Dideoxyinosine (ddI) (BMY-40900) Administered Orally Twice Daily to Zidovudine Intolerant Patients With AIDS or AIDS-Related Complex conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. An Efficacy Study of 2',3'-Dideoxyinosine (ddI) (BMY-40900) Administered Orally Twice Daily to Zidovudine Intolerant Patients With AIDS or AIDS-Related Complex Clinical research trials and An Efficacy Study of 2',3'-Dideoxyinosine (ddI) (BMY-40900) Administered Orally Twice Daily to Zidovudine Intolerant Patients With AIDS or AIDS-Related Complex medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as An Efficacy Study of 2',3'-Dideoxyinosine (ddI) (BMY-40900) Administered Orally Twice Daily to Zidovudine Intolerant Patients With AIDS or AIDS-Related Complex. An Efficacy Study of 2',3'-Dideoxyinosine (ddI) (BMY-40900) Administered Orally Twice Daily to Zidovudine Intolerant Patients With AIDS or AIDS-Related Complex Clinical Trials and other clinical trials permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes there is a cost for a An Efficacy Study of 2',3'-Dideoxyinosine (ddI) (BMY-40900) Administered Orally Twice Daily to Zidovudine Intolerant Patients With AIDS or AIDS-Related Complex clinical trial. Subjects often receive the most expert healthcare possible for their An Efficacy Study of 2',3'-Dideoxyinosine (ddI) (BMY-40900) Administered Orally Twice Daily to Zidovudine Intolerant Patients With AIDS or AIDS-Related Complex condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > An Efficacy Study of 2',3'-Dideoxyinosine (ddI) (BMY-40900) Administered Orally Twice Daily to Zidovudine Intolerant Patients With AIDS or AIDS-Related Complex  An Efficacy Study of 2',3'-Dideoxyinosine (ddI) (BMY-40900) Administered Orally Twice Daily to Zidovudine Intolerant Patients With AIDS or AIDS-Related Complex
An Efficacy Study of 2',3'-Dideoxyinosine (ddI) (BMY-40900) Administered Orally Twice Daily to Zidovudine Intolerant Patients With AIDS or AIDS-Related Complex
For Condition: HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , Bristol-Myers Squibb
Synopsis: AMENDED: 8/29/90 Inclusion of asymptomatic patients with CD4 counts less than 200 cells/mm3. Standardization of baseline evaluation schedule to allow 14 days prior to study dosing. Reduction in frequency and intensity of follow-up evaluations. Standardization of study endpoints. Inclusion of toxicity scoring and management for amylase and triglyceride elevations. Clarification of concomitant medication use. Original design: To determine the effectiveness of didanosine (ddI) in patients with AIDS or advanced AIDS related complex (ARC) who have documented hematologic intolerance to zidovudine (AZT) therapy. To determine if the efficacy of ddI increases with increasing doses. AZT is effective in reducing mortality in patients with AIDS who receive the drug after the first episode of Pneumocystis carinii pneumonia (PCP) and in patients with advanced ARC. However, AZT therapy has been associated with significant toxicities. In addition, the effectiveness of AZT appears to decrease during the second and third years of therapy. For these reasons, the development of alternative therapy that would be at least as effective but less toxic is of great importance. The drug ddI is an antiviral agent that inhibits replication (reproduction) of HIV with less apparent toxicity than AZT. The major dose-limiting toxicities found in the Phase I studies have been pains in the feet and legs of 2 patients initially receiving 12 mg/kg/day and 12 patients receiving daily doses of 25.8 to 51.2 mg/kg; symptoms began 8 to 27 weeks after initiating ddI treatment. These neuropathy-like symptoms have generally not been associated with significant abnormalities in nerve conduction studies and patients have reported marked improvement in symptoms within 1 to 2 weeks of discontinuing ddI. Some patients have resumed ddI treatment at a reduced dose after resolution of their symptoms. Studies indicate that ddI remains active in the body for at least 12 hours. This indicates that benefits of ddI might be achieved with a low frequency of drug administration.
Details: AZT is effective in reducing mortality in patients with AIDS who receive the drug after the first episode of Pneumocystis carinii pneumonia (PCP) and in patients with advanced ARC. However, AZT therapy has been associated with significant toxicities. In addition, the effectiveness of AZT appears to decrease during the second and third years of therapy. For these reasons, the development of alternative therapy that would be at least as effective but less toxic is of great importance. The drug ddI is an antiviral agent that inhibits replication (reproduction) of HIV with less apparent toxicity than AZT. The major dose-limiting toxicities found in the Phase I studies have been pains in the feet and legs of 2 patients initially receiving 12 mg/kg/day and 12 patients receiving daily doses of 25.8 to 51.2 mg/kg; symptoms began 8 to 27 weeks after initiating ddI treatment. These neuropathy-like symptoms have generally not been associated with significant abnormalities in nerve conduction studies and patients have reported marked improvement in symptoms within 1 to 2 weeks of discontinuing ddI. Some patients have resumed ddI treatment at a reduced dose after resolution of their symptoms. Studies indicate that ddI remains active in the body for at least 12 hours. This indicates that benefits of ddI might be achieved with a low frequency of drug administration. Patients are randomized to one of three ddI treatment groups; within each group, doses will be adjusted according to patient's weight at study entry. Stratification is by diagnosis of AIDS or AIDS related complex (ARC) and Medical Center. Data will be tabulated for the Data and Safety Monitoring Board at 3 month intervals.
Eligibility:
Study Type: Interventional, Treatment, Dose Comparison
Minimum Age/Maximum Age: 12 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Required: - Aerosolized pentamidine (300 mg every 4 weeks). In the event of physiological intolerance, alternative PCP prophylaxis may be trimethoprim/sulfamethoxazole 1 DS tab per day or dapsone 50 - 100 mg per day. Allowed: - Chronic suppressive treatment for toxoplasmosis, Pneumocystis carinii pneumonia (PCP), cryptococcal meningitis, herpes simplex virus, cytomegalovirus, coccidioidomycosis, and histoplasmosis (absorption of ketoconazole or dapsone may be inhibited if given at the same time as the buffered solution of ddI, and should be taken 2 hours before or 2 hours after taking ddI; oral acidifying agents are not allowed). Isoniazid is permitted only if no acceptable alternative therapy is available. Metronidazole may be used for single courses not to exceed 14 days within consecutive 90 day intervals, the first of which begins at the initiation of the study. Erythropoietin for patients under the relevant treatment IND. Intravenous acyclovir for short courses of therapy. Patients must: - Have documented hematologic intolerance to zidovudine (AZT). - Have the diagnosis of AIDS or advanced AIDS related complex (ARC). - Have ended treatment for acute Pneumocystis carinii pneumonia (PCP) at least 2 weeks before study entry. Have previous intolerance on at least two courses of AZT therapy (one of which must have been at daily doses of 500 mg of AZT or less). - Be able to provide informed consent (and/or guardian as appropriate). - Be available for follow-up for at least 6 months. - Have baseline laboratory values as measured within 7 days before initial drug dosing. - Allowed: - Development of new opportunistic infections during the study - patients remain in the protocol. Prior Medication: Required: - Prior use and intolerance to zidovudine (AZT). - Allowed: - Intralesional agents. Exclusion Criteria Co-existing Condition: Patients with the following are excluded: - Presence of Kaposi's sarcoma (KS) with known or suspected visceral disease or where KS requires chemotherapy. - Active AIDS defining opportunistic infections not specifically allowed. - Intractable diarrhea. - Stage 2 AIDS-dementia complex. - History of intolerance to aerosolized pentamidine. - Grade 2 neuropathy, based on the Neuropathy Targeted Symptom Questionnaire, or any moderate abnormality indicative of peripheral neuropathy, particularly impaired sensation of sharp pain, light touch, or vibration in the lower extremities, distal extremity weakness, or distal extremity hyporeflexia. - Prior history of acute or chronic pancreatitis. - History of seizures within past 2 years or currently requiring anticonvulsants for control. - Any other clinical conditions or prior therapy which, in the opinion of the investigator, would make the patient unsuitable for study or unable to comply with the dosing requirements. Concurrent Medication: Excluded: - Isoniazid (INH). Patients with the following are excluded: - Active AIDS-defining opportunistic infections not specifically allowed. - Intractable diarrhea. - AIDS-dementia complex = or > stage 2. - History of intolerance to aerosolized pentamidine. Grade 2 neuropathy, based on the Neuropathy Targeted Symptom Questionnaire, or any moderate abnormality indicative of peripheral neuropathy, particularly impaired sensation of sharp pain, light touch, or vibration in the lower extremities, distal extremity weakness, or distal extremity hyporeflexia. - Prior history of acute or chronic pancreatitis. - History of seizures within past 2 years or currently requiring anticonvulsants for control. - Any other clinical conditions or prior therapy which, in the opinion of the investigator, would make the patient unsuitable for study or unable to comply with the dosing requirements. - Previous participation in any Phase I ddI study. - Life expectancy < 6 months. Prior Medication: Excluded: - Chronic therapy for cytomegalovirus infection with ganciclovir. - ddI. - d4T. - ddC. Excluded within 2 weeks of study entry: - Zidovudine (AZT). Excluded within 1 month of study entry: - Therapy with any other antiretroviral drug or investigational agent not specifically allowed, including interferon and immunomodulating drugs. - Ganciclovir. - Neurotoxic drugs. Excluded within 3 months of study entry: - Ribavirin. - Cytotoxic anticancer therapy. Prior Treatment: Excluded within 2 weeks of study randomization: - Transfusion. Active alcohol or drug abuse that is sufficient, in investigator's opinion, to prevent adequate compliance with study therapy.
Total Enrollment: 660
Location and Contact Information:
Overall Study Official:
JDAllan, Study Chair,
Cedars Sinai / UCLA Med Ctr
Los Angeles, California, 900481804
United States
SUNY - Stony Brook
Stony Brook, New York, 117948153
United States
Univ of South Florida
Tampa, Florida, 33612
United States
Louisiana Comprehensive Hemophilia Care Ctr
New Orleans, Louisiana, 70112
United States
Duke Univ Med Ctr
Durham, North Carolina, 27710
United States
Univ of Massachusetts Med Ctr
Worcester, Massachusetts, 01655
United States
Milton S Hershey Med Ctr
Hershey, Pennsylvania, 170330850
United States
Great Lakes Hemophilia Foundation
Milwaukee, Wisconsin, 53233
United States
Hemophilia Ctr of Western PA / Univ of Pittsburgh
Pittsburgh, Pennsylvania, 15219
United States
Stanford Univ School of Medicine
Stanford, California, 94305
United States
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033
United States
UCLA Med Ctr / Pediatric
Los Angeles, California, 900951752
United States
Ohio State Univ Hosp Clinic
Columbus, Ohio, 432101228
United States
Texas Children's Hosp / Baylor Univ
Houston, Texas, 77030
United States
Beth Israel Deaconess - West Campus
Boston, Massachusetts, 02215
United States
Univ of Kansas School of Medicine
Wichita, Kansas, 67214
United States
Beth Israel Deaconess Med Ctr
Boston, Massachusetts, 02215
United States
Mount Sinai Med Ctr
New York City, New York, 10029
United States
Palo Alto Veterans Adm Med Ctr / Stanford Univ
Palo Alto, California, 94304
United States
Univ of California / San Diego Treatment Ctr
San Diego, California, 921036325
United States
Johns Hopkins Hosp
Baltimore, Maryland, 21287
United States
Nebraska Regional Hemophilia Ctr
Omaha, Nebraska, 68105
United States
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, 14215
United States
Indiana Univ Hosp
Indianapolis, Indiana, 462025250
United States
Med Ctr of Central Massachusetts
Worcester, Massachusetts, 01605
United States
Univ of North Carolina
Chapel Hill, North Carolina, 275997215
United States
G E Morey Jr
Ft. Lauderdale, Florida, 33316
United States
Univ of Tennessee / E Tennessee Comprehensive Hemophilia Ctr
Knoxville, Tennessee, 37920
United States
Jack Weiler Hosp / Bronx Municipal Hosp
Bronx, New York, 10465
United States
Univ of Miami School of Medicine
Miami, Florida, 331361013
United States
Univ of Rochester Medical Center
Rochester, New York, 14642
United States
San Juan Veterans Administration Med Ctr
San Juan, , 009275800
Puerto Rico
City Hosp Ctr at Elmhurst / Mount Sinai Hosp
Elmhurst, New York, 11373
United States
Harvard (Massachusetts Gen Hosp)
Boston, Massachusetts, 02114
United States
Montefiore Med Ctr / Bronx Municipal Hosp
Bronx, New York, 10467
United States
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
George Washington Univ Med Ctr
Washington D.C., District of Columbia, 20037
United States
Univ of Pittsburgh Med School
Pittsburgh, Pennsylvania,
United States
Bowman Gray School of Medicine / Wake Forest Univ
Winston Salem, North Carolina, 27103
United States
Tulane Univ School of Medicine
New Orleans, Louisiana, 70112
United States
Hermann Hosp / Univ Texas Health Science Ctr
Houston, Texas, 77030
United States
Univ of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
Univ Hosp of Cleveland / Case Western Reserve Univ
Cleveland, Ohio, 44106
United States
Mountain States Regional Hemophilia Ctr / Univ of Colorado
Denver, Colorado, 80262
United States
Holmes Hosp / Univ of Cincinnati Med Ctr
Cincinnati, Ohio, 452670405
United States
Univ of Utah School of Medicine
Salt Lake City, Utah, 84132
United States
Beth Israel Med Ctr / Peter Krueger Clinic
New York City, New York, 10003
United States
Mount Sinai Hemophilia Ctr / Mount Sinai Med Ctr
New York City, New York, 10029
United States
Louisiana State Univ Med Ctr / Tulane Med School
New Orleans, Louisiana, 70112
United States
Sepulveda Veterans Adm Med Ctr / Olive View Med Ctr
Sylmar, California, 91342
United States
Harbor UCLA Med Ctr
Torrance, California, 90502
United States
Bronx Municipal Hosp Ctr/Jacobi Med Ctr
Bronx, New York, 10461
United States
Univ of Washington
Seattle, Washington, 98105
United States
Olive View Med Ctr
Sylmar, California, 91342
United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262
United States
Mem Sloan - Kettering Cancer Ctr
New York City, New York, 10021
United States
Northwestern Univ Med School
Chicago, Illinois, 60611
United States
SUNY / State Univ of New York
Syracuse, New York, 13210
United States
Edward Hines Veterans Administration Hosp
Hines, Illinois, 60141
United States
Julio Arroyo
West Columbia, South Carolina, 29169
United States
Saint Luke's - Roosevelt Hosp Ctr
New York City, New York, 10025
United States
Bronx Veterans Administration / Mount Sinai Hosp
Bronx, New York, 10468
United States
Baystate Med Ctr of Springfield
Springfield, Massachusetts, 01199
United States
Harbor - UCLA Med Ctr / UCLA School of Medicine
Los Angeles, California, 905022004
United States
Univ of Minnesota
Minneapolis, Minnesota, 55455
United States
Univ TX Galveston Med Branch
Galveston, Texas, 77550
United States
Boston Med Ctr
Boston, Massachusetts, 02118
United States
Additional Information:
Study ID Numbers: ACTG 118; 070V1,AI454-007
Study Start Date:
Record last reviewed: October 1994
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000672
Other Hiv Infections Studies:
1. Further Evaluation of Thalidomide's Ability to Potentiate the Immune Response to HIV-Infected Patients
2. Male Circumcision and HIV Rates in Kenya
3. The Effect of Oral Candidiasis on the Speech Production, Feeding Skills, and Self-Concept of Children and Adolescents with Symptomatic HIV Infection
4. A Study of Ritonavir/Indinavir Combination in HIV-Infected Patients
5. A Phase III Comparative Study of Dapsone / Trimethoprim and Clindamycin / Primaquine Versus Sulfamethoxazole / Trimethoprim in the Treatment of Mild-to-Moderate PCP in Patients With AIDS
Related Studies:
Other HIV Infections Clinical Trials
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Other Denver Clinical Trials
An Efficacy Study of 2',3'-Dideoxyinosine (ddI) (BMY-40900) Administered Orally Twice Daily to Zidovudine Intolerant Patients With AIDS or AIDS-Related Complex
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