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A Phase II Efficacy Study Comparing 2',3'-Dideoxyinosine (ddI) (BMY-40900) and Zidovudine Therapy of Patients With HIV Infection Who Have Been on Long Term Zidovudine Treatment Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified medical advice, visits or professional assistance with a genuine dr.. We are not doctors. Always consult your mD about A Phase II Efficacy Study Comparing 2',3'-Dideoxyinosine (ddI) (BMY-40900) and Zidovudine Therapy of Patients With HIV Infection Who Have Been on Long Term Zidovudine Treatment conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. A Phase II Efficacy Study Comparing 2',3'-Dideoxyinosine (ddI) (BMY-40900) and Zidovudine Therapy of Patients With HIV Infection Who Have Been on Long Term Zidovudine Treatment Clinical research trials and A Phase II Efficacy Study Comparing 2',3'-Dideoxyinosine (ddI) (BMY-40900) and Zidovudine Therapy of Patients With HIV Infection Who Have Been on Long Term Zidovudine Treatment medical trials take place in many of places 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 usually evaluate the effectiveness of new does drugs. The purpose of the studies / projects is to solve specific human healthcare questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to find cures for all varieties of conditions, like A Phase II Efficacy Study Comparing 2',3'-Dideoxyinosine (ddI) (BMY-40900) and Zidovudine Therapy of Patients With HIV Infection Who Have Been on Long Term Zidovudine Treatment. A Phase II Efficacy Study Comparing 2',3'-Dideoxyinosine (ddI) (BMY-40900) and Zidovudine Therapy of Patients With HIV Infection Who Have Been on Long Term Zidovudine Treatment Clinical Trials and other clinical trials allow for volunteers to have health treatment options before they are available to the masses. Many times the human subjects acquire professional assistance for free of charge, and sometimes they are compensated for their time. Occasionally there is a cost for a A Phase II Efficacy Study Comparing 2',3'-Dideoxyinosine (ddI) (BMY-40900) and Zidovudine Therapy of Patients With HIV Infection Who Have Been on Long Term Zidovudine Treatment clinical trial. Test subjects typically obtain the finest healthcare available for their A Phase II Efficacy Study Comparing 2',3'-Dideoxyinosine (ddI) (BMY-40900) and Zidovudine Therapy of Patients With HIV Infection Who Have Been on Long Term Zidovudine Treatment condition. Dangers are a reality, nevertheless, and might include additional or frequent doctor trips, medical dangers (possibly life-jeopardising), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > A Phase II Efficacy Study Comparing 2',3'-Dideoxyinosine (ddI) (BMY-40900) and Zidovudine Therapy of Patients With HIV Infection Who Have Been on Long Term Zidovudine Treatment A Phase II Efficacy Study Comparing 2',3'-Dideoxyinosine (ddI) (BMY-40900) and Zidovudine Therapy of Patients With HIV Infection Who Have Been on Long Term Zidovudine Treatment
A Phase II Efficacy Study Comparing 2',3'-Dideoxyinosine (ddI) (BMY-40900) and Zidovudine Therapy of Patients With HIV Infection Who Have Been on Long Term Zidovudine Treatment
For Condition: HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , Bristol-Myers Squibb
Synopsis: To compare the effectiveness and toxicity of didanosine (ddI) and zidovudine (AZT) in patients with AIDS or advanced AIDS-related complex (ARC) who have tolerated AZT therapy for 12 months or longer. Per amendment, asymptomatic patients with CD4 counts less than 200 cells/mm3 are eligible. 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 of HIV with less apparent toxicity than AZT. Studies indicate that ddI remains active in the body for at least 12 hours; thus 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 of HIV with less apparent toxicity than AZT. Studies indicate that ddI remains active in the body for at least 12 hours; thus benefits of ddI might be achieved with a low frequency of drug administration. Two dose levels of ddI, each adjusted depending on patient's weight at study entry, are compared with a variable dosage regimen of AZT (the dose which the patient is tolerating at the time of study entry). Randomization is stratified by baseline CD4 cell count (less than 100 or 100-300) and Medical Center. This study continues for at least 12 months after the entry of the first subject. Patients randomized to AZT will receive orally. All patients randomized to AZT also receive a ddI placebo at 12 hour intervals. Patients randomized to ddI receive AZT placebo.
Eligibility:
Study Type: Interventional, Treatment, Double-Blind
Minimum Age/Maximum Age: 12 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Required: - Aerosolized pentamidine (300 mg every 4 weeks). Allowed: - Chronic suppressive treatment for toxoplasmosis, Pneumocystis carinii pneumonia (PCP), cryptococcal meningitis, herpes simplex virus infection. - Ganciclovir for patients developing cytomegalovirus (CMV) infection while in study. - Erythropoietin for patients under the relevant treatment IND. - Treatment of opportunistic infections with other than sulfonamide-containing regimens. - Aspirin, acetaminophen, or non-steroidal anti-inflammatory agents is discouraged, but is permitted for as short a period of time as possible. - Chronic use of trimethoprim - sulfamethoxazole or other sulfonamide preparations is not encouraged while on study. Patients must: - Have had the diagnosis of AIDS or advanced AIDS related complex (ARC). - Have received AZT therapy for at least 12 months, with a minimal daily dose of 500 mg/day and with no more than 60 days off AZT therapy within the 12 month period; medical records with documentation of AZT dosing must be provided. - Provide informed consent (guardian as appropriate). - Be available for follow-up for at least 6 months. - Have the inclusion laboratory values within approximately 14 days of initiating therapy (except for CD4 cell counts). - Patients whose AIDS-defining condition is Kaposi's sarcoma alone must have CD4 cell counts < 300 cells/mm3. Allowed: - Positive blood culture for Mycobacterium avium or Cytomegalovirus. - Prior history of toxoplasmosis, Herpes simplex, Cryptococcus, or Pneumocystis carinii pneumonia (PCP) requiring chronic suppressive therapy. - Occasional premature atrial or ventricular contractions. Prior Medication: Required: - Zidovudine (AZT) therapy for at least 12 months, with a minimal daily dose of 500 mg/day, and with no more than 60 days off AZT therapy within the 12-month period (documentation of AZT dosing must be provided). Allowed: - Intralesional agents. Exclusion Criteria Co-existing Condition: Patients with the following are excluded: - Psychological or emotional problems sufficient, in the investigator's opinion, to prevent adequate compliance with study therapy. - AIDS-dementia complex = or > stage 2. - Active AIDS defining opportunistic infections not specifically allowed. - Intractable diarrhea. - 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 hyperreflexia. - Prior history of acute pancreatitis within past 2 years or chronic pancreatitis. - History of seizures within past 2 years or currently requiring anticonvulsants for control. - History of past or current heart disease. - Malignancy likely in the investigator's opinion to require cytotoxic chemotherapy during the expected course of this trial. - Life expectancy < 3 months. Concurrent Medication: Excluded: - Isoniazid (INH). Neurotoxic drugs. Oral acidifying agents. Patients with the following are excluded: - Psychological or emotional problems sufficient, in the investigator's opinion, to prevent adequate compliance with study therapy. - AIDS-dementia complex = or > stage 2. - Active AIDS defining opportunistic infections not specifically allowed. - Intractable diarrhea. - Prior history of acute pancreatitis within past 2 years or chronic pancreatitis. - History of seizures within past 2 years or currently requiring anticonvulsants for control. - History of past or current heart disease. - Malignancy likely in the investigator's opinion to require cytotoxic chemotherapy during the expected course of this trial. - Life expectancy = or < 3 months. - Previous participation in any study of ddI, ddC or d4T. Prior Medication: Excluded: - Ganciclovir (DHPG). - Excluded within 1 month of study entry: - ddI and any other antiretroviral drug or investigational anti-HIV agent except for zidovudine (AZT). Interferons. - Immunomodulating drugs. - Cytotoxic agents not specifically allowed. - Neurotoxic drugs. Excluded within 3 months of study entry: - Ribavirin. Prior Treatment: Excluded within 14 days of study randomization: - Blood transfusion. Active alcohol or drug abuse that is sufficient, in investigator's opinion, to prevent adequate compliance with study therapy.
Total Enrollment: 750
Location and Contact Information:
Overall Study Official:
JKahn, Study Chair,
Med Ctr of Central Massachusetts
Worcester, Massachusetts, 01605
United States
Univ of Washington
Seattle, Washington, 98105
United States
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, 14215
United States
Univ of Pittsburgh Med School
Pittsburgh, Pennsylvania,
United States
Univ of Massachusetts Med Ctr
Worcester, Massachusetts, 01655
United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612
United States
Indiana Univ Hosp
Indianapolis, Indiana, 462025250
United States
Harbor UCLA Med Ctr
Torrance, California, 90502
United States
Montefiore Med Ctr / Bronx Municipal Hosp
Bronx, New York, 10467
United States
Univ of Tennessee / E Tennessee Comprehensive Hemophilia Ctr
Knoxville, Tennessee, 37920
United States
Univ of California / San Diego Treatment Ctr
San Diego, California, 921036325
United States
George Washington Univ Med Ctr
Washington D.C., District of Columbia, 20037
United States
Univ of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
Harbor - UCLA Med Ctr / UCLA School of Medicine
Los Angeles, California, 905022004
United States
Bowman Gray School of Medicine / Wake Forest Univ
Winston Salem, North Carolina, 27103
United States
Bronx Municipal Hosp Ctr/Jacobi Med Ctr
Bronx, New York, 10461
United States
Sepulveda Veterans Adm Med Ctr / Olive View Med Ctr
Sylmar, California, 91342
United States
Louisiana State Univ Med Ctr / Tulane Med School
New Orleans, Louisiana, 70112
United States
Mount Sinai Hemophilia Ctr / Mount Sinai Med Ctr
New York City, New York, 10029
United States
Beth Israel Med Ctr / Peter Krueger Clinic
New York City, New York, 10003
United States
Dr Brian Buggy
Milwaukee, Wisconsin, 53215
United States
Duke Univ Med Ctr
Durham, North Carolina, 27710
United States
Mem Sloan - Kettering Cancer Ctr
New York City, New York, 10021
United States
Beth Israel Deaconess - West Campus
Boston, Massachusetts, 02215
United States
SUNY / State Univ of New York
Syracuse, New York, 13210
United States
Hermann Hosp / Univ Texas Health Science Ctr
Houston, Texas, 77030
United States
Milton S Hershey Med Ctr
Hershey, Pennsylvania, 170330850
United States
Beth Israel Deaconess Med Ctr
Boston, Massachusetts, 02215
United States
Nebraska Regional Hemophilia Ctr
Omaha, Nebraska, 68105
United States
Dr Stephen L Green
Hampton, Virginia, 23666
United States
Saint Luke's - Roosevelt Hosp Ctr
New York City, New York, 10025
United States
Univ of Minnesota
Minneapolis, Minnesota, 55455
United States
San Juan Veterans Administration Med Ctr
San Juan, , 009275800
Puerto Rico
Jack Weiler Hosp / Bronx Municipal Hosp
Bronx, New York, 10465
United States
Univ of North Carolina
Chapel Hill, North Carolina, 275997215
United States
Ohio State Univ Hosp Clinic
Columbus, Ohio, 432101228
United States
Univ of Miami School of Medicine
Miami, Florida, 331361013
United States
Baystate Med Ctr of Springfield
Springfield, Massachusetts, 01199
United States
Northwestern Univ Med School
Chicago, Illinois, 60611
United States
Boston Med Ctr
Boston, Massachusetts, 02118
United States
Tulane Univ School of Medicine
New Orleans, Louisiana, 70112
United States
Harvard (Massachusetts Gen Hosp)
Boston, Massachusetts, 02114
United States
City Hosp Ctr at Elmhurst / Mount Sinai Hosp
Elmhurst, New York, 11373
United States
G E Morey Jr
Ft. Lauderdale, Florida, 33316
United States
Children's Hosp of Los Angeles/UCLA Med Ctr
Los Angeles, California, 900276016
United States
SUNY - Stony Brook
Stony Brook, New York, 117948153
United States
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
Cedars Sinai / UCLA Med Ctr
Los Angeles, California, 900481804
United States
Edward Hines Veterans Administration Hosp
Hines, Illinois, 60141
United States
Palo Alto Veterans Adm Med Ctr / Stanford Univ
Palo Alto, California, 94304
United States
Mountain States Regional Hemophilia Ctr / Univ of Colorado
Denver, Colorado, 80262
United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262
United States
Olive View Med Ctr
Sylmar, California, 91342
United States
Great Lakes Hemophilia Foundation
Milwaukee, Wisconsin, 53233
United States
Milwaukee County Med Complex
Milwaukee, Wisconsin, 53226
United States
Med College of Ohio
Toledo, Ohio, 43699
United States
Holmes Hosp / Univ of Cincinnati Med Ctr
Cincinnati, Ohio, 452670405
United States
Hemophilia Ctr of Western PA / Univ of Pittsburgh
Pittsburgh, Pennsylvania, 15219
United States
Univ of Kansas School of Medicine
Wichita, Kansas, 67214
United States
Bronx Veterans Administration / Mount Sinai Hosp
Bronx, New York, 10468
United States
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033
United States
Univ Hosp of Cleveland / Case Western Reserve Univ
Cleveland, Ohio, 44106
United States
Stanford at Kaiser / Kaiser Permanente Med Ctr
San Francisco, California, 94115
United States
San Francisco AIDS Clinic / San Francisco Gen Hosp
San Francisco, California, 941102859
United States
Mount Sinai Med Ctr
New York City, New York, 10029
United States
Univ of Rochester Medical Center
Rochester, New York, 14642
United States
Stanford Univ School of Medicine
Stanford, California, 94305
United States
Julio Arroyo
West Columbia, South Carolina, 29169
United States
UCLA CARE Ctr
Los Angeles, California, 90095
United States
Cornell Univ Med Ctr
New York City, New York, 10021
United States
Louisiana Comprehensive Hemophilia Care Ctr
New Orleans, Louisiana, 70112
United States
Additional Information:
Study ID Numbers: ACTG 117; 070V1,AI454-009
Study Start Date:
Record last reviewed: August 1992
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000671
Other Hiv Infections Studies:
1. A Comparison of Fluconazole and Amphotericin B in the Treatment of Cryptococcal Meningitis
2. Phase II/III Study of the Tolerance and Efficacy of Combined Use of Didanosine (2',3'-Dideoxyinosine; ddI) and Lentinan in HIV-Positive Patients
3. Evaluation of Amphotericin B in the Treatment of Biopsy Proven Candida Esophagitis in Immunocompromised Patients
4. Strategies for Delivering Anti-HIV Therapy in South Africa
5. Randomized, Controlled, Double-Blind Study of Itraconazole Oral Solution Versus Fluconazole Tablets for the Treatment of Esophageal Candidiasis.
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A Phase II Efficacy Study Comparing 2',3'-Dideoxyinosine (ddI) (BMY-40900) and Zidovudine Therapy of Patients With HIV Infection Who Have Been on Long Term Zidovudine Treatment
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