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Comparison of ddI Versus Zidovudine in HIV-Infected Patients 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 Comparison of ddI Versus Zidovudine in HIV-Infected Patients conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Comparison of ddI Versus Zidovudine in HIV-Infected Patients Clinical research trials and Comparison of ddI Versus Zidovudine in HIV-Infected Patients 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 Comparison of ddI Versus Zidovudine in HIV-Infected Patients. Comparison of ddI Versus Zidovudine in HIV-Infected Patients 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 Comparison of ddI Versus Zidovudine in HIV-Infected Patients clinical trial. Human subjects often obtain the finest healthcare possible for their Comparison of ddI Versus Zidovudine in HIV-Infected Patients 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 > "C" Clinical Trials Conditions > Comparison of ddI Versus Zidovudine in HIV-Infected Patients  Comparison of ddI Versus Zidovudine in HIV-Infected Patients
Comparison of ddI Versus Zidovudine in HIV-Infected Patients
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, advanced AIDS-related complex (ARC), or asymptomatic infection with CD4 counts < 200 cells/mm3. 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.
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. AMENDED: 9/28/90 Patients are assigned to one of 2 treatments under a double-blind, randomly allocated, experimental design if their duration of prior AZT therapy is 0 to 16 weeks. (Patients who entered with no more than 16 weeks prior AZT and who were randomized to ddI will continue to be dosed at that level, adjusted for weight, and followed as originally planned.) Patients are assigned to one of 3 treatments as explained prior to this amendment if their duration of prior to AZT therapy is greater than 16 weeks. Original design: Patients are assigned to one of three treatments under a double-blind randomly allocated experimental design. ddI will be administered at two dose levels. It is anticipated that patients will be seen as outpatients every 2 weeks for the first 4 weeks of the study and monthly thereafter. This study continues for at least 18 months after the entry of the first subject.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 12 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Required: - Aerosolized pentamidine (300 mg every 4 weeks using a Respirgard II nebulizer). In the event of physiological intolerance, alternative prophylaxis may be: Trimethoprim / sulfamethoxazole 1 DS tab per day or dapsone 50 - 100 mg/day. Allowed: Maintenance therapy for active AIDS defining opportunistic infections for patients with 9 to 47 weeks' experience with zidovudine (AZT). Treatment of opportunistic infections with other than sulfonamide containing drugs: - Pyrimethamine and sulfadiazine or clindamycin for suppression of toxoplasmosis acquired after study entry; fluconazole or amphotericin B for suppression of cryptococcosis or ketoconazole for candidiasis. Intravenous acyclovir for up to 10 days. Erythropoietin for patients under the relevant treatment IND. Analgesics, antihistamines, antiemetics, antidiarrheal agents for symptomatic therapy for toxicities. Isoniazid (INH) if no other acceptable therapy is available. Metronidazole may be used for single courses of therapy not to exceed 14 days within consecutive 90 day intervals. Note: - Ketoconazole and dapsone should be taken 2 hours before or 2 hours after taking ddI (amendment 5/20/91). Concurrent Treatment: Allowed: - Blood transfusions for hemoglobin toxicity. Patients must: - Have a diagnosis of AIDS or advanced AIDS related complex (ARC), or per 8/09/90 amendment, asymptomatic HIV infection with CD4 count = or < 200 cells/mm3. - Be either naive to zidovudine (AZT) or have taken AZT for = or < 48 weeks. - Have ended treatment for acute Pneumocystis carinii pneumonia (PCP) at least 2 weeks before study entry. For patients with 2 months or less experience with AZT, PCP infection will be the single and only AIDS-defining infection and must have been within 120 days of study entry. Per amendment, other AIDS-defining conditions are allowed in the 8 weeks prior to study entry (for patients in the AZT stratum).Only one episode of PCP is permitted unless patient has > 2 months AZT experience in which case > 1 prior episode of PCP infection is allowed. - Not have experienced a major intolerance to AZT at doses of at least 500 mg if the patient was on AZT therapy for = or < 48 weeks. A major intolerance is defined as recurrent grade 3 or greater toxicity which results in discontinuation of drug. Allowed: - Basal cell carcinoma. - In situ carcinoma of the cervix. - Occasional premature atrial or ventricular contraction. - Patients developing new opportunistic infections after study entry will remain on this protocol. - Patients whose AIDS-defining condition is Kaposi's sarcoma alone must have CD4 cell counts < 300 cells/mm3. Prior Medication: Allowed: - Previous treatment with zidovudine (AZT) up to 48 weeks. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or diseases are excluded: - Kaposi's sarcoma (KS) with evidence of visceral disease or where KS requires chemotherapy; subjects with localized KS having CD4 counts = or > 200 cells/mm3. - AIDS-dementia complex = or > stage 2. - Prior history of acute pancreatitis within past 2 years or chronic pancreatitis. - Intractable diarrhea. - History of seizures within past 6 months or currently requiring anticonvulsants for control. - History of past or current heart disease. - Presence of a malignancy likely in the investigators opinion to require cytotoxic myelosuppressive chemotherapy during the expected course of this trial. Concurrent Medication: Excluded: - Oral acidifying agents. - Neurotoxic drugs. NOTE: If patients require therapy for PCP with IV pentamidine, study mediation is stopped. Patients with the following are excluded: - Active AIDS defining events. Maintenance therapy for prior AIDS-defining opportunistic infections is permitted. - Intolerance to AZT at doses of 500 mg because of recurrent grade 3 toxicity or greater which resulted in discontinuation of drug. - Neoplasms not specifically allowed. - Previous enrollment in any study of ddI, ddC or d4T. - > 48 weeks of AZT therapy. - An opportunistic infection not adequately controlled with suppressive therapies allowed in the protocol. - Psychological or emotional problems sufficient, in the investigator's opinion, to prevent adequate compliance study therapy. - Life expectancy = or < 6 months. Prior Medication: Excluded: - Ganciclovir. - AZT for = or > 48 weeks. Excluded within 14 days of study entry: - Erythropoietin (Eprex). Excluded within 30 days of study entry: - Anti-HIV therapy other than AZT. - Biologic response modifiers. - Other investigational drugs. - Corticosteroids. - Neurotoxic drugs. Excluded within 90 days of study entry: - Ribavirin. Prior Treatment: Excluded within 14 days of study entry: - Transfusion. Active alcohol or drug abuse sufficient, in the investigator's opinion, to prevent adequate compliance with study therapy.
Total Enrollment: 1500
Location and Contact Information:
Overall Study Official:
RDolin, Study Chair,
Nebraska Regional Hemophilia Ctr
Omaha, Nebraska, 68105
United States
Cook County Hosp
Chicago, Illinois, 60612
United States
Texas Children's Hosp / Baylor Univ
Houston, Texas, 77030
United States
Harbor UCLA Med Ctr
Torrance, California, 90502
United States
Univ of Massachusetts Med Ctr
Worcester, Massachusetts, 01655
United States
Olive View Med Ctr
Sylmar, California, 91342
United States
Hermann Hosp / Univ Texas Health Science Ctr
Houston, Texas, 77030
United States
Univ of Pittsburgh Med School
Pittsburgh, Pennsylvania,
United States
Stanford Univ School of Medicine
Stanford, California, 94305
United States
Louisiana Comprehensive Hemophilia Care Ctr
New Orleans, Louisiana, 70112
United States
Boston Med Ctr
Boston, Massachusetts, 02118
United States
Tulane Univ School of Medicine
New Orleans, Louisiana, 70112
United States
Univ of Tennessee / E Tennessee Comprehensive Hemophilia Ctr
Knoxville, Tennessee, 37920
United States
Mount Sinai Med Ctr
New York City, New York, 10029
United States
G E Morey Jr
Ft. Lauderdale, Florida, 33316
United States
Beth Israel Med Ctr / Peter Krueger Clinic
New York City, New York, 10003
United States
Duke Univ Med Ctr
Durham, North Carolina, 27710
United States
Northwestern Univ Med School
Chicago, Illinois, 60611
United States
Milton S Hershey Med Ctr
Hershey, Pennsylvania, 170330850
United States
Saint Luke's - Roosevelt Hosp Ctr
New York City, New York, 10025
United States
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033
United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262
United States
Jack Weiler Hosp / Bronx Municipal Hosp
Bronx, New York, 10465
United States
SUNY / State Univ of New York
Syracuse, New York, 13210
United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612
United States
Baystate Med Ctr of Springfield
Springfield, Massachusetts, 01199
United States
Univ of Utah School of Medicine
Salt Lake City, Utah, 84132
United States
Univ of California / San Diego Treatment Ctr
San Diego, California, 921036325
United States
Great Lakes Hemophilia Foundation
Milwaukee, Wisconsin, 53233
United States
Dr Brian Buggy
Milwaukee, Wisconsin, 53215
United States
George Washington Univ Med Ctr
Washington D.C., District of Columbia, 20037
United States
Louisiana State Univ Med Ctr / Tulane Med School
New Orleans, Louisiana, 70112
United States
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, 14215
United States
Bowman Gray School of Medicine / Wake Forest Univ
Winston Salem, North Carolina, 27103
United States
SUNY - Stony Brook
Stony Brook, New York, 117948153
United States
Hemophilia Ctr of Western PA / Univ of Pittsburgh
Pittsburgh, Pennsylvania, 15219
United States
Cornell Univ Med Ctr
New York City, New York, 10021
United States
Beth Israel Deaconess Med Ctr
Boston, Massachusetts, 02215
United States
Dr Stephen L Green
Hampton, Virginia, 23666
United States
Beth Israel Deaconess - West Campus
Boston, Massachusetts, 02215
United States
Univ of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
Palo Alto Veterans Adm Med Ctr / Stanford Univ
Palo Alto, California, 94304
United States
Bronx Veterans Administration / Mount Sinai Hosp
Bronx, New York, 10468
United States
Univ of Rochester Medical Center
Rochester, New York, 14642
United States
Charity Hosp / Tulane Univ Med School
New Orleans, Louisiana, 70112
United States
Med College of Ohio
Toledo, Ohio, 43699
United States
Univ of Kansas School of Medicine
Wichita, Kansas, 67214
United States
Milwaukee County Med Complex
Milwaukee, Wisconsin, 53226
United States
Univ of Miami School of Medicine
Miami, Florida, 331361013
United States
Mem Sloan - Kettering Cancer Ctr
New York City, New York, 10021
United States
Whitman - Walker Clinic
Washington D.C., District of Columbia, 20009
United States
Harvard (Massachusetts Gen Hosp)
Boston, Massachusetts, 02114
United States
Children's Hosp of Los Angeles/UCLA Med Ctr
Los Angeles, California, 900276016
United States
Univ of Minnesota
Minneapolis, Minnesota, 55455
United States
Univ TX Galveston Med Branch
Galveston, Texas, 77550
United States
Sepulveda Veterans Adm Med Ctr / Olive View Med Ctr
Sylmar, California, 91342
United States
Indiana Univ Hosp
Indianapolis, Indiana, 462025250
United States
Julio Arroyo
West Columbia, South Carolina, 29169
United States
Univ of Washington
Seattle, Washington, 98105
United States
Bronx Municipal Hosp Ctr/Jacobi Med Ctr
Bronx, New York, 10461
United States
Johns Hopkins Hosp
Baltimore, Maryland, 21287
United States
Montefiore Med Ctr / Bronx Municipal Hosp
Bronx, New York, 10467
United States
Ohio State Univ Hosp Clinic
Columbus, Ohio, 432101228
United States
Univ of North Carolina
Chapel Hill, North Carolina, 275997215
United States
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
San Juan Veterans Administration Med Ctr
San Juan, , 009275800
Puerto Rico
Mountain States Regional Hemophilia Ctr / Univ of Colorado
Denver, Colorado, 80262
United States
Med Ctr of Central Massachusetts
Worcester, Massachusetts, 01605
United States
Holmes Hosp / Univ of Cincinnati Med Ctr
Cincinnati, Ohio, 452670405
United States
Edward Hines Veterans Administration Hosp
Hines, Illinois, 60141
United States
City Hosp Ctr at Elmhurst / Mount Sinai Hosp
Elmhurst, New York, 11373
United States
Additional Information:
Study ID Numbers: ACTG 116; 070V1,ACTG 116-A,ACTG 116-B/117,AI454-008
Study Start Date:
Record last reviewed: January 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000979
Other Hiv Infections Studies:
1. The Safety and Effectiveness of FIAC in the Treatment of Cytomegalovirus (CMV) in Patients with AIDS
2. A Phase II Study of Low-Dose Interleukin-2 by Subcutaneous Injection in Combination With Antiretroviral Therapy Versus Antiretroviral Therapy Alone in Patients With HIV-1 Infection and at Least 3 Months Stable Antiretroviral Therapy
3. Study of How Indinavir (an Anti-HIV Drug) and Rifabutin (a Drug Used to Treat MAC, an HIV-Associated Disease) Interact in HIV-Positive and HIV-Negative Adults
4. An Open-Label Phase I/II Study of Recombinant Granulocyte Colony Stimulating Factor (r-metHuG-CSF) and Recombinant Erythropoietin (rHuEPO) Given Subcutaneously Along With Zidovudine (AZT) to Patients With the Acquired Immune Deficiency Syndrome (AIDS) or Severe AIDS-Related Complex (ARC)
5. The Safety and Effectiveness of 935U83 in HIV-Infected Patients
Related Studies:
Other HIV Infections Clinical Trials
Other North Carolina Clinical Trials
Other Winston Salem Clinical Trials
Comparison of ddI Versus Zidovudine in HIV-Infected Patients
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