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A Clinical Trial of Alternating and Intermittent Regimens of 2',3'-Dideoxycytidine and 3'-Azido-3'-Deoxythymidine in the Treatment of Patients With AIDS and Advanced ARC 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 Clinical Trial of Alternating and Intermittent Regimens of 2',3'-Dideoxycytidine and 3'-Azido-3'-Deoxythymidine in the Treatment of Patients With AIDS and Advanced ARC conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. A Clinical Trial of Alternating and Intermittent Regimens of 2',3'-Dideoxycytidine and 3'-Azido-3'-Deoxythymidine in the Treatment of Patients With AIDS and Advanced ARC Clinical research trials and A Clinical Trial of Alternating and Intermittent Regimens of 2',3'-Dideoxycytidine and 3'-Azido-3'-Deoxythymidine in the Treatment of Patients With AIDS and Advanced ARC 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 Clinical Trial of Alternating and Intermittent Regimens of 2',3'-Dideoxycytidine and 3'-Azido-3'-Deoxythymidine in the Treatment of Patients With AIDS and Advanced ARC. A Clinical Trial of Alternating and Intermittent Regimens of 2',3'-Dideoxycytidine and 3'-Azido-3'-Deoxythymidine in the Treatment of Patients With AIDS and Advanced ARC 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 Clinical Trial of Alternating and Intermittent Regimens of 2',3'-Dideoxycytidine and 3'-Azido-3'-Deoxythymidine in the Treatment of Patients With AIDS and Advanced ARC clinical trial. Test subjects typically obtain the finest healthcare available for their A Clinical Trial of Alternating and Intermittent Regimens of 2',3'-Dideoxycytidine and 3'-Azido-3'-Deoxythymidine in the Treatment of Patients With AIDS and Advanced ARC 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 Clinical Trial of Alternating and Intermittent Regimens of 2',3'-Dideoxycytidine and 3'-Azido-3'-Deoxythymidine in the Treatment of Patients With AIDS and Advanced ARC  A Clinical Trial of Alternating and Intermittent Regimens of 2',3'-Dideoxycytidine and 3'-Azido-3'-Deoxythymidine in the Treatment of Patients With AIDS and Advanced ARC
A Clinical Trial of Alternating and Intermittent Regimens of 2',3'-Dideoxycytidine and 3'-Azido-3'-Deoxythymidine in the Treatment of Patients With AIDS and Advanced ARC
For Condition: HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , Hoffmann-La Roche
Synopsis: To determine if alternating zidovudine (AZT) and zalcitabine (dideoxycytidine; ddC) (first one and then the other) or intermittent therapy (1 week of drug then 1 week off) will lessen the toxic effects of either drug alone, while still inhibiting HIV (the AIDS virus) in patients with AIDS or AIDS related complex. AZT extends the survival of some patients with AIDS, and both AZT and ddC are known to inhibit the growth of HIV. When AZT or ddC is given continuously over a prolonged period of time, toxic effects occur that are not found when the drugs are given for 4 - 6 weeks. It is hoped that by alternating the drugs or by giving one drug intermittently, the toxic effects can be decreased without lowering the therapeutic effectiveness of the drugs.
Details: AZT extends the survival of some patients with AIDS, and both AZT and ddC are known to inhibit the growth of HIV. When AZT or ddC is given continuously over a prolonged period of time, toxic effects occur that are not found when the drugs are given for 4 - 6 weeks. It is hoped that by alternating the drugs or by giving one drug intermittently, the toxic effects can be decreased without lowering the therapeutic effectiveness of the drugs. Patients will be assigned to 1 of 7 treatment groups. Both AZT and ddC will be given by mouth every 4 hours. One group will take AZT continuously for 52 weeks. One group will alternate 1 week of AZT with a week with no drug for 48 weeks and another group will alternate 1 week of ddC with a week of no drug for 48 weeks. Other groups will alternate AZT and either low-dose or high-dose ddC on a weekly basis or a monthly basis for 48 weeks. Patients will be seen weekly for the first 8 weeks of study and less often thereafter. Blood samples will be withdrawn frequently and evaluated for possible changes in the immune system, toxic effects, and possible changes in the amount of HIV in the blood. Lumbar punctures and skin biopsies will also be performed. AMENDED: All patients receiving continuous AZT will be switched to a lower dose of AZT if they have not already been switched. This is in accordance with results of NIAID ACTG 002, 016, and 019 which demonstrate that this dose of AZT delays progression of HIV symptoms.
Eligibility:
Study Type: Interventional, Treatment, Open Label
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Encouraged though not required: - Inhaled pentamidine as prophylaxis for Pneumocystis carinii pneumonia (PCP). - Allowed: - AL-721 use is discouraged but not prohibited. - Use of aspirin, acetaminophen, and nonsteroidal anti-inflammatory agents should be minimized, with continuous use for > 72 hours discouraged. - Acute therapy (7 days) with oral acyclovir. - Acute therapy with ketoconazole. Concurrent Treatment: Allowed: - Up to 4 units of packed red blood cells for hemoglobin toxicity. All patients must have the following: - A consistently positive serum HIV p24 antigen = or > 70 pg/ml, defined by the Abbott HIV antigen test, on two occasions. The tests must be within 1 month of study entry, separated by at least 72 hours, and the last must be within 2 weeks of starting therapy. Any negative antigen test during the period will exclude the patient from the study. - A positive antibody to HIV confirmed by any federally licensed ELISA test kit. - Patients in group A must have AIDS related complex (ARC) as defined by the documented presence of at least one of the following: - Recurrent oral candidiasis. - Hairy leukoplakia. - History of herpes zoster. - Temperature > 38.5 degrees C with or without night sweats, persisting for > 14 consecutive days or > 15 days in a 30-day interval prior to study entry. - Weight loss of > 15 lbs. or 10 percent of body weight noted in a 120-day period prior to study entry. - Diarrhea defined as = or > 3 liquid stools per day, persisting for > 30 days prior to study entry without definable cause. - Patients in group B must have CDC-defined AIDS not requiring systemic maintenance chemotherapy. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: - Transfusion dependence requiring 2 units of blood more than once per month. - Significant malabsorption (> 10 percent weight loss within the past 3 months with serum carotene < 75 IU/ml or vitamin A < 74 IU/ml). - Significant cardiac or liver disease. - Significant neurologic abnormalities defined by any one of the following: - A significant abnormality on the ddC Neuropathy Targeted Symptom Questionnaire defined as a symptom score > 4 (moderate severity) in any one of six categories or a score > 2 (mild severity) in any two of six categories. - Moderate abnormalities on standardized neurologic exam. - Any severe abnormality (a value = or > 4.0) on standardized 4-arm quantitative sensory testing of vibration threshold. - Diabetes, renal failure, or alcoholism. - Dose-limiting or transfusion-requiring toxicity during a previous course of zidovudine therapy. - History of idiopathic thrombocytopenic purpura. - Requirement for prolonged acyclovir therapy. Patients in group A must not have the following: - Opportunistic infection or malignancy fulfilling the CDC definition of AIDS. - Neoplasms other than basal cell carcinoma of the skin or in situ carcinoma of the cervix. Patients in group B must not have the following: - Active opportunistic infection or AIDS-defining opportunistic infection requiring ongoing systemic therapy and/or prophylaxis other than inhaled pentamidine for Pneumocystis carinii pneumonia prophylaxis. - Symptomatic visceral Kaposi's sarcoma (KS), progression of KS within the month prior to study entry. - Concurrent neoplasms other than KS, basal cell carcinoma of the skin or in situ carcinoma of the cervix. Concurrent Medication: Excluded: - Neurotoxic drugs. - Prolonged acyclovir therapy. - Antineoplastic therapy. - Systemic therapy and/or prophylaxis for an AIDS-defining opportunistic infection, other than inhaled pentamidine for Pneumocystis carinii pneumonia (PCP) prophylaxis. - Other antiretroviral agents, immunomodulators, or systemic corticosteroids. - Other experimental medication. Concurrent Treatment: Excluded: - Transfusion dependency (requiring 2 units of blood more than once per month). Prior Medication: Excluded: - Antiretroviral agents within 60 days of study entry. - Biologic modifiers or corticosteroids within 30 days prior to study entry. - Dideoxycytidine (ddC). Prior Treatment: Excluded: - Blood transfusion within 2 weeks of entry. Any negative HIV p24 antigen test during the month prior to entry will exclude the patient from the study. Active drug or alcohol abuse.
Total Enrollment: 112
Location and Contact Information:
Overall Study Official:
GSkowron, Study Chair,
Harvard (Massachusetts Gen Hosp)
Boston, Massachusetts, 02114
United States
Saint Luke's - Roosevelt Hosp Ctr
New York City, New York, 10025
United States
Univ of Minnesota
Minneapolis, Minnesota, 55455
United States
Charity Hosp / Tulane Univ Med School
New Orleans, Louisiana, 70112
United States
George Washington Univ Med Ctr
Washington D.C., District of Columbia, 20037
United States
Northwestern Univ Med School
Chicago, Illinois, 60611
United States
Tulane Univ School of Medicine
New Orleans, Louisiana, 70112
United States
Univ of Miami School of Medicine
Miami, Florida, 331361013
United States
Univ of California / San Diego Treatment Ctr
San Diego, California, 921036325
United States
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033
United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612
United States
Julio Arroyo
West Columbia, South Carolina, 29169
United States
Louisiana State Univ Med Ctr / Tulane Med School
New Orleans, Louisiana, 70112
United States
Stanford Univ School of Medicine
Stanford, California, 94305
United States
Additional Information:
Study ID Numbers: ACTG 047;
Study Start Date:
Record last reviewed: August 1992
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000718
Other Hiv Infections Studies:
1. A Study of Two Adherence Plans to Help HIV-Positive Patients Take Their Medications Correctly
2. Rifabutin Therapy for the Prevention of Mycobacterium avium Complex (MAC) Bacteremia in HIV Positive Patients with CD4 Counts = or < 200: Treatment IND Study
3. A Comparison of Emtricitabine and Abacavir Used in a Three-Drug Combination in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs
4. Evaluating Immune Function Tests in People with HIV
5. An Open Parallel Study to Determine the Optimum Dosing Schedule for AS-101 in AIDS/ARC Patients
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A Clinical Trial of Alternating and Intermittent Regimens of 2',3'-Dideoxycytidine and 3'-Azido-3'-Deoxythymidine in the Treatment of Patients With AIDS and Advanced ARC
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