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(Ro 24-2027) A Randomized, Double-Blind, Comparative Study of Dideoxycytidine (ddC) versus Zidovudine (AZT) in Patients With AIDS or Advanced ARC Clinical Trials Resources presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, visits or professional assistance with a real medical. We aren't doctors. Always consult your mD about (Ro 24-2027) A Randomized, Double-Blind, Comparative Study of Dideoxycytidine (ddC) versus Zidovudine (AZT) in Patients With AIDS or Advanced ARC conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. (Ro 24-2027) A Randomized, Double-Blind, Comparative Study of Dideoxycytidine (ddC) versus Zidovudine (AZT) in Patients With AIDS or Advanced ARC Clinical research trials and (Ro 24-2027) A Randomized, Double-Blind, Comparative Study of Dideoxycytidine (ddC) versus Zidovudine (AZT) in Patients With AIDS or Advanced ARC health trials occur in a lot of of places throughout 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 typically assess the effectivity of new does drugs. The role of the studies / projects is to resolve certain human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector corporations to detect remedies for all varieties of circumstances, such as (Ro 24-2027) A Randomized, Double-Blind, Comparative Study of Dideoxycytidine (ddC) versus Zidovudine (AZT) in Patients With AIDS or Advanced ARC. (Ro 24-2027) A Randomized, Double-Blind, Comparative Study of Dideoxycytidine (ddC) versus Zidovudine (AZT) in Patients With AIDS or Advanced ARC Clinical Trials and other clinical trials allow volunteers to obtain health treatment choices before they are available to the general public. Most times the human subjects recieve professional assistance for free of charge, and every now and again they are paid for their time. Sometimes there is a cost for a (Ro 24-2027) A Randomized, Double-Blind, Comparative Study of Dideoxycytidine (ddC) versus Zidovudine (AZT) in Patients With AIDS or Advanced ARC clinical trial. Human subjects frequently get the finest healthcare available for their (Ro 24-2027) A Randomized, Double-Blind, Comparative Study of Dideoxycytidine (ddC) versus Zidovudine (AZT) in Patients With AIDS or Advanced ARC condition. Risks are a reality, however, and may include extra or frequent physician visits, medical dangers (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with strict guidelines to protect clinical trials patients.
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Home > "(" Clinical Trials Conditions > (Ro 24-2027) A Randomized, Double-Blind, Comparative Study of Dideoxycytidine (ddC) versus Zidovudine (AZT) in Patients With AIDS or Advanced ARC  (Ro 24-2027) A Randomized, Double-Blind, Comparative Study of Dideoxycytidine (ddC) versus Zidovudine (AZT) in Patients With AIDS or Advanced ARC
(Ro 24-2027) A Randomized, Double-Blind, Comparative Study of Dideoxycytidine (ddC) versus Zidovudine (AZT) in Patients With AIDS or Advanced ARC
For Condition: HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , Hoffmann-La Roche
Synopsis: To show that zalcitabine (dideoxycytidine; ddC) is at least as effective as zidovudine (AZT) in the treatment of AIDS or advanced AIDS related complex (ARC), and also that ddC shows a different safety profile than AZT. In clinical studies, ddC shows antiviral activity. Because of the antiviral activity, and because of the low incidence of mild, reversible neurotoxicity and absence of blood-related toxicity with low dose ddC therapy, a long-term Phase II/III study comparing ddC to AZT in patients with AIDS or advanced ARC is now warranted.
Details: In clinical studies, ddC shows antiviral activity. Because of the antiviral activity, and because of the low incidence of mild, reversible neurotoxicity and absence of blood-related toxicity with low dose ddC therapy, a long-term Phase II/III study comparing ddC to AZT in patients with AIDS or advanced ARC is now warranted. After screening, physical examination and laboratory tests (within 14 days of entry) patients are randomized to one of two treatment groups. They receive either ddC plus an AZT placebo or AZT plus a ddC placebo. Because it is a blinded study, patients do not know which group they are in. Patients are evaluated weekly for the first 10 weeks and then biweekly thereafter.
Eligibility:
Study Type: Interventional, Treatment, Double-Blind
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: - Aerosolized pentamidine (300 mg once every 4 weeks) for Pneumocystis carinii pneumonia (PCP) prophylaxis. - Neuroleptics, benzodiazepines, or antidepressants if patient has been stable with chronic treatment > 1 month. - Low dose benzodiazepines or low dose antidepressants. - Drugs that are unlikely to cause increased toxicity with either study drug and are unlikely to cause peripheral neuropathy. - Drugs with little nephrotoxicity, hepatotoxicity, or cytotoxicity that the patient has been taking and tolerating well. - Acyclovir (up to 600 mg/kg/day) for up to 21 days. - Ketoconazole (up to 400 mg/day) Nystatin. - Low-dose acetaminophen or nonsteroidal anti-inflammatory agents. - Isoniazid if patient has no evidence of peripheral neuropathy at entry and if patient takes 50 mg/day pyridoxine concomitantly with isoniazid. - Allowed with interruption of study medication for up to 21 days per episode and for a total of 42 days for the study: - Drugs that could cause serious additive toxicity when coadministered with either study medication for treatment of an acute intercurrent illness or opportunistic infection, including: - Acyclovir (< 600 mg/day), fluconazole, systemic pentamidine, foscarnet, pyrimethamine, triple sulfa, ansamycin, ganciclovir, trimethoprim / sulfamethoxazole. Patients must have a diagnosis of AIDS or advanced AIDS related complex (ARC). At least 20 percent of the patients must have a consistently positive serum HIV p24 antigen (= or > 70 pg/ml) as defined by the Abbott HIV antigen test, on two separate occasions at least 72 hours apart. - Patients found at screening to have a temperature > 38.5 degrees C should be evaluated for the possibility of an occult opportunistic or bacterial infection or neoplasm. If this complete evaluation reveals an infection, they can be entered. If this evaluation is unrevealing, they may be entered after evaluation is completed but while mycobacterial cultures are still pending. Patients with a history of unexplained temperatures > 38.5 degrees C should be evaluated as above and/or be afebrile (temperature < 38.0 degrees C) for 2 weeks prior to study entry. - Allowed: Kaposi's sarcoma not specifically excluded, basal cell carcinoma of the skin or in situ carcinoma of the cervix. - Current positive venereal disease research label (VDRL) and fluorescent treponemal antibody (FTA) if treated as for asymptomatic neurosyphilis. Prior Medication: Allowed: - Drugs that cause peripheral neuropathy and drugs that could cause significant increased toxicity with zidovudine (AZT) or dideoxycytidine (ddC) including experimental drugs if therapy with these drugs is completed and patient is stable for 14 days. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: - Active AIDS defining opportunistic infection or other active intercurrent illness is excluded if ongoing treatment requires the use of excluded concomitant medication. - Patients with symptomatic visceral Kaposi's sarcoma (KS), progression of KS within the month prior to entry into the study, or with current neoplasms not specifically allowed. - Severe AIDS dementia complex defined by a score of < 23 on the Mini-Mental State Exam. - Signs, symptoms, or history of peripheral neuropathy. - Significant cardiac disease, defined as history of ventricular arrhythmias requiring medication, prior myocardial infarct, or history of angina or ischemia changes on ECG (electrocardiography). - Requiring > 2 weeks of acyclovir therapy at > 600 mg/day. - Current positive venereal disease research label (VDRL) and fluorescent treponemal antibody (FTA) not specifically allowed. - Significant liver disease. Concurrent Medication: Excluded: - Drugs that cause peripheral neuropathy: - chloramphenicol, cisplatinum, iodoquinol, dapsone, phenytoin, disulfiram, ethionamide, glutethimide, gold, hydralazine, ribavirin, metronidazole, vincristine, nitrofurantoin. - Drugs that could cause significant increased toxicity with zidovudine (AZT) or dideoxycytidine (ddC), including experimental drugs not specifically allowed. - Drugs that could cause seizures or changes in mental status or neurological examination. Concurrent Treatment: Excluded: - Transfusion dependency. Patients with the following are excluded: - Active AIDS defining opportunistic infection or other active intercurrent illness if ongoing treatment requires use of excluded concomitant medication. - Symptomatic visceral Kaposi's sarcoma (KS), progression of KS within the month prior to study entry, or current neoplasms not specifically allowed. - Severe AIDS dementia complex defined by a score of < 23 on the Mini-Mental State Exam. - Signs, symptoms, or history of peripheral neuropathy. - Unwilling or unable to sign informed consent. Prior Medication: Excluded: - Zidovudine (AZT), dideoxycytidine (ddC), or any other antiretroviral nucleoside analog. - Excluded within 90 days of study entry: - Any experimental drug including fluconazole, ganciclovir, foscarnet, erythropoietin, or ribavirin. Excluded within 90 days of study entry: - Drugs that have caused significant nephrotoxicity or significant hepatotoxicity. - Drugs that could cause peripheral neuropathy including phenytoin, hydralazine, metronidazole, and nitrofurantoin. - Systemic corticosteroids or immunomodulators including interferon and interleukin. Prior Treatment: Excluded within 30 days of study entry: - Radiation therapy. Active substance or alcohol abuse.
Total Enrollment: 600
Location and Contact Information:
Comprehensive Clinic / Dr Robert Schwartz
Ft. Myers, Florida, 33901
United States
Univ Hosp of Cleveland / Case Western Reserve Univ
Cleveland, Ohio, 44106
United States
Graduate Hosp
Philadelphia, Pennsylvania, 19146
United States
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, 20007
United States
San Francisco Veterans Administration Med Ctr
San Francisco, California, 94121
United States
N Texas Ctr for AIDS & Clin Rsch
Dallas, Texas, 75219
United States
Saint Michael's Med Ctr
Newark, New Jersey, 07102
United States
UCD Med Ctr
Sacramento, California, 95817
United States
Kaiser Foundation Hosp
Harbor City, California, 90710
United States
Ctr for Special Immunology
Ft. Lauderdale, Florida, 33308
United States
Northwestern Univ Med School
Chicago, Illinois, 60611
United States
New England Med Ctr
Boston, Massachusetts, 02111
United States
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 30308
United States
Davies Med Ctr
San Francisco, California, 94114
United States
Univ TX Galveston Med Branch
Galveston, Texas, 77550
United States
Mount Zion Med Ctr
San Francisco, California, 94115
United States
Henry Ford Hosp
Detroit, Michigan, 48202
United States
Sunset Park Health Ctr - Lutheran Med Ctr
Brooklyn, New York, 11220
United States
Santa Clara Valley Med Ctr
San Jose, California, 95128
United States
Bowman Gray School of Medicine / North Carolina Baptist Hosp
Winston Salem, North Carolina, 27103
United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612
United States
Baylor College of Medicine
Houston, Texas, 77030
United States
Kaiser Permanente Med Ctr
Los Angeles, California, 90027
United States
Albany Med College / AIDS Treatment Ctr
Albany, New York, 12203
United States
Med Service
Miami, Florida, 33125
United States
Additional Information:
Study ID Numbers: ACTG 114; Protocol Number: N3300A,FDA 31A,Study Number: 3-27
Study Start Date:
Record last reviewed: December 1994
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000679
Other Hiv Infections Studies:
1. A Study on the Safety and Effectiveness of Twice-Daily Nelfinavir Plus Twice-Daily Indinavir Plus Efavirenz in HIV-Positive Patients Who Have Never Taken Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) or Protease Inhibitors
2. Pilot Study to Determine the Feasibility of Fluconazole for Induction Treatment and Suppression of Relapse of Histoplasmosis in Patients with the Acquired Immunodeficiency Syndrome
3. A Study to Compare the Safety and Effectiveness of Two Dosing Schedules of Lamivudine in Combination with Two Other Anti-HIV Drugs
4. A Phase I /II Study of the Protease Inhibitor Indinavir (MK-0639) in Children with HIV Infection
5. A Study of ABT-378/Ritonavir Combination in HIV-Infected Patients Who Have Taken Protease Inhibitors
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(Ro 24-2027) A Randomized, Double-Blind, Comparative Study of Dideoxycytidine (ddC) versus Zidovudine (AZT) in Patients With AIDS or Advanced ARC
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