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A Randomized, Double Blind, Comparative Study of Dideoxycytidine (ddC) Alone or ddC/AZT Combination Versus Zidovudine (ZDV) Alone in Patients With HIV Infection Who Have Received Prior ZDV Therapy Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on A Randomized, Double Blind, Comparative Study of Dideoxycytidine (ddC) Alone or ddC/AZT Combination Versus Zidovudine (ZDV) Alone in Patients With HIV Infection Who Have Received Prior ZDV Therapy conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. A Randomized, Double Blind, Comparative Study of Dideoxycytidine (ddC) Alone or ddC/AZT Combination Versus Zidovudine (ZDV) Alone in Patients With HIV Infection Who Have Received Prior ZDV Therapy Clinical research trials and A Randomized, Double Blind, Comparative Study of Dideoxycytidine (ddC) Alone or ddC/AZT Combination Versus Zidovudine (ZDV) Alone in Patients With HIV Infection Who Have Received Prior ZDV Therapy medical trials happen in hundreds of localities 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 typically measure the effectualness of new does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like A Randomized, Double Blind, Comparative Study of Dideoxycytidine (ddC) Alone or ddC/AZT Combination Versus Zidovudine (ZDV) Alone in Patients With HIV Infection Who Have Received Prior ZDV Therapy. A Randomized, Double Blind, Comparative Study of Dideoxycytidine (ddC) Alone or ddC/AZT Combination Versus Zidovudine (ZDV) Alone in Patients With HIV Infection Who Have Received Prior ZDV Therapy Clinical Trials and other clinical trials permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes there is a cost for a A Randomized, Double Blind, Comparative Study of Dideoxycytidine (ddC) Alone or ddC/AZT Combination Versus Zidovudine (ZDV) Alone in Patients With HIV Infection Who Have Received Prior ZDV Therapy clinical trial. Participants frequently obtain the most expert healthcare available for their A Randomized, Double Blind, Comparative Study of Dideoxycytidine (ddC) Alone or ddC/AZT Combination Versus Zidovudine (ZDV) Alone in Patients With HIV Infection Who Have Received Prior ZDV Therapy condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > A Randomized, Double Blind, Comparative Study of Dideoxycytidine (ddC) Alone or ddC/AZT Combination Versus Zidovudine (ZDV) Alone in Patients With HIV Infection Who Have Received Prior ZDV Therapy A Randomized, Double Blind, Comparative Study of Dideoxycytidine (ddC) Alone or ddC/AZT Combination Versus Zidovudine (ZDV) Alone in Patients With HIV Infection Who Have Received Prior ZDV Therapy
A Randomized, Double Blind, Comparative Study of Dideoxycytidine (ddC) Alone or ddC/AZT Combination Versus Zidovudine (ZDV) Alone in Patients With HIV Infection Who Have Received Prior ZDV Therapy
For Condition: HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , Hoffmann-La Roche,Glaxo Wellcome
Synopsis: To evaluate the safety of zalcitabine (dideoxycytidine; ddC) alone and in combination with zidovudine (AZT) versus AZT alone when administered to asymptomatic patients with a CD4 count = or < 200 cells/mm3 and symptomatic patients with a CD4 count = or < 300 cells/mm3. To compare the effectiveness of ddC alone and in combination with AZT versus AZT alone. ddC has been shown to demonstrate an antiviral effect. AZT has been shown to significantly decrease mortality and reduce the frequency of opportunistic infections in patients with AIDS or advanced ARC. After 1 year of AZT therapy, the effectiveness tends to diminish and patients progress with more opportunistic infections and higher mortality rates. Because of the demonstrated antiviral activity, absence of hematologic toxicity, and lack of cross tolerance in laboratory studies of ddC, a study to investigate the long-term effectiveness of ddC in patients with HIV infection who have received AZT therapy is warranted.
Details: ddC has been shown to demonstrate an antiviral effect. AZT has been shown to significantly decrease mortality and reduce the frequency of opportunistic infections in patients with AIDS or advanced ARC. After 1 year of AZT therapy, the effectiveness tends to diminish and patients progress with more opportunistic infections and higher mortality rates. Because of the demonstrated antiviral activity, absence of hematologic toxicity, and lack of cross tolerance in laboratory studies of ddC, a study to investigate the long-term effectiveness of ddC in patients with HIV infection who have received AZT therapy is warranted. Patients are randomly assigned to 1 of 3 treatment groups. In study arm 1, patients receive AZT plus ddC placebo. In study arm 2, patients receive ddC plus AZT placebo capsules. In study arm 3, patients receive ddC plus AZT. Patients are seen every other week for first 8 weeks and monthly thereafter. Patients are stratified by HIV disease status, length of time receiving AZT, and systemic or local Pneumocystis carinii pneumonia (PCP) prophylaxis. Patients who reach a clinical AIDS-defining endpoint are offered open-label combination therapy.
Eligibility:
Study Type: Interventional, Treatment, Double-Blind
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Required: - Zidovudine (AZT) = or > 300 mg/day for 6 weeks prior to study entry. Allowed: - Chemoprophylaxis for Pneumocystis carinii pneumonia (PCP), candidiasis, and herpes. - 21 day course of adjuvant systemic corticosteroids for moderate to severe PCP. - Maintenance treatment with pyrimethamine, sulfadiazine, amphotericin, fluconazole, ketoconazole, acyclovir, ganciclovir, or medications for tuberculosis or Mycobacterium avium for patients who have recovered from toxoplasmosis, cryptococcosis, candidiasis, herpes virus infections, cytomegalovirus infections, tuberculosis or Mycobacterium avium intracellulare. - 14 day course of metronidazole. - Erythropoietin and megace if clinically indicated. - Isoniazid if patient has no peripheral neuropathy at entry and is taking pyridoxine = or > 50 mg/day concomitantly. - Phenytoin if patient has < grade 2 peripheral neuropathy at entry and has been stable on phenytoin = or > 3 months. Patients must have: - Ability and willingness to give informed consent. - Written informed consent from a parent or guardian if < 18 years old. - Been tolerating zidovudine (AZT) therapy. - Diagnosis of HIV infection. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: - Kaposi's sarcoma or other malignancy requiring therapy. - Active opportunistic infections. - Peripheral neuropathy as manifested by complaints of moderate pain, burning, numbness, or tingling in hands/arms or feet/legs; moderate sensory deficit in the upper or lower extremities; or motor weakness in the upper or lower extremities. Concurrent Medication: Excluded: - Other experimental medications. - Other anti-HIV drugs. - Biologic response modifiers. - Cytotoxic chemotherapy. - Drugs that could cause peripheral neuropathy including phenytoin not specifically allowed, hydralazine, nitrofurantoin, vincristine, cisplatinum, dapsone, disulfiram, and diethyldithiocarbamate. Concurrent Treatment: Excluded: - Radiation therapy. Patients with the following are excluded: - Active opportunistic infection. Must have ended acute therapy at least 14 days prior to study entry. - Peripheral neuropathy = or > grade 2. - History of intolerance to 500 to 600 mg/day of zidovudine (AZT) as manifested by the same recurrent grade 3 toxicity requiring dose interruptions and dose reductions to < 500 mg/day or any prior grade 4 toxicity. - Prior development of peripheral neuropathy on ddI = or > grade 2. Prior Medication: Excluded: - Dideoxycytidine (ddC). Required: - Zidovudine (AZT) for total of at least 24 weeks; and included within that time period, AZT = or > 300 mg/day for 6 weeks prior to the study entry.
Total Enrollment: 750
Location and Contact Information:
Overall Study Official:
MFischl, Study Chair,
Mount Sinai Med Ctr
New York City, New York, 10029
United States
Univ of Washington
Seattle, Washington, 981224304
United States
George Washington Univ Med Ctr
Washington D.C., District of Columbia, 20037
United States
Univ of Minnesota
Minneapolis, Minnesota, 55455
United States
Case Western Reserve Univ
Cleveland, Ohio, 44106
United States
Duke Univ Med Ctr
Durham, North Carolina, 27710
United States
Univ Hosp / Univ of Colorado Health Sci Ctr
Denver, Colorado, 80262
United States
Med College of Ohio
Toledo, Ohio, 43699
United States
UCLA CARE Ctr
Los Angeles, California, 90095
United States
Indiana Univ Hosp
Indianapolis, Indiana, 462025250
United States
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, 900331079
United States
SUNY - Stony Brook
Stony Brook, New York, 117948153
United States
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
Newark, New Jersey, 071032714
United States
Univ of California / San Diego Treatment Ctr
San Diego, California, 921036325
United States
Boston Med Ctr
Boston, Massachusetts, 02118
United States
Cornell Univ Med Ctr
New York City, New York, 10021
United States
Palo Alto Veterans Adm Med Ctr / Stanford Univ
Palo Alto, California, 94304
United States
Univ of Cincinnati
Cincinnati, Ohio, 452670405
United States
UCSD Med Ctr / Pediatrics / Clinical Sciences
La Jolla, California, 920930672
United States
Jack Weiler Hosp / Bronx Municipal Hosp
Bronx, New York, 10465
United States
Montefiore Med Ctr / Bronx Municipal Hosp
Bronx, New York, 10467
United States
St Louis Regional Hosp / St Louis Regional Med Ctr
St. Louis, Missouri, 63112
United States
Ohio State Univ Hosp Clinic
Columbus, Ohio, 432101228
United States
Beth Israel Med Ctr
New York City, New York, 10003
United States
Children's Hosp of Boston
Boston, Massachusetts, 021155724
United States
North Central Bronx Hosp / Bronx Municipal Hosp
Bronx, New York, 10467
United States
Mem Sloan - Kettering Cancer Ctr
New York City, New York, 10021
United States
Sepulveda Veterans Adm Med Ctr / Olive View Med Ctr
Sylmar, California, 91342
United States
Stanford Private Practice
Redwood City, California,
United States
Bronx Veterans Administration / Mount Sinai Hosp
Bronx, New York, 10468
United States
Bowman Gray School of Medicine / Wake Forest Univ
Winston Salem, North Carolina, 27103
United States
City Hosp Ctr at Elmhurst / Mount Sinai Hosp
Elmhurst, New York, 11373
United States
Saint Luke's - Roosevelt Hosp Ctr
New York City, New York, 10025
United States
Bronx Municipal Hosp Ctr/Jacobi Med Ctr
Bronx, New York, 10461
United States
Univ of North Carolina
Chapel Hill, North Carolina, 275997215
United States
Beth Israel Deaconess - West Campus
Boston, Massachusetts, 02215
United States
Columbus Children's Hosp
Columbus, Ohio, 432052696
United States
Olive View Med Ctr
Sylmar, California, 91342
United States
Johns Hopkins Hosp
Baltimore, Maryland, 21287
United States
Stanford at Kaiser / Kaiser Permanente Med Ctr
San Francisco, California, 94115
United States
Beth Israel Deaconess Med Ctr
Boston, Massachusetts, 02215
United States
Baystate Med Ctr of Springfield
Springfield, Massachusetts, 01199
United States
Harvard (Massachusetts Gen Hosp)
Boston, Massachusetts, 02114
United States
Moses H Cone Memorial Hosp
Greensboro, North Carolina, 27401
United States
Univ of Pittsburgh
Pittsburgh, Pennsylvania, 15213
United States
Nassau County Med Ctr
East Meadow, New York, 11554
United States
Harbor UCLA Med Ctr
Torrance, California, 90502
United States
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
Univ of Miami School of Medicine
Miami, Florida, 331361013
United States
Julio Arroyo
West Columbia, South Carolina, 29169
United States
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, 14215
United States
Additional Information:
Study ID Numbers: ACTG 155;
Study Start Date:
Record last reviewed: January 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000651
Other Hiv Infections Studies:
1. A Study to Compare the Efficacy and Safety of Valacyclovir Hydrochloride ( 256U87 ) Versus Acyclovir in the Treatment of Recurrent Anogenital Herpes Infections in HIV Infected Patients
2. A Study of CI-1012 in HIV-Infected Patients
3. Helping HIV Infected Patients in South Africa Adhere to Drug Regimens
4. HIV Prevention Counseling for Men Who Have Sex with Men
5. Double-Blind, Randomized, Placebo-Controlled Study of Low Dose Oral Interferon Alfa-n3 (Human Leukocyte Derived) in ARC Patients
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A Randomized, Double Blind, Comparative Study of Dideoxycytidine (ddC) Alone or ddC/AZT Combination Versus Zidovudine (ZDV) Alone in Patients With HIV Infection Who Have Received Prior ZDV Therapy
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