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A Study of Dideoxycytidine Plus Zidovudine (AZT) in HIV-Infected Children Who Have Taken AZT Clinical Trials References presented on Clinical Trials Search isn't meant to be a substitute for proven healthcare advice, trips or professional assistance using a genuine physician. We are not docs. Always confer with your physician about A Study of Dideoxycytidine Plus Zidovudine (AZT) in HIV-Infected Children Who Have Taken AZT conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. A Study of Dideoxycytidine Plus Zidovudine (AZT) in HIV-Infected Children Who Have Taken AZT Clinical research trials and A Study of Dideoxycytidine Plus Zidovudine (AZT) in HIV-Infected Children Who Have Taken AZT healthcare trials happen in hundreds of localities 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 usually evaluate the potency of new drugs. The propose of the studies / projects is to answer particular human health questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to detect cures for all sorts of conditions, such as A Study of Dideoxycytidine Plus Zidovudine (AZT) in HIV-Infected Children Who Have Taken AZT. A Study of Dideoxycytidine Plus Zidovudine (AZT) in HIV-Infected Children Who Have Taken AZT Clinical Trials and other clinical trials allow volunteers to acquire healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a A Study of Dideoxycytidine Plus Zidovudine (AZT) in HIV-Infected Children Who Have Taken AZT clinical trial. Subjects frequently obtain the most expert healthcare possible for their A Study of Dideoxycytidine Plus Zidovudine (AZT) in HIV-Infected Children Who Have Taken AZT condition. Risks are a reality, nevertheless, and can include more or frequent doctor trips, medical risks (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with stern guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > A Study of Dideoxycytidine Plus Zidovudine (AZT) in HIV-Infected Children Who Have Taken AZT  A Study of Dideoxycytidine Plus Zidovudine (AZT) in HIV-Infected Children Who Have Taken AZT
A Study of Dideoxycytidine Plus Zidovudine (AZT) in HIV-Infected Children Who Have Taken AZT
For Condition: HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: PRIMARY: To determine safety, tolerance, and pharmacokinetics of zidovudine (AZT) and zalcitabine (dideoxycytidine; ddC) when given in combination in clinically stable AZT-treated children. SECONDARY: To compare combination therapy with mono drug therapy for antiviral activity and laboratory markers of disease progression, as determined by virologic and immunologic determinations. To evaluate the influence of combination therapy on disease progression as determined by evaluation of clinical criteria. In children currently being treated with AZT, it is unknown whether the addition of another antiretroviral agent such as ddC would help increase efficacy and tolerance. This study will examine the possible advantages of combination AZT/ddC therapy over monotherapy with AZT alone.
Details: In children currently being treated with AZT, it is unknown whether the addition of another antiretroviral agent such as ddC would help increase efficacy and tolerance. This study will examine the possible advantages of combination AZT/ddC therapy over monotherapy with AZT alone. Patients are stratified according to duration of ongoing AZT therapy and are randomized to receive AZT either alone or in combination with ddC. Patients receive therapy until the last patient enrolled completes 32 weeks of therapy. The study may be extended for two additional 32-week periods on an optional basis.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 3 Months/12 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Recommended: - PCP prophylaxis. Allowed: - Intravenous and/or intramuscular immunoglobulin. - Acyclovir (no more than 30 mg/kg/day PO). - Ketoconazole (no more than 10 mg/kg/day). - Nystatin. - Aspirin, acetaminophen, nonsteroidal anti-inflammatory drugs, sedatives, and barbiturates, not to exceed 72 hours. - Isoniazid in combination with pyridoxine, provided there is no evidence of peripheral neuropathy. - Trimethoprim / sulfamethoxazole. - Amphotericin B (no more than 1 mg/kg for 5 days/week). - Aerosolized ribavirin for bronchiolitis. - Hematopoietic agents. - Other drugs with little nephro-, hepato-, or cytotoxicity. - Nutritional support for HIV wasting syndrome or malnutrition. Patients must have: - HIV infection. - Ongoing stable AZT therapy. Exclusion Criteria Co-existing Condition: Patients with the following symptoms and conditions are excluded: - Disease progression while on AZT, to the extent that the patient meets the criteria for advanced disease protocols. - Known allergy or sensitivity to ddC. - Cardiomyopathy. Concurrent Medication: Excluded: - Biologic modifiers other than IVIG, steroids, or hematopoietic agents. - Investigational medications unless approved by protocol chair. - Medications known to cause pancreatitis (unless ddC is interrupted while these medications are given). Patients with the following prior conditions are excluded: - History of intolerance or toxicity to AZT. - History of symptomatic pancreatitis. - History of peripheral neuropathy or abnormal nerve conduction velocity test. Prior Medication: Excluded: - Antiretroviral agents other than AZT within 2 weeks of study entry. Required: - Ongoing stable AZT therapy for more than 6 weeks duration.
Total Enrollment: 180
Location and Contact Information:
Overall Study Official:
SPahwa, Study Chair,
Stanford Univ School of Medicine / Pediatrics
Stanford, California, 943054149
United States
Univ of Miami (Pediatric)
Miami, Florida, 33161
United States
Chicago Children's Memorial Hosp
Chicago, Illinois, 606143394
United States
SUNY Health Sciences Ctr at Syracuse / Pediatrics
Syracuse, New York, 13210
United States
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033
United States
Yale Univ Med School
New Haven, Connecticut, 06504
United States
Univ of Maryland at Baltimore / Univ Med Ctr
Baltimore, Maryland, 21201
United States
Children's Hosp of Michigan
Detroit, Michigan, 48201
United States
UCLA Med Ctr / Pediatric
Los Angeles, California, 900951752
United States
Emory Univ Hosp / Pediatrics
Atlanta, Georgia, 30306
United States
Univ of Connecticut / Farmington
Farmington, Connecticut, 06032
United States
Bronx Lebanon Hosp Ctr
Bronx, New York, 10457
United States
Children's Hosp of Boston
Boston, Massachusetts, 021155724
United States
Children's Hosp of Washington DC
Washington D.C., District of Columbia, 200102916
United States
Boston City Hosp / Pediatrics
Boston, Massachusetts, 02118
United States
Cook County Hosp
Chicago, Illinois, 60612
United States
SUNY - Brooklyn
Brooklyn, New York, 11203
United States
Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl
Newark, New Jersey, 07103
United States
Baystate Med Ctr of Springfield
Springfield, Massachusetts, 01199
United States
Schneider Children's Hosp
New Hyde Park, New York, 11040
United States
Children's Hosp of Philadelphia
Philadelphia, Pennsylvania, 191044318
United States
Harbor - UCLA Med Ctr / UCLA School of Medicine
Los Angeles, California, 905022004
United States
Children's Hospital & Medical Center / Seattle ACTU
Seattle, Washington, 981050371
United States
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, 20007
United States
Metropolitan Hosp Ctr
New York City, New York, 10029
United States
Albert Einstein College of Medicine
Bronx, New York, 10461
United States
Rhode Island Hosp / Brown Univ
Providence, Rhode Island, 02903
United States
Long Beach Memorial (Pediatric)
Long Beach, California, 90801
United States
Univ of Illinois College of Medicine / Pediatrics
Chicago, Illinois, 60612
United States
Med Univ of South Carolina
Charleston, South Carolina, 294253312
United States
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
Columbia Presbyterian Med Ctr
New York City, New York, 10032
United States
Tulane Univ / Charity Hosp of New Orleans
New Orleans, Louisiana, 701122699
United States
Mount Sinai Med Ctr / Pediatrics
New York City, New York, 10029
United States
Children's Hosp at Albany Med Ctr
Albany, New York, 12208
United States
North Shore Univ Hosp
Great Neck, New York, 11021
United States
Mount Sinai Med Ctr
New York City, New York, 10029
United States
King's County Hosp Ctr / Pediatrics
Brooklyn, New York, 11203
United States
Children's Hosp of New Jersey / UMDNJ - New Jersey Med Schl
Newark, New Jersey, 071072198
United States
Westchester Hosp
Valhalla, New York, 10595
United States
Sunnybrook Health Science Ctr
Toronto, Ontario,
Canada
UCSD Med Ctr / Pediatrics / Clinical Sciences
La Jolla, California, 920930672
United States
Children's Hosp Pact Prog / Children's Hosp of Buffalo
Buffalo, New York, 14222
United States
Children's Hosp of Oakland
Oakland, California, 946091809
United States
Columbus Children's Hosp
Columbus, Ohio, 432052696
United States
Saint Christopher's Hosp for Children
Philadelphia, Pennsylvania, 191341095
United States
Univ of Puerto Rico / Univ Children's Hosp AIDS
San Juan, , 009365067
Puerto Rico
Children's Hosp of Denver
Denver, Colorado, 802181088
United States
Univ of Chicago Children's Hosp
Chicago, Illinois, 606371470
United States
Duke Univ Med Ctr
Durham, North Carolina, 277103499
United States
Lincoln Hosp Ctr
Bronx, New York, 10451
United States
Univ of Alabama at Birmingham Schl of Med / Pediatrics
Birmingham, Alabama, 35294
United States
San Francisco Gen Hosp
San Francisco, California, 94110
United States
Howard Univ Hosp
Washington D.C., District of Columbia, 20060
United States
Incarnation Children's Ctr / Columbia Presbyterian Med Ctr
New York City, New York, 10032
United States
San Juan City Hosp
San Juan, , 009367344
Puerto Rico
Cedars Sinai / UCLA Med Ctr
Los Angeles, California, 900481804
United States
Ramon Ruiz Arnau Univ Hosp / Pediatrics
Bayamon, , 00956
Puerto Rico
Univ of Rochester Medical Center
Rochester, New York, 14642
United States
Univ of Massachusetts Med School
Worcester, Massachusetts, 016550001
United States
UCSF / Moffitt Hosp - Pediatric
San Francisco, California, 941430105
United States
Additional Information:
Study ID Numbers: ACTG 190;
Study Start Date:
Record last reviewed: May 1995
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001032
Other Hiv Infections Studies:
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3. A Double-Blind, Placebo-Controlled Study With Open-Label Follow-Up To Determine the Safety and Efficacy of r-HuEPO in AIDS Patients With Anemia Induced by Their Disease and AZT Therapy
4. Comparative Randomized Study of the Efficacy, Safety, and Toleration of Fluconazole Oral Suspension or Nystatin Oral Suspension in the Treatment of Patients With Oropharyngeal Candidiasis in Association With the Acquired Immunodeficiency Syndrome
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A Study of Dideoxycytidine Plus Zidovudine (AZT) in HIV-Infected Children Who Have Taken AZT
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