|
A Study of Dideoxyinosine (ddI) in HIV-Infected Children Who Have Not Had Success with Zidovudine or Who Cannot Take Zidovudine Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on A Study of Dideoxyinosine (ddI) in HIV-Infected Children Who Have Not Had Success with Zidovudine or Who Cannot Take Zidovudine conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. A Study of Dideoxyinosine (ddI) in HIV-Infected Children Who Have Not Had Success with Zidovudine or Who Cannot Take Zidovudine Clinical research trials and A Study of Dideoxyinosine (ddI) in HIV-Infected Children Who Have Not Had Success with Zidovudine or Who Cannot Take Zidovudine healthcare trials happen in a lot of of localities across 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 generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as A Study of Dideoxyinosine (ddI) in HIV-Infected Children Who Have Not Had Success with Zidovudine or Who Cannot Take Zidovudine. A Study of Dideoxyinosine (ddI) in HIV-Infected Children Who Have Not Had Success with Zidovudine or Who Cannot Take Zidovudine Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a A Study of Dideoxyinosine (ddI) in HIV-Infected Children Who Have Not Had Success with Zidovudine or Who Cannot Take Zidovudine clinical trial. Human subjects often receive the most effective healthcare possible for their A Study of Dideoxyinosine (ddI) in HIV-Infected Children Who Have Not Had Success with Zidovudine or Who Cannot Take Zidovudine condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "A" Clinical Trials Conditions > A Study of Dideoxyinosine (ddI) in HIV-Infected Children Who Have Not Had Success with Zidovudine or Who Cannot Take Zidovudine  A Study of Dideoxyinosine (ddI) in HIV-Infected Children Who Have Not Had Success with Zidovudine or Who Cannot Take Zidovudine
A Study of Dideoxyinosine (ddI) in HIV-Infected Children Who Have Not Had Success with Zidovudine or Who Cannot Take Zidovudine
For Condition: HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , Bristol-Myers Squibb
Synopsis: To evaluate the effectiveness, safety, and tolerance of two doses of didanosine (ddI) in the treatment of children with symptomatic HIV disease who have had to discontinue zidovudine (AZT) because of intolerance and/or who have experienced progressive disease while on AZT. The progression of immunodeficiency due to HIV infection can be delayed by using AZT. The benefits of AZT in adults with AIDS and severe AIDS-related complex (ARC) appear to last for approximately 12 to 18 months, at which time most patients have progressive deterioration. Recently published literature has described a reduced sensitivity of HIV isolated from patients after prolonged AZT treatment. Although the clinical significance of this is unclear, it makes the development of new antiretroviral drugs important.
Details: The progression of immunodeficiency due to HIV infection can be delayed by using AZT. The benefits of AZT in adults with AIDS and severe AIDS-related complex (ARC) appear to last for approximately 12 to 18 months, at which time most patients have progressive deterioration. Recently published literature has described a reduced sensitivity of HIV isolated from patients after prolonged AZT treatment. Although the clinical significance of this is unclear, it makes the development of new antiretroviral drugs important. Children who show AZT intolerance and/or progressive disease after 6 months of AZT therapy receive oral ddI at 1 of 2 doses for a minimum of 48 weeks, with a 48-week extension. Patients are seen for clinical and laboratory evaluations at scheduled times during the study. (Per 5/12/92 amendment, new patients will not be enrolled in the pharmacokinetics studies.) Per 10/31/94 amendment: Patients are eligible to receive blinded study drug for an additional 8-16 weeks after the final on-study visit, but no later than 2/15/95.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 3 Months/18 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: - Prophylaxis treatment for Pneumocystis carinii pneumonia (PCP). - Immunoglobulin. - Maintenance therapy with amphotericin B (l mg/kg) up to 5 days/week. Concurrent Treatment: Allowed: - Blood transfusions. Prior Medication: Allowed: - Prophylaxis treatment for Pneumocystis carinii pneumonia (PCP). Patients enrolled in ACTG 128 and ACTG 138 must meet study end points or meet protocol definitions for being permanently off zidovudine (AZT) before enrolling in this study. - Patients currently enrolled in ACTG 051 who have not reached the study end points but who meet the entry criteria for ACTG 144 may be co-enrolled in ACTG 144. - Patient or guardian available to give written informed consent. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded. - Hypersensitivity to didanosine (ddI). - Symptomatic cardiomyopathy. - Seizures that are not well controlled by ongoing anticonvulsant therapy. - Symptomatic pancreatitis. - Grade 1 or higher peripheral neuropathy. - Active malignancy requiring chemotherapy. Concurrent Medication: Excluded: - Zidovudine (AZT), other antiretroviral agents, biological modifiers, and investigational medications. Avoid: - Drugs with potential to cause peripheral neuropathy or pancreatitis. Patients with the following are excluded: - Active malignancy requiring concomitant chemotherapy. Prior Medication: Excluded: - Antiretroviral agents other than zidovudine (AZT) or dideoxycytidine (ddC) within 4 weeks of study entry. - Immunomodulating agents such as interferons, isoprinosine, or interleukin-2 within 2 weeks of entry. - Any other experimental therapy within 1 week of entry. - Drugs that have or will cause prolonged neutropenia, significant pancreatitis, significant nephrotoxicity, or peripheral neuropathy within 1 week of entry.
Total Enrollment: 300
Location and Contact Information:
Overall Study Official:
FrenkelLM, Study Chair,
Cedars Sinai / UCLA Med Ctr
Los Angeles, California, 900481804
United States
Univ of Alabama at Birmingham Schl of Med / Pediatrics
Birmingham, Alabama, 35294
United States
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033
United States
Yale Univ Med School
New Haven, Connecticut, 06504
United States
Children's Hosp of Philadelphia
Philadelphia, Pennsylvania, 191044318
United States
Univ of Miami (Pediatric)
Miami, Florida, 33161
United States
Metropolitan Hosp Ctr
New York City, New York, 10029
United States
Children's Hosp of Boston
Boston, Massachusetts, 021155724
United States
Univ of Massachusetts Med Ctr
Worcester, Massachusetts, 01655
United States
Mount Sinai Med Ctr / Pediatrics
New York City, New York, 10029
United States
Schneider Children's Hosp
New Hyde Park, New York, 11040
United States
Cincinnati Children's Hosp / Univ Hosp
Cincinnati, Ohio, 452292899
United States
Boston City Hosp / Pediatrics
Boston, Massachusetts, 02118
United States
Harlem Hosp Ctr
New York City, New York, 10037
United States
SUNY / Health Sciences Ctr at Brooklyn / Pediatrics
Brooklyn, New York, 11203
United States
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
Albert Einstein College of Medicine
Bronx, New York, 10461
United States
North Shore Univ Hosp
Great Neck, New York, 11021
United States
Cornell Univ Med College
New York City, New York, 10021
United States
Saint Christopher's Hosp for Children
Philadelphia, Pennsylvania, 191341095
United States
Columbus Children's Hosp
Columbus, Ohio, 432052696
United States
Westchester Hosp
Valhalla, New York, 10595
United States
Children's Hosp of New Jersey / UMDNJ - New Jersey Med Schl
Newark, New Jersey, 071072198
United States
UPR Children's Hosp / UPR School of Medicine
San Juan, , 009365067
Puerto Rico
Incarnation Children's Ctr / Columbia Presbyterian Med Ctr
New York City, New York, 10032
United States
Columbia Presbyterian Med Ctr
New York City, New York, 10032
United States
Univ of Chicago Children's Hosp
Chicago, Illinois, 606371470
United States
Baystate Med Ctr of Springfield
Springfield, Massachusetts, 01199
United States
Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl
Newark, New Jersey, 07103
United States
UCLA Med Ctr / Pediatric
Los Angeles, California, 900951752
United States
Emory Univ Hosp / Pediatrics
Atlanta, Georgia, 30306
United States
Children's Hosp at Albany Med Ctr
Albany, New York, 12208
United States
Children's Hosp of Washington DC / Children's Natl Med Ctr
Washington D.C., District of Columbia, 20010
United States
Duke Univ Med Ctr
Durham, North Carolina, 277103499
United States
Chicago Children's Memorial Hosp
Chicago, Illinois, 606143394
United States
Case Western Reserve Univ
Cleveland, Ohio, 44106
United States
Med Univ of South Carolina
Charleston, South Carolina, 29425
United States
Children's Hosp of Washington DC
Washington D.C., District of Columbia, 200102916
United States
Hermann Hosp / Univ Texas Health Science Ctr
Houston, Texas, 77030
United States
SUNY - Brooklyn
Brooklyn, New York, 11203
United States
Bronx Lebanon Hosp Ctr / Pediatrics
Bronx, New York, 10457
United States
Connecticut Children's Med Ctr
Farmington, Connecticut, 060303805
United States
Univ of Rochester Medical Center
Rochester, New York, 14642
United States
Long Beach Memorial (Pediatric)
Long Beach, California, 90801
United States
Univ of Connecticut Health Ctr
Farmington, Connecticut, 06032
United States
Ramon Ruiz Arnau Univ Hosp / Pediatrics
Bayamon, , 00956
Puerto Rico
Children's Hosp of Denver
Denver, Colorado, 802181088
United States
Harbor - UCLA Med Ctr / UCLA School of Medicine
Los Angeles, California, 905022004
United States
Univ of Illinois College of Medicine / Pediatrics
Chicago, Illinois, 60612
United States
Bronx Lebanon Hosp Ctr
Bronx, New York, 10457
United States
Cook County Hosp
Chicago, Illinois, 60612
United States
Hemophilia Ctr of Western PA / Univ of Pittsburgh
Pittsburgh, Pennsylvania, 15219
United States
Children's Med Ctr of Dallas
Dallas, Texas, 75235
United States
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, 200072197
United States
Beth Israel Med Ctr / Pediatrics
New York City, New York, 10003
United States
Children's Hosp of Oakland
Oakland, California, 946091809
United States
Children's Hosp of Michigan
Detroit, Michigan, 48201
United States
Univ of Maryland at Baltimore / Univ Med Ctr
Baltimore, Maryland, 21201
United States
San Juan City Hosp
San Juan, , 009367344
Puerto Rico
SUNY Health Sciences Ctr at Syracuse / Pediatrics
Syracuse, New York, 13210
United States
Univ of Puerto Rico / Univ Children's Hosp AIDS
San Juan, , 009365067
Puerto Rico
Texas Children's Hosp / Baylor Univ
Houston, Texas, 77030
United States
State Univ of New York at Stony Brook
Stony Brook, New York, 117948111
United States
UCSD Med Ctr / Pediatrics / Clinical Sciences
La Jolla, California, 920930672
United States
UCSF / Moffitt Hosp - Pediatric
San Francisco, California, 941430105
United States
Howard Univ Hosp
Washington D.C., District of Columbia, 20060
United States
Children's Hosp of Seattle
Seattle, Washington, 98105
United States
Johns Hopkins Hosp - Pediatric
Baltimore, Maryland, 212874933
United States
Additional Information:
Study ID Numbers: ACTG 144;
Study Start Date:
Record last reviewed: January 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000963
Other Hiv Infections Studies:
1. HIV Infection in Homosexual and Bisexual Men
2. A Phase I/II Study of the Safety, Tolerance, and Pharmacokinetics of 9-(2-Phosphonylmethoxyethyl)adenine ( PMEA; Adefovir ) in Patients With Advanced HIV Disease.
3. The Treatment of Tuberculosis in HIV-Infected Patients
4. New Tablet Containing Two FDA Approved Anti-HIV Drugs For Antiretroviral Therapy Experienced HIV-1 Infected Subjects
5. Use of Muscle Spectroscopy to Evaluate Mitochondrial Dysfunction in HIV-Infected Patients
Related Studies:
Other HIV Infections Clinical Trials
Other New York Clinical Trials
Other Bronx Clinical Trials
A Study of Dideoxyinosine (ddI) in HIV-Infected Children Who Have Not Had Success with Zidovudine or Who Cannot Take Zidovudine
|
|
|
|
|
|
|
|
