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A Trial of Two Doses of 2',3'-Dideoxycytidine (ddC) in the Treatment of Children With Symptomatic HIV Infection Who Are Intolerant of AZT and/or Who Show Progressive Disease While on AZT Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on A Trial of Two Doses of 2',3'-Dideoxycytidine (ddC) in the Treatment of Children With Symptomatic HIV Infection Who Are Intolerant of AZT and/or Who Show Progressive Disease While on AZT conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. A Trial of Two Doses of 2',3'-Dideoxycytidine (ddC) in the Treatment of Children With Symptomatic HIV Infection Who Are Intolerant of AZT and/or Who Show Progressive Disease While on AZT Clinical research trials and A Trial of Two Doses of 2',3'-Dideoxycytidine (ddC) in the Treatment of Children With Symptomatic HIV Infection Who Are Intolerant of AZT and/or Who Show Progressive Disease While on AZT medical trials occur in many of places across 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 generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including A Trial of Two Doses of 2',3'-Dideoxycytidine (ddC) in the Treatment of Children With Symptomatic HIV Infection Who Are Intolerant of AZT and/or Who Show Progressive Disease While on AZT. A Trial of Two Doses of 2',3'-Dideoxycytidine (ddC) in the Treatment of Children With Symptomatic HIV Infection Who Are Intolerant of AZT and/or Who Show Progressive Disease While on AZT Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a A Trial of Two Doses of 2',3'-Dideoxycytidine (ddC) in the Treatment of Children With Symptomatic HIV Infection Who Are Intolerant of AZT and/or Who Show Progressive Disease While on AZT clinical trial. Participants oftentimes recieve the finest healthcare available for their A Trial of Two Doses of 2',3'-Dideoxycytidine (ddC) in the Treatment of Children With Symptomatic HIV Infection Who Are Intolerant of AZT and/or Who Show Progressive Disease While on AZT condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), 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 Trial of Two Doses of 2',3'-Dideoxycytidine (ddC) in the Treatment of Children With Symptomatic HIV Infection Who Are Intolerant of AZT and/or Who Show Progressive Disease While on AZT  A Trial of Two Doses of 2',3'-Dideoxycytidine (ddC) in the Treatment of Children With Symptomatic HIV Infection Who Are Intolerant of AZT and/or Who Show Progressive Disease While on AZT
A Trial of Two Doses of 2',3'-Dideoxycytidine (ddC) in the Treatment of Children With Symptomatic HIV Infection Who Are Intolerant of AZT and/or Who Show Progressive Disease While on AZT
For Condition: HIV Infections
Status: Completed
Sponsor(s): Hoffmann-La Roche , National Institute of Allergy and Infectious Diseases (NIAID)
Synopsis: To evaluate and compare the long-term (48-177 weeks) safety, tolerance, and efficacy of two doses of zalcitabine ( dideoxycytidine; ddC ) taken orally every 8 hours in children with symptomatic HIV infection who have one of the following: intolerance to zidovudine ( AZT ) (development of toxicity during prolonged AZT therapy), demonstrated disease progression after 6 months of AZT therapy, OR both AZT intolerance and disease progression after 6 months of AZT therapy. As useful as AZT appears to be in the treatment of patients infected with HIV, it is associated with significant toxicity in some patients, and it does not prevent ultimate progression to AIDS and eventual mortality. Thus, there is a clear need for new antiretroviral drugs, and ddC is one such promising agent.
Details: As useful as AZT appears to be in the treatment of patients infected with HIV, it is associated with significant toxicity in some patients, and it does not prevent ultimate progression to AIDS and eventual mortality. Thus, there is a clear need for new antiretroviral drugs, and ddC is one such promising agent. Patients receive oral ddC for 48 to 177 weeks.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 3 Months/18 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: - Procrit. - Amphotericin B (1 mg/kg up to 5 days/week). - Prophylaxis treatment as per ACTG recommendations for Pneumocystis carinii pneumonia. - Acyclovir (up to 1000 mg/day PO; for > 1000 mg/day PO or for any IV dose, suggest interrupting ddC). - Ketoconazole (up to 10 mg/kg/day). - Nystatin. - Aspirin, acetaminophen, sedatives, and barbiturates (for up to 72 hours). - Isoniazid (INH), if there is no evidence of peripheral neuropathy at entry. Children should receive pyridoxine, 25 - 50 mg/day to avoid possible INH-associated neuropathy. - Trimethoprim / sulfamethoxazole (T/S). - Immunoglobulin therapy. - Aerosolized pentamidine. - Drugs with little nephro-, hepato-, cytotoxicity that the patient has been taking and tolerating well for an ongoing condition. Concurrent Treatment: Allowed: - Immunoglobulin therapy. - Nutritional support (for children with wasting syndrome and/or malnutritional) including hyperalimentation (TPN) of dietary supplements. AMENDED: - Patients enrolled in ACTG 051 may participate in ACTG 138 if they show intolerance to AZT or show disease progression after 6 months of AZT therapy and meet entry criteria for the study. ORIGINAL design: - Patients enrolled in ACTG protocols 051 or 128 must meet study end points or meet protocol definitions for being permanently off zidovudine (AZT) before enrolling in this protocol. Patients must have the following: - Absence of acute opportunistic infection at time of entry. - However, if patient is successfully treated for opportunistic infection and has remained stable for 2 weeks after treatment, the patient is then allowed to enter the study. Children receiving maintenance therapy for > 4 weeks are eligible. - Parent or guardian available to give written informed consent. Allowed at time of study entry: - Prophylaxis treatment as per ACTG recommendations, for Pneumocystis carinii pneumonia (PCP). - Immunoglobulin therapy. Prior Medication: AMENDED: - AZT or ddI up until study entry, other antiretrovirals up until 4 weeks of study entry Allowed: - Zidovudine (AZT) within 4 weeks of entry. - Dideoxyinosine (ddI) within 43 weeks of entry if no peripheral neuropathy has been observed while receiving ddI. - Other toxicities observed while on ddI must resolve to level 2 or better before patient can begin treatment with ddC. - Vitamin, folate, iron supplements. Exclusion Criteria Co-existing Condition: AMENDED: - 04-25-91 Additional excluded symptoms and conditions: - Symptomatic cardiomyopathy. - Seizures which are not well controlled by ongoing anticonvulsant therapy. - Active malignancy requiring concomitant chemotherapy. - Symptomatic pancreatitis. - Grade I or greater peripheral neuropathy. - Receiving concomitant zidovudine (AZT). - Patients with the following conditions or symptoms are excluded: - Acute bacterial infections requiring IV or oral antibiotic treatment at time of entry. - Known hypersensitivity to dideoxycytidine (ddC). Concurrent Medication: Excluded: - Other antiviral agents, biological modifiers, and investigational medications. - Drugs with potential to cause peripheral neuropathy, including chloramphenicol, iodoquinol, phenytoin, ethionamide, gold, ribavirin, vincristine, cisplatin, dapsone, disulfiram, glutethimide, hydralazine, metronidazole, nitrofurantoin. Patients with the following are excluded: - Acute bacterial infections requiring IV or oral antibiotic treatment at time of entry. - Known hypersensitivity to dideoxycytidine (ddC). - Active opportunistic infection requiring treatment with an excluded concomitant medication. Prior Medication: Excluded: - Antiretroviral agents (other than zidovudine (AZT) or didanosine (ddI)) within 4 weeks of entry. - Immunomodulating agents such as interferons, isoprinosine, or interleukin-2 within 2 weeks of entry. - Any other experimental therapy, drugs that cause prolonged neutropenia, significant nephrotoxicity, or peripheral neuropathy within 1 week of entry.
Total Enrollment: 140
Location and Contact Information:
Overall Study Official:
SpectorSA, Study Chair,
Univ of Connecticut Health Ctr / Pediatrics
Farmington, Connecticut, 06032
United States
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033
United States
Univ of North Carolina
Chapel Hill, North Carolina, 275997215
United States
Univ of Rochester Medical Center
Rochester, New York, 14642
United States
Duke Univ Med Ctr
Durham, North Carolina, 277103499
United States
Boston City Hosp / Pediatrics
Boston, Massachusetts, 02118
United States
Univ of Massachusetts Med Ctr
Worcester, Massachusetts, 01655
United States
Univ of Maryland at Baltimore / Univ Med Ctr
Baltimore, Maryland, 21201
United States
Emory Univ School of Medicine
Atlanta, Georgia, 30303
United States
SUNY / Health Sciences Ctr at Brooklyn / Pediatrics
Brooklyn, New York, 11203
United States
Schneider Children's Hosp / Long Island Jewish Med Ctr
New Hyde Park, New York, 11042
United States
Cedars Sinai / UCLA Med Ctr
Los Angeles, California, 900481804
United States
Johns Hopkins Hosp - Pediatric
Baltimore, Maryland, 212874933
United States
Mount Sinai Med Ctr / Pediatrics
New York City, New York, 10029
United States
Univ of Illinois College of Medicine
Chicago, Illinois, 60612
United States
Cornell Univ Med Ctr
New York City, New York, 10021
United States
Northshore Hosp / Cornell Univ
Manhasset, New York, 11030
United States
Saint Luke's - Roosevelt Hosp Ctr
New York City, New York, 10025
United States
Lincoln Hosp Ctr / Pediatrics
Bronx, New York, 10451
United States
Columbia Presbyterian Med Ctr
New York City, New York, 10032
United States
Saint Christopher's Hosp for Children
Philadelphia, Pennsylvania, 191341095
United States
Children's Hosp of Boston
Boston, Massachusetts, 021155724
United States
UCSD Med Ctr / Pediatrics / Clinical Sciences
La Jolla, California, 920930672
United States
Cook County Hosp
Chicago, Illinois, 60612
United States
Stanford Univ School of Medicine / Pediatrics
Stanford, California, 943054149
United States
Children's Hosp of Washington DC / Children's Natl Med Ctr
Washington D.C., District of Columbia, 20010
United States
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
Westchester Hosp
Valhalla, New York, 10595
United States
Beth Israel Med Ctr / Pediatrics
New York City, New York, 10003
United States
Texas Children's Hosp / Baylor Univ
Houston, Texas, 77030
United States
Bronx Lebanon Hosp Ctr
Bronx, New York, 10456
United States
Kaiser Permanente / UCLA Med Ctr
Downey, California, 902422814
United States
Ramon Ruiz Arnau Univ Hosp / Pediatrics
Bayamon, , 00619
Puerto Rico
Northern California Pediatric AIDS Treatment Ctr / UCSF
San Francisco, California, 94143
United States
Children's Hosp of Oakland
Oakland, California, 946091809
United States
Univ of Miami (Pediatric)
Miami, Florida, 33161
United States
UPR Children's Hosp / San Juan City Hosp
San Juan, , 00936
Puerto Rico
Children's Hosp of New Jersey / UMDNJ - New Jersey Med Schl
Newark, New Jersey, 071072198
United States
Chicago Children's Memorial Hosp
Chicago, Illinois, 606143394
United States
Baystate Med Ctr of Springfield
Springfield, Massachusetts, 01199
United States
UCLA Med Ctr / Pediatric
Los Angeles, California, 900951752
United States
Harlem Hosp Ctr
New York City, New York, 10037
United States
Metropolitan Hosp Ctr
New York City, New York, 10029
United States
Additional Information:
Study ID Numbers: ACTG 138;
Study Start Date:
Record last reviewed: April 1996
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000653
Other Hiv Infections Studies:
1. A Comparison of SCH 56592 and Fluconazole in the Treatment of Oropharyngeal Candidiasis (OPC) in HIV-Positive Patients
2. A Study of Fluconazole in the Treatment of Cryptococcal Meningitis in Patients with AIDS
3. A Study of Atvogen in Healthy Volunteers and HIV-Infected Patients Who Have No Symptoms of Infection
4. Evaluation of the Changes in HIV-1 Burden in Peripheral Blood and Lymphoid Tissue Following Zidovudine ( AZT ) Treatment in HIV-1-Infected Patients With CD4+ Cells Between 100 and 500 Cells/mm3.
5. A Study of Pentamidine in the Prevention of Pneumocystis Carinii Pneumonia
Related Studies:
Other HIV Infections Clinical Trials
Other New York Clinical Trials
Other Manhasset Clinical Trials
A Trial of Two Doses of 2',3'-Dideoxycytidine (ddC) in the Treatment of Children With Symptomatic HIV Infection Who Are Intolerant of AZT and/or Who Show Progressive Disease While on AZT
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