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
NCT ID: NCT00000653
Last Updated: 2021-10-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
140 participants
INTERVENTIONAL
1995-06-30
Brief Summary
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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.
Detailed Description
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Patients receive oral ddC for 48 to 177 weeks.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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Zalcitabine
Eligibility Criteria
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Inclusion Criteria
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
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.
3 Months
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Spector SA
Role: STUDY_CHAIR
Locations
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UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS
Los Angeles, California, United States
Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.
Oakland, California, United States
UCSD Maternal, Child, and Adolescent HIV CRS
San Diego, California, United States
UCSF Pediatric AIDS CRS
San Francisco, California, United States
Children's National Med. Ctr., ACTU
Washington D.C., District of Columbia, United States
Univ. of Miami Ped. Perinatal HIV/AIDS CRS
Miami, Florida, United States
Emory Univ. School of Medicine, Dept. of Peds., Div. of Infectious Diseases
Atlanta, Georgia, United States
Cook County Hosp.
Chicago, Illinois, United States
Univ. of Illinois College of Medicine at Chicago, Dept. of Peds.
Chicago, Illinois, United States
Chicago Children's CRS
Chicago, Illinois, United States
Tulane Med. Ctr. - Charity Hosp. of New Orleans, ACTU
New Orleans, Louisiana, United States
Tulane/LSU Maternal/Child CRS
New Orleans, Louisiana, United States
Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology
Baltimore, Maryland, United States
Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases
Baltimore, Maryland, United States
HMS - Children's Hosp. Boston, Div. of Infectious Diseases
Boston, Massachusetts, United States
BMC, Div. of Ped Infectious Diseases
Boston, Massachusetts, United States
Baystate Health, Baystate Med. Ctr.
Springfield, Massachusetts, United States
WNE Maternal Pediatric Adolescent AIDS CRS
Worcester, Massachusetts, United States
UMDNJ - Robert Wood Johnson
New Brunswick, New Jersey, United States
SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS
Brooklyn, New York, United States
North Shore-Long Island Jewish Health System, Dept. of Peds.
Great Neck, New York, United States
Schneider Children's Hosp., Div. of Infectious Diseases
New Hyde Park, New York, United States
NYU Med. Ctr., Dept. of Medicine
New York, New York, United States
Metropolitan Hosp. NICHD CRS
New York, New York, United States
Columbia IMPAACT CRS
New York, New York, United States
Harlem Hosp. Ctr. NY NICHD CRS
New York, New York, United States
Univ. of Rochester ACTG CRS
Rochester, New York, United States
Bronx-Lebanon Hosp. IMPAACT CRS
The Bronx, New York, United States
UNC at Chapel Hill School of Medicine - Dept. of Peds., Div. of Immunology & Infectious Diseases
Chapel Hill, North Carolina, United States
DUMC Ped. CRS
Durham, North Carolina, United States
St. Christopher's Hosp. for Children
Philadelphia, Pennsylvania, United States
Texas Children's Hosp. CRS
Houston, Texas, United States
Univ. Hosp. Ramón Ruiz Arnau, Dept. of Peds.
Bayamón, , Puerto Rico
Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS
San Juan, , Puerto Rico
San Juan City Hosp. PR NICHD CRS
San Juan, , Puerto Rico
Countries
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References
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Perrier M, Schwarz T, Gonzalez O, Brounts S. Squamous cell carcinoma invading the right temporomandibular joint in a Belgian mare. Can Vet J. 2010 Aug;51(8):885-7.
Spector SA, Blanchard S, Connor EM, Salgo MP, McNamara J. Results of a clinical trial comparing two doses of 2'3'-dideoxycytidine (ddC) in the treatment of children with symptomatic human immunodeficiency virus (HIV) infection who were intolerant or had failed zidovudine (ZDV) therapy (ACTG 138). The Pediatric AIDS Clinical Trials Group. American Pediatric Society 104th annual meeting and Society for Pediatric Research 63rd annual meeting; 1994 May 2-5; Seattle. Pediatr AIDS HIV Infect. 1994 Oct;5(5):323 (unnumbered abstract)
Other Identifiers
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11113
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACTG 138
Identifier Type: -
Identifier Source: org_study_id