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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

Information source: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV Infections

Intervention: Zalcitabine (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)

Official(s) and/or principal investigator(s):
Spector SA, Study Chair

Summary

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.

Clinical Details

Official title: 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

Study design: Primary Purpose: Treatment

Detailed description: 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

Minimum age: 3 Months. Maximum age: 18 Years. Gender(s): Both.

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.

Locations and Contacts

Univ. Hosp. Ramón Ruiz Arnau, Dept. of Peds., Bayamon 00619, Puerto Rico

San Juan City Hosp. PR NICHD CRS, San Juan, Puerto Rico

Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS, San Juan 00936, Puerto Rico

UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS, Los Angeles, California 90095, United States

Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab., Oakland, California 94609, United States

UCSD Maternal, Child, and Adolescent HIV CRS, San Diego, California 92093, United States

UCSF Pediatric AIDS CRS, San Francisco, California 94143, United States

Children's National Med. Ctr., ACTU, Washington, District of Columbia 20010, United States

Univ. of Miami Ped. Perinatal HIV/AIDS CRS, Miami, Florida 33161, United States

Emory Univ. School of Medicine, Dept. of Peds., Div. of Infectious Diseases, Atlanta, Georgia 30303, United States

Chicago Children's CRS, Chicago, Illinois 60614, United States

Cook County Hosp., Chicago, Illinois 60612, United States

Univ. of Illinois College of Medicine at Chicago, Dept. of Peds., Chicago, Illinois 60612, 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

Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases, Baltimore, Maryland 21287, United States

Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology, Baltimore, Maryland 21201, United States

BMC, Div. of Ped Infectious Diseases, Boston, Massachusetts 02118, United States

HMS - Children's Hosp. Boston, Div. of Infectious Diseases, Boston, Massachusetts 02115, United States

Baystate Health, Baystate Med. Ctr., Springfield, Massachusetts 01199, United States

WNE Maternal Pediatric Adolescent AIDS CRS, Worcester, Massachusetts 01655, United States

UMDNJ - Robert Wood Johnson, New Brunswick, New Jersey, United States

Bronx-Lebanon Hosp. IMPAACT CRS, Bronx, New York 10456, United States

SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS, Brooklyn, New York 11203, 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 11042, United States

Columbia IMPAACT CRS, New York, New York 10032, United States

Harlem Hosp. Ctr. NY NICHD CRS, New York, New York 10037, United States

Metropolitan Hosp. NICHD CRS, New York, New York 10029, United States

NYU Med. Ctr., Dept. of Medicine, New York, New York 10016, United States

Univ. of Rochester ACTG CRS, Rochester, New York 14642, United States

UNC at Chapel Hill School of Medicine - Dept. of Peds., Div. of Immunology & Infectious Diseases, Chapel Hill, North Carolina 27599, United States

DUMC Ped. CRS, Durham, North Carolina 27710, United States

St. Christopher's Hosp. for Children, Philadelphia, Pennsylvania 19134, United States

Texas Children's Hosp. CRS, Houston, Texas 77030, United States

Additional Information

Click here for more information about Zalcitabine

Related publications:

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)


Last updated: March 29, 2012

Page last updated: August 23, 2015

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