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A Study of Dideoxycytidine Plus Zidovudine (AZT) in HIV-Infected Children Who Have Taken 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: Zidovudine (Drug); Zalcitabine (Drug)

Phase: Phase 2

Status: Completed

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

Official(s) and/or principal investigator(s):
S Pahwa, Study Chair
SS Bakshi, Study Chair

Summary

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.

Clinical Details

Official title: A Phase II Study to Evaluate Pharmacokinetics, Safety, Tolerance and Activity of Dideoxycytidine (ddC) Administered in Combination With Zidovudine (AZT) in Stable, AZT-Treated Pediatric Patients With HIV Infection

Study design: Primary Purpose: Treatment

Detailed description: 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

Minimum age: 3 Months. Maximum age: 12 Years. Gender(s): Both.

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.

Locations and Contacts

Univ. Hosp. Ramón Ruiz Arnau, Dept. of Peds., Bayamon 00956, Puerto Rico

San Juan City Hosp. PR NICHD CRS, San Juan 00936, Puerto Rico

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

Long Beach Memorial Med. Ctr., Miller Children's Hosp., Long Beach, California 90801, United States

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

Usc La Nichd Crs, Los Angeles, California 90033, 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

San Francisco Gen. Hosp., San Francisco, California 94110, United States

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

Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases, Torrance, California 90502, United States

Univ. of Connecticut Health Ctr., Dept. of Ped., Farmington, Connecticut 06032, United States

Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease, New Haven, Connecticut 06504, United States

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

Howard Univ. Washington DC NICHD CRS, Washington, District of Columbia 20060, 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 30306, United States

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

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

Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease, Chicago, Illinois 60637, United States

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

Tulane/LSU Maternal/Child CRS, New Orleans, Louisiana 70112, 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

Children's Hospital of Michigan NICHD CRS, Detroit, Michigan 48201, United States

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

St. Joseph's Hosp. & Med. Ctr. of New Jersey, Paterson, New Jersey, United States

Children's Hospital at Albany Medical Center, Dept. of Peds., Albany, New York 12208, United States

Bronx-Lebanon Hosp. IMPAACT CRS, Bronx, New York 10457, 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 11021, United States

Schneider Children's Hosp., Div. of Infectious Diseases, New Hyde Park, New York 11040, United States

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

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

Incarnation Children's Ctr., New York, New York 10032, 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

SUNY Upstate Med. Univ., Dept. of Peds., Syracuse, New York 13210, United States

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

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

The Children's Hosp. of Philadelphia IMPAACT CRS, Philadelphia, Pennsylvania 19104, United States

Med. Univ. of South Carolina, Div. of Ped. Infectious Diseases, Charleston, South Carolina 29425, United States

UW School of Medicine - CHRMC, Seattle, Washington 98105, United States

Additional Information

Click here for more information about Zidovudine

Related publications:

Bakshi SS, Britto P, Capparelli E, Mofenson L, Fowler MG, Rasheed S, Schoenfeld D, Zimmer B, Frank Y, Yogev R, Jimenez E, Salgo M, Boone G, Pahwa SG. Evaluation of pharmacokinetics, safety, tolerance, and activity of combination of zalcitabine and zidovudine in stable, zidovudine-treated pediatric patients with human immunodeficiency virus infection. AIDS Clinical Trials Group Protocol 190 Team. J Infect Dis. 1997 May;175(5):1039-50.

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.


Last updated: March 29, 2012

Page last updated: August 23, 2015

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