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

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Zidovudine
Zalcitabine
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Zalcitabine, Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Zidovudine

Eligibility Criteria

3 Months - 12 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Long Beach Memorial Med. Ctr., Miller Children's Hosp.
  • Usc La Nichd Crs
  • UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS
  • Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.
  • UCSD Maternal, Child, and Adolescent HIV CRS
  • San Francisco Gen. Hosp.
  • UCSF Pediatric AIDS CRS
  • Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases
  • Univ. of Connecticut Health Ctr., Dept. of Ped.
  • Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease
  • Children's National Med. Ctr., ACTU
  • Howard Univ. Washington DC NICHD CRS
  • Univ. of Miami Ped. Perinatal HIV/AIDS CRS
  • Emory Univ. School of Medicine, Dept. of Peds., Div. of Infectious Diseases
  • Cook County Hosp.
  • Univ. of Illinois College of Medicine at Chicago, Dept. of Peds.
  • Chicago Children's CRS
  • Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease
  • Tulane/LSU Maternal/Child CRS
  • Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology
  • HMS - Children's Hosp. Boston, Div. of Infectious Diseases
  • BMC, Div. of Ped Infectious Diseases
  • Baystate Health, Baystate Med. Ctr.
  • WNE Maternal Pediatric Adolescent AIDS CRS
  • Children's Hospital of Michigan NICHD CRS
  • UMDNJ - Robert Wood Johnson
  • St. Joseph's Hosp. & Med. Ctr. of New Jersey
  • Children's Hospital at Albany Medical Center, Dept. of Peds.
  • Bronx-Lebanon Hosp. IMPAACT CRS
  • SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS
  • North Shore-Long Island Jewish Health System, Dept. of Peds.
  • Schneider Children's Hosp., Div. of Infectious Diseases
  • NYU Med. Ctr., Dept. of Medicine
  • Metropolitan Hosp. NICHD CRS
  • Columbia IMPAACT CRS
  • Incarnation Children's Ctr.
  • Harlem Hosp. Ctr. NY NICHD CRS
  • Univ. of Rochester ACTG CRS
  • SUNY Upstate Med. Univ., Dept. of Peds.
  • DUMC Ped. CRS
  • The Children's Hosp. of Philadelphia IMPAACT CRS
  • St. Christopher's Hosp. for Children
  • Med. Univ. of South Carolina, Div. of Ped. Infectious Diseases
  • UW School of Medicine - CHRMC
  • Univ. Hosp. Ramón Ruiz Arnau, Dept. of Peds.
  • San Juan City Hosp. PR NICHD CRS
  • Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
October 28, 2021
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT00001032
Brief Title
A Study of Dideoxycytidine Plus Zidovudine (AZT) in HIV-Infected Children Who Have Taken AZT
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 Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 1995 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Zalcitabine, Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Zidovudine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
180 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Zidovudine
Intervention Type
Drug
Intervention Name(s)
Zalcitabine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
S Pahwa
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
SS Bakshi
Official's Role
Study Chair
Facility Information:
Facility Name
Long Beach Memorial Med. Ctr., Miller Children's Hosp.
City
Long Beach
State/Province
California
ZIP/Postal Code
90801
Country
United States
Facility Name
Usc La Nichd Crs
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
Facility Name
UCSD Maternal, Child, and Adolescent HIV CRS
City
San Diego
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
San Francisco Gen. Hosp.
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Facility Name
UCSF Pediatric AIDS CRS
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Univ. of Connecticut Health Ctr., Dept. of Ped.
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06032
Country
United States
Facility Name
Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06504
Country
United States
Facility Name
Children's National Med. Ctr., ACTU
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Howard Univ. Washington DC NICHD CRS
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20060
Country
United States
Facility Name
Univ. of Miami Ped. Perinatal HIV/AIDS CRS
City
Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
Facility Name
Emory Univ. School of Medicine, Dept. of Peds., Div. of Infectious Diseases
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30306
Country
United States
Facility Name
Cook County Hosp.
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Univ. of Illinois College of Medicine at Chicago, Dept. of Peds.
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Chicago Children's CRS
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60614
Country
United States
Facility Name
Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Tulane/LSU Maternal/Child CRS
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
HMS - Children's Hosp. Boston, Div. of Infectious Diseases
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
BMC, Div. of Ped Infectious Diseases
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Baystate Health, Baystate Med. Ctr.
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01199
Country
United States
Facility Name
WNE Maternal Pediatric Adolescent AIDS CRS
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Children's Hospital of Michigan NICHD CRS
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
UMDNJ - Robert Wood Johnson
City
New Brunswick
State/Province
New Jersey
Country
United States
Facility Name
St. Joseph's Hosp. & Med. Ctr. of New Jersey
City
Paterson
State/Province
New Jersey
Country
United States
Facility Name
Children's Hospital at Albany Medical Center, Dept. of Peds.
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Bronx-Lebanon Hosp. IMPAACT CRS
City
Bronx
State/Province
New York
ZIP/Postal Code
10457
Country
United States
Facility Name
SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
North Shore-Long Island Jewish Health System, Dept. of Peds.
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
Schneider Children's Hosp., Div. of Infectious Diseases
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Facility Name
NYU Med. Ctr., Dept. of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Metropolitan Hosp. NICHD CRS
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Columbia IMPAACT CRS
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Incarnation Children's Ctr.
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Harlem Hosp. Ctr. NY NICHD CRS
City
New York
State/Province
New York
Country
United States
Facility Name
Univ. of Rochester ACTG CRS
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
SUNY Upstate Med. Univ., Dept. of Peds.
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
DUMC Ped. CRS
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
The Children's Hosp. of Philadelphia IMPAACT CRS
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
St. Christopher's Hosp. for Children
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19134
Country
United States
Facility Name
Med. Univ. of South Carolina, Div. of Ped. Infectious Diseases
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
UW School of Medicine - CHRMC
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
Univ. Hosp. Ramón Ruiz Arnau, Dept. of Peds.
City
Bayamon
ZIP/Postal Code
00956
Country
Puerto Rico
Facility Name
San Juan City Hosp. PR NICHD CRS
City
San Juan
ZIP/Postal Code
00936
Country
Puerto Rico
Facility Name
Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS
City
San Juan
ZIP/Postal Code
00936
Country
Puerto Rico

12. IPD Sharing Statement

Citations:
PubMed Identifier
9129064
Citation
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. doi: 10.1086/520351.
Results Reference
background
PubMed Identifier
21037891
Citation
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.
Results Reference
background

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

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