Completed

Phase 2
Age: 3Months - 12Years
All Genders
ID00001032

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

Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2021-11-04

180

Participants Needed

47

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 3Months - 12Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

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.
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

Trial Site Locations

Total: 47 locations

1

Long Beach Memorial Med. Ctr., Miller Children's Hosp.

Long Beach, California, United States, 90801

Status Unknown

2

Usc La Nichd Crs

Los Angeles, California, United States, 90033

Status Unknown

3

UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS

Los Angeles, California, United States

Status Unknown

4

Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.

Oakland, California, United States, 94609

Status Unknown

5

UCSD Maternal, Child, and Adolescent HIV CRS

San Diego, California, United States, 92093

Status Unknown

6

San Francisco Gen. Hosp.

San Francisco, California, United States, 94110

Status Unknown

7

UCSF Pediatric AIDS CRS

San Francisco, California, United States, 94143

Status Unknown

8

Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases

Torrance, California, United States, 90502

Status Unknown

9

Univ. of Connecticut Health Ctr., Dept. of Ped.

Farmington, Connecticut, United States, 06032

Status Unknown

10

Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease

New Haven, Connecticut, United States, 06504

Status Unknown

11

Children's National Med. Ctr., ACTU

Washington D.C., District of Columbia, United States, 20010

Status Unknown

12

Howard Univ. Washington DC NICHD CRS

Washington D.C., District of Columbia, United States, 20060

Status Unknown

13

Univ. of Miami Ped. Perinatal HIV/AIDS CRS

Miami, Florida, United States, 33161

Status Unknown

14

Emory Univ. School of Medicine, Dept. of Peds., Div. of Infectious Diseases

Atlanta, Georgia, United States, 30306

Status Unknown

15

Cook County Hosp.

Chicago, Illinois, United States, 60612

Status Unknown

16

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

Chicago, Illinois, United States, 60612

Status Unknown

17

Chicago Children's CRS

Chicago, Illinois, United States, 60614

Status Unknown

18

Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease

Chicago, Illinois, United States, 60637

Status Unknown

19

Tulane/LSU Maternal/Child CRS

New Orleans, Louisiana, United States, 70112

Status Unknown

20

Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology

Baltimore, Maryland, United States, 21201

Status Unknown

21

HMS - Children's Hosp. Boston, Div. of Infectious Diseases

Boston, Massachusetts, United States, 02115

Status Unknown

22

BMC, Div. of Ped Infectious Diseases

Boston, Massachusetts, United States, 02118

Status Unknown

23

Baystate Health, Baystate Med. Ctr.

Springfield, Massachusetts, United States, 01199

Status Unknown

24

WNE Maternal Pediatric Adolescent AIDS CRS

Worcester, Massachusetts, United States, 01655

Status Unknown

25

Children's Hospital of Michigan NICHD CRS

Detroit, Michigan, United States, 48201

Status Unknown

26

UMDNJ - Robert Wood Johnson

New Brunswick, New Jersey, United States

Status Unknown

27

St. Joseph's Hosp. & Med. Ctr. of New Jersey

Paterson, New Jersey, United States

Status Unknown

28

Children's Hospital at Albany Medical Center, Dept. of Peds.

Albany, New York, United States, 12208

Status Unknown

29

SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS

Brooklyn, New York, United States, 11203

Status Unknown

30

North Shore-Long Island Jewish Health System, Dept. of Peds.

Great Neck, New York, United States, 11021

Status Unknown

31

Schneider Children's Hosp., Div. of Infectious Diseases

New Hyde Park, New York, United States, 11040

Status Unknown

32

NYU Med. Ctr., Dept. of Medicine

New York, New York, United States, 10016

Status Unknown

33

Metropolitan Hosp. NICHD CRS

New York, New York, United States, 10029

Status Unknown

34

Columbia IMPAACT CRS

New York, New York, United States, 10032

Status Unknown

35

Incarnation Children's Ctr.

New York, New York, United States, 10032

Status Unknown

36

Harlem Hosp. Ctr. NY NICHD CRS

New York, New York, United States

Status Unknown

37

Univ. of Rochester ACTG CRS

Rochester, New York, United States, 14642

Status Unknown

38

SUNY Upstate Med. Univ., Dept. of Peds.

Syracuse, New York, United States, 13210

Status Unknown

39

Bronx-Lebanon Hosp. IMPAACT CRS

The Bronx, New York, United States, 10457

Status Unknown

40

DUMC Ped. CRS

Durham, North Carolina, United States, 27710

Status Unknown

41

The Children's Hosp. of Philadelphia IMPAACT CRS

Philadelphia, Pennsylvania, United States, 19104

Status Unknown

42

St. Christopher's Hosp. for Children

Philadelphia, Pennsylvania, United States, 19134

Status Unknown

43

Med. Univ. of South Carolina, Div. of Ped. Infectious Diseases

Charleston, South Carolina, United States, 29425

Status Unknown

44

UW School of Medicine - CHRMC

Seattle, Washington, United States, 98105

Status Unknown

45

Univ. Hosp. Ramón Ruiz Arnau, Dept. of Peds.

Bayamón, Puerto Rico, 00956

Status Unknown

46

San Juan City Hosp. PR NICHD CRS

San Juan, Puerto Rico, 00936

Status Unknown

47

Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS

San Juan, Puerto Rico, 00936

Status Unknown

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

TREATMENT

Number of Arms

0

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Published Research Related To This Trial

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.

S S Bakshi, P Britto, E Capparelli...

https://pubmed.ncbi.nlm.nih.gov/9129064