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A Study of Dideoxycytidine Plus Zidovudine (AZT) in HIV-Infected Children Who Have Taken AZT
This study has been completed.
First Received: November 2, 1999   Last Updated: August 18, 2008   History of Changes
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00001032
  Purpose

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.


Condition Intervention Phase
HIV Infections
Drug: Zidovudine
Drug: Zalcitabine
Phase II

Study Type: Interventional
Study Design: Treatment
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

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 180
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

Ages Eligible for Study:   3 Months to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00001032

  Show 61 Study Locations
Sponsors and Collaborators
Investigators
Study Chair: S Pahwa
Study Chair: SS Bakshi
  More Information

Additional Information:
Publications:
Study ID Numbers: ACTG 190
Study First Received: November 2, 1999
Last Updated: August 18, 2008
ClinicalTrials.gov Identifier: NCT00001032     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Zalcitabine
Drug Therapy, Combination
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Zidovudine

Additional relevant MeSH terms:
Antimetabolites
Communicable Diseases
Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Zidovudine
Infection
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Retroviridae Infections
Nucleic Acid Synthesis Inhibitors
RNA Virus Infections
Anti-HIV Agents
Immune System Diseases
Acquired Immunodeficiency Syndrome
Zalcitabine
Enzyme Inhibitors
Antiviral Agents
Immunologic Deficiency Syndromes
Pharmacologic Actions
Virus Diseases
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections

ClinicalTrials.gov processed this record on November 09, 2009