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A Pharmacokinetic and Tolerance Study of Oral Ganciclovir in HIV-Infected Children With Asymptomatic Cytomegalovirus Infection and Low CD4 Cell Counts or Quiescent Cytomegalovirus Disease
This study is ongoing, but not recruiting participants.
First Received: November 2, 1999   Last Updated: July 11, 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: NCT00000805
  Purpose

PRIMARY: To determine the pharmacokinetics, MTD, and long-term safety and tolerance of oral ganciclovir in HIV-infected infants, children, and adolescents.

SECONDARY: To evaluate the effect of oral ganciclovir on the virologic parameters of CMV.

Maintenance treatment with intravenous (IV) ganciclovir for cytomegalovirus retinitis in AIDS patients is now standard therapy, but daily IV therapy can be complicated by catheter infections and thrombosis. An oral regimen of ganciclovir has been administered safely in adult AIDS patients and may be of significant benefit to children and infants as well.


Condition Intervention Phase
Cytomegalovirus Infections
HIV Infections
Drug: Ganciclovir
Phase I

Study Type: Interventional
Study Design: Treatment, Open Label, Pharmacokinetics Study
Official Title: A Pharmacokinetic and Tolerance Study of Oral Ganciclovir in HIV-Infected Children With Asymptomatic Cytomegalovirus Infection and Low CD4 Cell Counts or Quiescent Cytomegalovirus Disease

Resource links provided by NLM:


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

Estimated Enrollment: 32
Detailed Description:

Maintenance treatment with intravenous (IV) ganciclovir for cytomegalovirus retinitis in AIDS patients is now standard therapy, but daily IV therapy can be complicated by catheter infections and thrombosis. An oral regimen of ganciclovir has been administered safely in adult AIDS patients and may be of significant benefit to children and infants as well.

Patients are assigned to 1 of 5 (PER AMENDMENT 10/24/95, was 4) oral (syrup or capsules) dose levels following a single intravenous dose of ganciclovir. Treatment continues for 72 (PER AMENDMENT 10/24/95, was 24 weeks) weeks after the last patient has been enrolled.

  Eligibility

Ages Eligible for Study:   up to 20 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

Concurrent Medication:

PER AMENDMENT 10/24/95: Allowed:

  • All antiretroviral agents and other medications except those listed under Exclusion - Concurrent Medications.
  • Didanosine. However, patients receiving both drugs (didanosine and ganciclovir) should be monitored for toxicity.
  • Amphotericin B is allowed but requires additional monitoring.

Patients must have:

  • HIV infection.
  • CMV infection.
  • CD4 count < 150 cells/mm3 or < 15 percent AND/OR quiescent CMV disease.
  • NO loss of sight from CMV retinitis.
  • NO acute opportunistic infection.
  • Life expectancy at least to study completion.
  • Consent of parent or guardian.

NOTE:

  • Infants < 6 months of age at enrollment must have been >= 36 weeks gestational age at birth.

NOTE:

  • Patients may co-enroll in other ACTG protocols that do not involve the administration of disallowed medications.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

  • Loss of sight in one eye for any reason, with evidence of CMV retinitis in the other eye.
  • Acute or chronic diarrhea that would affect absorption.
  • Clinical or laboratory toxicities of grade 3 or worse.

Concurrent Medication:

Excluded:

  • Foscarnet.
  • Acyclovir.
  • Interferon.
  • Myelotoxic agents for malignancy or other condition.
  • Other agents with anti-CMV activity. (NOTE:

Enrollment of patients on IVIG must be discussed with protocol chair.)

  • Imipenem/cilastatin sodium.

Prior Medication:

Excluded within 30 days prior to study entry:

  • G-CSF or GM-CSF.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00000805

Locations
United States, California
UCSD Med Ctr / Pediatrics / Clinical Sciences
La Jolla, California, United States, 920930672
Harbor - UCLA Med Ctr / UCLA School of Medicine
Los Angeles, California, United States, 905022004
Children's Hosp of Oakland
Oakland, California, United States, 946091809
UCLA Med Ctr / Pediatric
Los Angeles, California, United States, 900951752
Children's Hosp of Los Angeles/UCLA Med Ctr
Los Angeles, California, United States, 900276016
Los Angeles County - USC Med Ctr
Los Angeles, California, United States, 90033
United States, Colorado
Children's Hosp of Denver
Denver, Colorado, United States, 802181088
United States, Florida
Univ of Miami (Pediatric)
Miami, Florida, United States, 33161
United States, Illinois
Chicago Children's Memorial Hosp
Chicago, Illinois, United States, 606143394
United States, Louisiana
Tulane Univ / Charity Hosp of New Orleans
New Orleans, Louisiana, United States, 701122699
United States, Massachusetts
Children's Hosp of Boston
Boston, Massachusetts, United States, 021155724
United States, New Jersey
Children's Hosp of New Jersey / UMDNJ - New Jersey Med Schl
Newark, New Jersey, United States, 071072198
Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl
Newark, New Jersey, United States, 07103
United States, New York
Columbia Presbyterian Med Ctr
New York, New York, United States, 10032
Incarnation Children's Ctr / Columbia Presbyterian Med Ctr
New York, New York, United States, 10032
United States, Pennsylvania
Saint Christopher's Hosp for Children
Philadelphia, Pennsylvania, United States, 191341095
United States, Texas
Univ of Texas Galveston
Galveston, Texas, United States, 775550435
United States, Washington
Children's Hospital & Medical Center / Seattle ACTU
Seattle, Washington, United States, 981050371
Sponsors and Collaborators
Investigators
Study Chair: Frenkel L
Study Chair: Dankner W
  More Information

Additional Information:
Publications:
Capparelli EV, Frenkel LM, Dankner W, Wei LJ, Xu J, Spector S, Connor J, Ballow A, Mohan K, Robinson C, Shaver A, Rich K, Thompson M, Read J, Wirkus C, Balsley J, Culnane M, Mcintosh K. Population pharmacokinetics of oral and intravenous ganciclovir (GCV) in HIV and CMV infected children. Program Abstr Intersci Conf Antimicrob Agents Chemother. 1996 Sep 15-18:10 (abstract no A51)
Frenkel LM, Dankner W, Capparelli E, Wei LJ, Xu J, Spector S, Connor J, Ballow A, Mohan K, Robinson C, Shaver A, Rich K, Thompson M, Read J, Wirkus C, Balsley J, Culnane M, McIntosh K. A pharmacokinetic (PK) study of oral ganciclovir (GCV) in HIV- and cytomegalovirus (CMV)- infected children. Int Conf AIDS. 1996 Jul 7-12;11(2):31 (abstract no WeB550)
Frenkel LM, Capparelli EV, Dankner WM, Xu J, Smith IL, Ballow A, Culnane M, Read JS, Thompson M, Mohan KM, Shaver A, Robinson CA, Stempien MJ, Burchett SK, Melvin AJ, Borkowsky W, Petru A, Kovacs A, Yogev R, Goldsmith J, McFarland EJ, Spector SA. Oral ganciclovir in children: pharmacokinetics, safety, tolerance, and antiviral effects. The Pediatric AIDS Clinical Trials Group. J Infect Dis. 2000 Dec;182(6):1616-24.

Study ID Numbers: ACTG 226
Study First Received: November 2, 1999
Last Updated: July 11, 2008
ClinicalTrials.gov Identifier: NCT00000805     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Ganciclovir
Cytomegalovirus Infections
Acquired Immunodeficiency Syndrome

Additional relevant MeSH terms:
Anti-Infective Agents
Communicable Diseases
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Immune System Diseases
Acquired Immunodeficiency Syndrome
Ganciclovir
Infection
Antiviral Agents
Pharmacologic Actions
Immunologic Deficiency Syndromes
Herpesviridae Infections
Virus Diseases
HIV Infections
Therapeutic Uses
Sexually Transmitted Diseases
Lentivirus Infections
Cytomegalovirus Infections
DNA Virus Infections
Retroviridae Infections

ClinicalTrials.gov processed this record on November 27, 2009