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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

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ClinicalTrials.gov Identifier: NCT00000805
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : April 2, 2012
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Brief Summary:

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 or disease Intervention/treatment Phase
Cytomegalovirus Infections HIV Infections Drug: Ganciclovir Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 32 participants
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Completion Date : March 1998






Information from the National Library of Medicine

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Ages Eligible for Study:   up to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000805


Locations
Show Show 19 study locations
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
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Study Chair: Frenkel L
Study Chair: Dankner W
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)

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Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00000805    
Other Study ID Numbers: ACTG 226
11203 ( Registry Identifier: DAIDS ES Registry Number )
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: April 2, 2012
Last Verified: March 2012
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Ganciclovir
Cytomegalovirus Infections
Acquired Immunodeficiency Syndrome
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Cytomegalovirus Infections
Virus Diseases
Herpesviridae Infections
DNA Virus Infections
Ganciclovir
Ganciclovir triphosphate
Antiviral Agents
Anti-Infective Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action