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Cytomegalovirus InfectionsPhase 1NCT00000805

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

A Phase 1 study testing Ganciclovir in people with Cytomegalovirus Infections and HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 19 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 14 days to 20 years
Conditions the study is for
Cytomegalovirus Infections, HIV Infections
What is being tested?
Ganciclovir
How many people
32 participants
Where
19 sitesin 2 countries
Study dates
Start not givento Mar 1998
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 days to 20 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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:
Show all 17Show fewer
  • 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.

Who cannot join

  • 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:
Show all 17Show fewer
  • 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.

Trial locations and contacts

19 sites in 2 countries.

19 sites in 2 countries

United States18 sites

  • Univ. of Colorado Denver NICHD CRS

    Aurora, Colorado

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

    Boston, Massachusetts, 02115

  • BMC, Div. of Ped Infectious Diseases

    Boston, Massachusetts

  • Chicago Children's CRS

    Chicago, Illinois, 60614

  • Childrens Hosp. LA - Dept. of Ped., Div. of Clinical Immunology & Allergy

    Los Angeles, California, 90027

  • Usc La Nichd Crs

    Los Angeles, California, 90033

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

    Los Angeles, California, 90095

  • Univ. of Miami Ped. Perinatal HIV/AIDS CRS

    Miami, Florida, 33161

  • Tulane/LSU Maternal/Child CRS

    New Orleans, Louisiana, 70112

  • Columbia IMPAACT CRS

    New York, New York, 10032

  • Incarnation Children's Ctr.

    New York, New York, 10032

  • NYU Med. Ctr., Dept. of Medicine

    New York, New York

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

    Oakland, California, 94609

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

    Paterson, New Jersey

  • St. Christopher's Hosp. for Children

    Philadelphia, Pennsylvania, 19134

  • UCSD Maternal, Child, and Adolescent HIV CRS

    San Diego, California, 92093

  • UW School of Medicine - CHRMC

    Seattle, Washington

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

    Torrance, California, 90502

Other trials in United States

Puerto Rico1 site

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

    San Juan

Other trials in Puerto Rico

About this study

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.

Read the 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.

Being tested
Ganciclovir
Keywords
Ganciclovir, Cytomegalovirus Infections, Acquired Immunodeficiency Syndrome
Medical subject headings
Cytomegalovirus Infections, HIV Infections, Multiple Acyl Coenzyme A Dehydrogenase Deficiency, Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GanciclovirDrug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2001 (estimated)
  2. Study completionMar 1998

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Masking
None (open label)
Enrolment
32 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00000805
Sponsor's protocol ID
ACTG 226
Other IDs
11203
Status last verified
Oct 2021
First submitted
2 Nov 1999
Last updated
3 Nov 2021
Results posted
No

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. doi: 10.1086/317600. Epub 2000 Nov 8.

    PubMed 11069232

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Ganciclovir in people with Cytomegalovirus Infections and HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 19 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00000805, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2021.

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