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The Safety and Effectiveness of Adefovir Dipivoxil in HIV-Infected Children

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00000843
First Posted: August 31, 2001
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
  Purpose

To evaluate the single-dose pharmacokinetic profile and acute toxicity of bis-POM PMEA ( adefovir dipivoxil ) in HIV-1 infected children, and to determine whether age-related differences exist. To ascertain dosages that may be suitable for a multiple-dose evaluation in this patient population.

Although the oral bioavailability of PMEA ( adefovir ) is low, the prodrug bis-POM PMEA has resulted in increased bioavailability in adult patients in clinical trials. However, the safety and pharmacokinetic patterns of drugs in infants often differ from those of adults and the direction of the variation is not predictable. This study will assess these parameters of bis-POM PMEA in children.


Condition Intervention Phase
HIV Infections Drug: Adefovir dipivoxil Phase 1

Study Type: Interventional
Study Design: Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase IA Single Dose Pharmacokinetics and Safety Study of the Oral Antiviral Compound, 9-[2-(Bispivaloyloxymethyl)Phosphonylmethoxyethyl]Adenine (Bis-POM PMEA) (Adefovir Dipivoxil) in Children With HIV-1 Infection

Resource links provided by NLM:


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

Estimated Enrollment: 24
Detailed Description:

Although the oral bioavailability of PMEA ( adefovir ) is low, the prodrug bis-POM PMEA has resulted in increased bioavailability in adult patients in clinical trials. However, the safety and pharmacokinetic patterns of drugs in infants often differ from those of adults and the direction of the variation is not predictable. This study will assess these parameters of bis-POM PMEA in children.

Patients are stratified by age, and separate cohorts from each age group receive 1 of 2 single doses of bis-POM PMEA. The lower dose is given to patients ages 3 months through 17 years; if toxicity is acceptable, the other cohort in this age range receives the higher dose. At this point, accrual of infants < 3 months old may begin at the lower dose, followed by accrual of this age group at the higher dose if toxicity is acceptable. Serum drug concentrations are monitored up to 8 hours post dose.

AS PER AMENDMENT 5/2/97: Based on data from both the low- and high-dose cohorts of the older age group (>= 3 months to < 18 years), the younger age group (<3 months) will be started at the high-dose.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

Patients must have:

  • Asymptomatic or mildly symptomatic HIV infection, with no worse than grade 1 toxicity for any symptoms.
  • Consent of parent or guardian.

Prior Medication:

Allowed:

  • IV gammaglobulin and aerosolized pentamidine for PCP prophylaxis.
  • Antiretrovirals if discontinued by 72 hr prior to study entry.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

  • Acute or chronic infections that require treatment during study.

Concurrent Medication:

Excluded:

  • Antiretrovirals other than study drug.
  • Other investigational agents.
  • Immunomodulators.
  • HIV-1 vaccines.
  • Glucocorticoids.
  • Drugs with potential for adverse interaction with study drug or that would interfere with quantitation of study drug in serum or plasma.
  • TMP / SMX and dapsone.

PER AMENDMENT 8/23/96:

  • Drugs which may affect renal excretion:
  • Probenecid, Acyclovir, Ganciclovir, Foscarnet, Amphotericin B and Pentamidine.

Prior Medication:

Excluded within 72 hr prior to study entry:

  • Antiretrovirals other than study drug.
  • Other investigational agents.
  • Immunomodulators.
  • HIV-1 vaccines.
  • Glucocorticoids.
  • Drugs with potential for adverse interaction with study drug or that would interfere with quantitation of study drug in serum or plasma.
  • TMP / SMX and dapsone.

PER AMENDMENT 8/23/96:

  • Drugs which may affect renal excretion:
  • Probenecid, Acyclovir, Ganciclovir, Foscarnet, Amphotericin B and Pentamidine.
  Contacts and Locations
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): NCT00000843


Locations
United States, California
UCSF / Moffitt Hosp - Pediatric
San Francisco, California, United States, 941430105
United States, Florida
Univ of Florida Health Science Ctr / Pediatrics
Jacksonville, Florida, United States, 32209
United States, Illinois
Chicago Children's Memorial Hosp
Chicago, Illinois, United States, 606143394
United States, Maryland
Johns Hopkins Hosp - Pediatric
Baltimore, Maryland, United States, 212874933
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
United States, Pennsylvania
Children's Hosp of Philadelphia
Philadelphia, Pennsylvania, United States, 191044318
United States, Tennessee
Saint Jude Children's Research Hosp of Memphis
Memphis, Tennessee, United States, 381052794
Vanderbilt Univ Med Ctr
Nashville, Tennessee, United States, 372322581
Puerto Rico
Univ of Puerto Rico / Univ Children's Hosp AIDS
San Juan, Puerto Rico, 009365067
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Study Chair: Hughes W
Study Chair: Shenep J
  More Information

Publications:
McKinney RE Jr. Ongoing and future trials of antiretroviral therapy in the pediatric AIDS clinical trials group (PACTG). Conf Retroviruses Opportunistic Infect. 1996 Jan 28-Feb 1;3rd:173

ClinicalTrials.gov Identifier: NCT00000843     History of Changes
Other Study ID Numbers: ACTG 310
First Submitted: November 2, 1999
First Posted: August 31, 2001
Last Update Posted: December 9, 2005
Last Verified: April 1998

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Antiviral Agents
Adenine

Additional relevant MeSH terms:
Infection
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Adefovir
Adefovir dipivoxil
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents