search
Back to results

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

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Adefovir dipivoxil
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Antiviral Agents, Adenine

Eligibility Criteria

1 Day - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • UCSF / Moffitt Hosp - Pediatric
  • Univ of Florida Health Science Ctr / Pediatrics
  • Chicago Children's Memorial Hosp
  • Johns Hopkins Hosp - Pediatric
  • Children's Hosp of Boston
  • Children's Hosp of New Jersey / UMDNJ - New Jersey Med Schl
  • Children's Hosp of Philadelphia
  • Saint Jude Children's Research Hosp of Memphis
  • Vanderbilt Univ Med Ctr
  • Univ of Puerto Rico / Univ Children's Hosp AIDS

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
search

1. Study Identification

Unique Protocol Identification Number
NCT00000843
Brief Title
The Safety and Effectiveness of Adefovir Dipivoxil in HIV-Infected Children
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 1998
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Antiviral Agents, Adenine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Masking
None (Open Label)
Enrollment
24 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Adefovir dipivoxil

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hughes W
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Shenep J
Official's Role
Study Chair
Facility Information:
Facility Name
UCSF / Moffitt Hosp - Pediatric
City
San Francisco
State/Province
California
ZIP/Postal Code
941430105
Country
United States
Facility Name
Univ of Florida Health Science Ctr / Pediatrics
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Chicago Children's Memorial Hosp
City
Chicago
State/Province
Illinois
ZIP/Postal Code
606143394
Country
United States
Facility Name
Johns Hopkins Hosp - Pediatric
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
212874933
Country
United States
Facility Name
Children's Hosp of Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
021155724
Country
United States
Facility Name
Children's Hosp of New Jersey / UMDNJ - New Jersey Med Schl
City
Newark
State/Province
New Jersey
ZIP/Postal Code
071072198
Country
United States
Facility Name
Children's Hosp of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
191044318
Country
United States
Facility Name
Saint Jude Children's Research Hosp of Memphis
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
381052794
Country
United States
Facility Name
Vanderbilt Univ Med Ctr
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
372322581
Country
United States
Facility Name
Univ of Puerto Rico / Univ Children's Hosp AIDS
City
San Juan
ZIP/Postal Code
009365067
Country
Puerto Rico

12. IPD Sharing Statement

Citations:
Citation
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
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs