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Phase I Study of the Safety, Tolerance, and Pharmacokinetics of 9-[2-(Bispivaloyloxymethyl)Phosphonylmethoxyethyl]Adenine (Bis-POM PMEA; Adefovir Dipivoxil) in HIV-Infected Patients

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Adefovir dipivoxil
Sponsored by
Gilead Sciences
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Antiviral Agents, Adenine

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria Concurrent Medication: Allowed: AZT, ddI, or ddC (provided patient has been on a stable regimen for at least 4 weeks prior to study entry). Prophylactic aerosolized pentamidine, fluconazole, ketoconazole, trimethoprim/sulfamethoxazole, or dapsone (provided patient has been on a stable regimen for at least 4 weeks prior to study entry). Patients must have: Documented HIV infection or diagnosis of AIDS. Life expectancy of at least 3 months. Prior Medication: Allowed: Prior AZT, ddI, or ddC. Prophylactic aerosolized pentamidine, fluconazole, ketoconazole, trimethoprim/sulfamethoxazole, or dapsone. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Active, serious infections (other than HIV infections) that require parenteral antibiotic therapy. Clinically significant cardiac disease, including symptoms of ischemia, congestive heart failure, or arrhythmia. Gastrointestinal malabsorption syndrome or inability to receive oral medication. Concurrent Medication: Excluded: Diuretics. Amphotericin B. Aminoglycoside antibiotics. Parenteral antibiotics. Other nephrotoxic agents. Other investigational agents. Non-steroidal anti-inflammatory drugs. Aspirin. Prior Medication: Excluded within 2 weeks prior to study entry: Diuretics. Amphotericin B. Aminoglycoside antibiotics. Parenteral antibiotics. Other nephrotoxic agents. Other investigational agents. Excluded within 3 days prior to study entry: Non-steroidal anti-inflammatory drugs. Aspirin. Active substance abuse (including alcohol or drug abuse).

Sites / Locations

  • Johns Hopkins Univ

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT00002128
Brief Title
Phase I Study of the Safety, Tolerance, and Pharmacokinetics of 9-[2-(Bispivaloyloxymethyl)Phosphonylmethoxyethyl]Adenine (Bis-POM PMEA; Adefovir Dipivoxil) in HIV-Infected Patients
Official Title
Phase I Study of the Safety, Tolerance, and Pharmacokinetics of 9-[2-(Bispivaloyloxymethyl)Phosphonylmethoxyethyl]Adenine (Bis-POM PMEA; Adefovir Dipivoxil) in HIV-Infected Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 1994
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
Gilead Sciences

4. Oversight

5. Study Description

Brief Summary
To study the safety, tolerance, and pharmacokinetics of a single dose of bis-POM PMEA (adefovir dipivoxil) when administered by the oral route in patients with HIV infection.
Detailed Description
Five patients are entered at each of three dose levels of bis-POM PMEA administered orally in a single dose.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Antiviral Agents, Adenine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Enrollment
15 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Adefovir dipivoxil

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Concurrent Medication: Allowed: AZT, ddI, or ddC (provided patient has been on a stable regimen for at least 4 weeks prior to study entry). Prophylactic aerosolized pentamidine, fluconazole, ketoconazole, trimethoprim/sulfamethoxazole, or dapsone (provided patient has been on a stable regimen for at least 4 weeks prior to study entry). Patients must have: Documented HIV infection or diagnosis of AIDS. Life expectancy of at least 3 months. Prior Medication: Allowed: Prior AZT, ddI, or ddC. Prophylactic aerosolized pentamidine, fluconazole, ketoconazole, trimethoprim/sulfamethoxazole, or dapsone. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Active, serious infections (other than HIV infections) that require parenteral antibiotic therapy. Clinically significant cardiac disease, including symptoms of ischemia, congestive heart failure, or arrhythmia. Gastrointestinal malabsorption syndrome or inability to receive oral medication. Concurrent Medication: Excluded: Diuretics. Amphotericin B. Aminoglycoside antibiotics. Parenteral antibiotics. Other nephrotoxic agents. Other investigational agents. Non-steroidal anti-inflammatory drugs. Aspirin. Prior Medication: Excluded within 2 weeks prior to study entry: Diuretics. Amphotericin B. Aminoglycoside antibiotics. Parenteral antibiotics. Other nephrotoxic agents. Other investigational agents. Excluded within 3 days prior to study entry: Non-steroidal anti-inflammatory drugs. Aspirin. Active substance abuse (including alcohol or drug abuse).
Facility Information:
Facility Name
Johns Hopkins Univ
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
8585716
Citation
Cundy KC, Barditch-Crovo P, Walker RE, Collier AC, Ebeling D, Toole J, Jaffe HS. Clinical pharmacokinetics of adefovir in human immunodeficiency virus type 1-infected patients. Antimicrob Agents Chemother. 1995 Nov;39(11):2401-5. doi: 10.1128/AAC.39.11.2401.
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Phase I Study of the Safety, Tolerance, and Pharmacokinetics of 9-[2-(Bispivaloyloxymethyl)Phosphonylmethoxyethyl]Adenine (Bis-POM PMEA; Adefovir Dipivoxil) in HIV-Infected Patients

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