ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
A Phase I/II Study of the Safety, Tolerance, and Pharmacokinetics of 9-(2-Phosphonylmethoxyethyl)Adenine ( PMEA; Adefovir ) in Patients With Advanced HIV Disease.

This study has been completed.

Sponsored by: Gilead Sciences
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002115
  Purpose

To study the safety, tolerance, pharmacokinetics, and anti-HIV effects of PMEA ( adefovir ) when administered daily by intravenous (IV) and/or subcutaneous (SC) injection in patients with advanced HIV disease.


Condition Intervention Phase
HIV Infections
Drug: Adefovir
Phase I

MedlinePlus related topics:   AIDS   

Drug Information available for:   Adefovir dipivoxil    Adefovir    Adenine   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Dose Comparison, Pharmacokinetics Study
Official Title:   A Phase I/II Study of the Safety, Tolerance, and Pharmacokinetics of 9-(2-Phosphonylmethoxyethyl)Adenine ( PMEA; Adefovir ) in Patients With Advanced HIV Disease.

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment:   20

Detailed Description:

Patients receive a single IV or SC dose of PMEA daily for 4 weeks. A maximum tolerated dose will be defined for these regimens.

  Eligibility
Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria

Concurrent Medication:

Allowed:

  • Other antiretroviral therapy IF on a stable dose for at least 4 weeks prior to study entry.
  • Prophylactic therapy with aerosolized pentamidine, oral trimethoprim/sulfamethoxazole (Bactrim, Septra) or dapsone, and fluconazole or ketoconazole IF on a stable prophylactic regimen for at least 4 weeks prior to study entry.

Patients must have:

  • HIV seropositivity.
  • Elevated p24 antigen (> 40 pg/ml).
  • Mean CD4 count <= 100 cells/mm3.
  • Life expectancy of at least 3 months.

Prior Medication:

Allowed:

  • Other prior antiretroviral therapy.
  • Prophylactic therapy with aerosolized pentamidine, oral trimethoprim/sulfamethoxazole (Bactrim, Septra) or dapsone, and fluconazole or ketoconazole.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

  • Inadequate venous access.
  • Active serious infection (other than HIV infection) requiring parenteral antibiotic therapy.
  • Clinically significant cardiac disease, including symptoms of ischemia, congestive heart failure, or arrhythmia.
  • Psychiatric disturbance or illness that may affect compliance.
  • Malignancy other than Kaposi's sarcoma.

Concurrent Medication:

Excluded:

  • Investigational agents other than stavudine (d4T).
  • Interferon-alpha.
  • Ganciclovir.
  • Foscarnet.
  • Diuretics.
  • Amphotericin B.
  • Aminoglycoside antibiotics.
  • Other nephrotoxic agents.
  • Acyclovir at doses >= 2 g/day.

Prior Medication:

Excluded within 2 weeks prior to study entry:

  • Investigational agents other than stavudine (d4T).
  • Interferon-alpha.
  • Ganciclovir.
  • Foscarnet.
  • Diuretics.
  • Amphotericin B.
  • Aminoglycoside antibiotics.
  • Other nephrotoxic agents.

Excluded within 4 weeks prior to study entry:

  • Systemic therapy for Kaposi's sarcoma. Substance abuse.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002115

Locations
United States, Washington
Univ of Washington    
      Seattle, Washington, United States, 98122

Sponsors and Collaborators
Gilead Sciences
  More Information


Study ID Numbers:   217A, GS-92-202
First Received:   November 2, 1999
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00002115
Health Authority:   United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Acquired Immunodeficiency Syndrome  
Antiviral Agents  
Adenine  

Study placed in the following topic categories:
Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Adefovir dipivoxil
Adefovir
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
Anti-Infective Agents
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Infection
Antiviral Agents
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Lentivirus Infections
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on December 03, 2008




Links to all studies - primarily for crawlers