A Phase I/II Study of the Safety, Tolerance, and Pharmacokinetics of 9-(2-Phosphonylmethoxyethyl)Adenine ( PMEA; Adefovir ) in Patients With Advanced HIV Disease.

June 23, 2005 updated by: Gilead Sciences
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gilead Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

November 1, 1995

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 217A
  • GS-92-202

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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