The Safety and Effectiveness of Bis-POM PMEA in HIV-Infected Patients

June 23, 2005 updated by: Gilead Sciences

A Phase I/II Study of Safety, Tolerance, Pharmacokinetics, and Anti-HIV Activity of 9-[2-(Bispivaloyloxymethyl)Phosphonylmethoxyethyl]Adenine (Bis-POM PMEA) and Placebo in HIV-Infected Patients

To study the safety, tolerance, single and multiple dose pharmacokinetics, and anti-HIV activity of bis-POM PMEA ( adefovir dipivoxil ) versus placebo when administered orally on a daily basis for 2 weeks to HIV-infected patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients are randomized to receive bis-POM PMEA at one of three fixed dose levels or placebo daily for 2 weeks. At each dose level, nine patients receive bis-POM PMEA and three patients receive placebo.

Study Type

Interventional

Enrollment

36

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
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins Univ

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:

  • Prophylaxis with aerosolized pentamidine, fluconazole, ketoconazole, trimethoprim/sulfamethoxazole, or dapsone, provided a stable regimen has been maintained for at least 4 weeks prior to study entry.

Patients must have:

  • HIV seropositivity.
  • CD4 count >= 100 cells/mm3.
  • p24 antigen (immune-complex dissociated) >= 50 pg/ml.
  • Life expectancy of at least 6 months.

Prior Medication:

Allowed:

  • Prior prophylaxis with aerosolized pentamidine, fluconazole, ketoconazole, trimethoprim/sulfamethoxazole, or dapsone.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

  • Active, serious infection (other than HIV infection) requiring parenteral antibiotic therapy.
  • Malignancy other than cutaneous Kaposi's sarcoma.
  • Clinically significant cardiac disease, including symptoms of ischemia, congestive heart failure, or arrhythmia.
  • Gastrointestinal malabsorption syndrome.
  • Inability to take oral medication.

Concurrent Medication:

Excluded:

  • Any parenteral antibiotic therapy.
  • Diuretics.
  • Amphotericin B.
  • Didanosine (ddI).
  • Fluconazole.
  • Foscarnet.
  • Ganciclovir.
  • Interferon-alpha.
  • Interferon-beta.
  • Isoniazid.
  • Aminoglycoside antibiotics.
  • Ketoconazole (topical allowed).
  • Itraconazole.
  • Rifabutin.
  • Rifampin.
  • Stavudine (d4T).
  • Zalcitabine (ddC).
  • Zidovudine (AZT).
  • Lamivudine (3TC).
  • Any investigational agents (except with sponsor approval).
  • Systemic therapy for Kaposi's sarcoma.

Patients with the following prior condition are excluded:

History of lactose intolerance.

Prior Medication:

Excluded within 2 weeks prior to study entry:

  • Any parenteral antibiotic therapy.
  • Diuretics.
  • Amphotericin B.
  • Didanosine (ddI).
  • Fluconazole.
  • Foscarnet.
  • Ganciclovir.
  • Interferon-alpha.
  • Interferon-beta.
  • Isoniazid.
  • Aminoglycoside antibiotics.
  • Ketoconazole (topical allowed).
  • Itraconazole.
  • Rifabutin.
  • Rifampin.
  • Stavudine (d4T).
  • Zalcitabine (ddC).
  • Zidovudine (AZT).
  • Lamivudine (3TC).
  • Any investigational agents (except with sponsor approval).

Excluded within 4 weeks prior to study entry:

Systemic therapy for Kaposi's sarcoma. Active substance abuse (including alcohol) as determined by questionnaire or positive drug screen.

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
  • Masking: Double

Collaborators and Investigators

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

Sponsor

Gilead Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

March 1, 1995

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 232B
  • GS-93-402

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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