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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00002346
First Posted: August 31, 2001
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
NIH AIDS Clinical Trials Information Service
November 2, 1999
August 31, 2001
December 9, 2005
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No Changes Posted
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The Safety and Effectiveness of Bis-POM PMEA in HIV-Infected Patients
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.
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.
Interventional
Phase 1
Masking: Double
Primary Purpose: Treatment
HIV Infections
Drug: Adefovir dipivoxil
Not Provided
James JS. GS 840 (adefovir dipivoxil): broad-spectrum antiviral trial, CD4 count under 100. AIDS Treat News. 1997 Feb 7;(No 264):4-5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
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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.

Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00002346
232B
GS-93-402
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Gilead Sciences
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NIH AIDS Clinical Trials Information Service
March 1995

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP