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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002346
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: March 1995

November 2, 1999
June 23, 2005
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Complete list of historical versions of study NCT00002346 on ClinicalTrials.gov Archive Site
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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
Endpoint Classification: Pharmacokinetics Study
Masking: Double-Blind
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. No abstract available.

*   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.

Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002346
232B, GS-93-402
Not Provided
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Gilead Sciences
Not Provided
Not Provided
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