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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
History of Changes
  Purpose

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.


Condition Intervention Phase
HIV Infections
 Drug: Adefovir dipivoxil
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

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

Estimated Enrollment: 36
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.

  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:

  • 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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002346

Locations
United States, Maryland
Johns Hopkins Univ
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Gilead Sciences
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00002346     History of Changes
Other Study ID Numbers: 232B, GS-93-402
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
 Adefovir
Adefovir dipivoxil
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents

ClinicalTrials.gov processed this record on May 23, 2013