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

Sponsor:	Gilead Sciences
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00002346

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 I

Study Type:	Interventional
Study Design:	Treatment, Double-Blind, Pharmacokinetics Study
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: AIDS

Drug Information available for: Adenine Adefovir Adefovir dipivoxil

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:

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.

Study ID Numbers:	232B, GS-93-402
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002346 History of Changes
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:

Anti-Infective Agents
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Infection
Antiviral Agents
Pharmacologic Actions
Immunologic Deficiency Syndromes

Reverse Transcriptase Inhibitors
Virus Diseases
Anti-Retroviral Agents
HIV Infections
Therapeutic Uses
Sexually Transmitted Diseases
Lentivirus Infections
Adefovir dipivoxil
Adefovir
Retroviridae Infections
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on November 09, 2009