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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00002346

Enrollment

Registered

2001-08-31

Start date

Unknown

Completion date

Unknown

Last updated

2005-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Antiviral Agents, Adenine

Brief summary

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.

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.

Interventions

DRUGAdefovir dipivoxil

Study design

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026