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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002346
• Other study ID #: 232B
• Secondary ID: GS-93-402
• Status: Completed
• Phase: Phase 1
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: March 1995
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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.

Study Design

Endpoint Classification: Pharmacokinetics Study, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Adefovir dipivoxil

Locations

Country	Name	City	State
United States	Johns Hopkins Univ	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Country where clinical trial is conducted

United States, 

References & Publications (1)

James JS. GS 840 (adefovir dipivoxil): broad-spectrum antiviral trial, CD4 count under 100. AIDS Treat News. 1997 Feb 7;(No 264):4-5. — View Citation