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

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Adefovir dipivoxil
Sponsored by
Gilead Sciences
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Antiviral Agents, Adenine

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

  • Johns Hopkins Univ

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT00002346
Brief Title
The Safety and Effectiveness of Bis-POM PMEA in HIV-Infected Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 1995
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Gilead Sciences

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Antiviral Agents, Adenine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Masking
Double
Enrollment
36 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Adefovir dipivoxil

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Johns Hopkins Univ
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
11364103
Citation
James JS. GS 840 (adefovir dipivoxil): broad-spectrum antiviral trial, CD4 count under 100. AIDS Treat News. 1997 Feb 7;(No 264):4-5.
Results Reference
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The Safety and Effectiveness of Bis-POM PMEA in HIV-Infected Patients

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