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A Phase I/II Study of the Safety, Tolerance, and Pharmacokinetics of 9-(2-Phosphonylmethoxyethyl)Adenine ( PMEA; Adefovir ) in Patients With Advanced HIV Disease.

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Adefovir
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, Antiviral Agents, Adenine

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria Concurrent Medication: Allowed: Other antiretroviral therapy IF on a stable dose for at least 4 weeks prior to study entry. Prophylactic therapy with aerosolized pentamidine, oral trimethoprim/sulfamethoxazole (Bactrim, Septra) or dapsone, and fluconazole or ketoconazole IF on a stable prophylactic regimen for at least 4 weeks prior to study entry. Patients must have: HIV seropositivity. Elevated p24 antigen (> 40 pg/ml). Mean CD4 count <= 100 cells/mm3. Life expectancy of at least 3 months. Prior Medication: Allowed: Other prior antiretroviral therapy. Prophylactic therapy with aerosolized pentamidine, oral trimethoprim/sulfamethoxazole (Bactrim, Septra) or dapsone, and fluconazole or ketoconazole. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Inadequate venous access. Active serious infection (other than HIV infection) requiring parenteral antibiotic therapy. Clinically significant cardiac disease, including symptoms of ischemia, congestive heart failure, or arrhythmia. Psychiatric disturbance or illness that may affect compliance. Malignancy other than Kaposi's sarcoma. Concurrent Medication: Excluded: Investigational agents other than stavudine (d4T). Interferon-alpha. Ganciclovir. Foscarnet. Diuretics. Amphotericin B. Aminoglycoside antibiotics. Other nephrotoxic agents. Acyclovir at doses >= 2 g/day. Prior Medication: Excluded within 2 weeks prior to study entry: Investigational agents other than stavudine (d4T). Interferon-alpha. Ganciclovir. Foscarnet. Diuretics. Amphotericin B. Aminoglycoside antibiotics. Other nephrotoxic agents. Excluded within 4 weeks prior to study entry: Systemic therapy for Kaposi's sarcoma. Substance abuse.

Sites / Locations

  • Univ of Washington

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
NCT00002115
Brief Title
A Phase I/II Study of the Safety, Tolerance, and Pharmacokinetics of 9-(2-Phosphonylmethoxyethyl)Adenine ( PMEA; Adefovir ) in Patients With Advanced HIV Disease.
Official Title
A Phase I/II Study of the Safety, Tolerance, and Pharmacokinetics of 9-(2-Phosphonylmethoxyethyl)Adenine ( PMEA; Adefovir ) in Patients With Advanced HIV Disease.
Study Type
Interventional

2. Study Status

Record Verification Date
November 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, pharmacokinetics, and anti-HIV effects of PMEA ( adefovir ) when administered daily by intravenous (IV) and/or subcutaneous (SC) injection in patients with advanced HIV disease.
Detailed Description
Patients receive a single IV or SC dose of PMEA daily for 4 weeks. A maximum tolerated dose will be defined for these regimens.

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, Antiviral Agents, Adenine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Enrollment
20 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Adefovir

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: Other antiretroviral therapy IF on a stable dose for at least 4 weeks prior to study entry. Prophylactic therapy with aerosolized pentamidine, oral trimethoprim/sulfamethoxazole (Bactrim, Septra) or dapsone, and fluconazole or ketoconazole IF on a stable prophylactic regimen for at least 4 weeks prior to study entry. Patients must have: HIV seropositivity. Elevated p24 antigen (> 40 pg/ml). Mean CD4 count <= 100 cells/mm3. Life expectancy of at least 3 months. Prior Medication: Allowed: Other prior antiretroviral therapy. Prophylactic therapy with aerosolized pentamidine, oral trimethoprim/sulfamethoxazole (Bactrim, Septra) or dapsone, and fluconazole or ketoconazole. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Inadequate venous access. Active serious infection (other than HIV infection) requiring parenteral antibiotic therapy. Clinically significant cardiac disease, including symptoms of ischemia, congestive heart failure, or arrhythmia. Psychiatric disturbance or illness that may affect compliance. Malignancy other than Kaposi's sarcoma. Concurrent Medication: Excluded: Investigational agents other than stavudine (d4T). Interferon-alpha. Ganciclovir. Foscarnet. Diuretics. Amphotericin B. Aminoglycoside antibiotics. Other nephrotoxic agents. Acyclovir at doses >= 2 g/day. Prior Medication: Excluded within 2 weeks prior to study entry: Investigational agents other than stavudine (d4T). Interferon-alpha. Ganciclovir. Foscarnet. Diuretics. Amphotericin B. Aminoglycoside antibiotics. Other nephrotoxic agents. Excluded within 4 weeks prior to study entry: Systemic therapy for Kaposi's sarcoma. Substance abuse.
Facility Information:
Facility Name
Univ of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States

12. IPD Sharing Statement

Learn more about this trial

A Phase I/II Study of the Safety, Tolerance, and Pharmacokinetics of 9-(2-Phosphonylmethoxyethyl)Adenine ( PMEA; Adefovir ) in Patients With Advanced HIV Disease.

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