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The Safety and Effectiveness of Zidovudine Plus Adefovir in HIV-Infected Patients

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Adefovir
Zidovudine
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 Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Antiviral Agents, Zidovudine, Adenine

Eligibility Criteria

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

Inclusion Criteria Concurrent Medication: Allowed: Prophylactic therapy with aerosolized pentamidine, oral trimethoprim/sulfamethoxazole (Bactrim, Septra) or dapsone, and fluconazole or ketoconazole IF on a stable regimen for at least 4 weeks prior to study entry. Patients must have: HIV seropositivity. Mean CD4 count <= 500 cells/mm3. Been receiving AZT at 500 mg daily for at least 4 weeks prior to study entry. Life expectancy of at least 3 months. NOTE: Kaposi's sarcoma is permitted provided patient has not received any systemic therapy for KS within the past 4 weeks. Patients with a history of another malignancy must be disease free for 6 months or more prior to study entry. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Inadequate venous access. Active, serious infections (other than HIV infection) requiring parenteral antibiotic therapy. Clinically significant cardiac disease, including symptoms of ischemia, congestive heart failure, or clinically significant arrhythmia. Active malignancy other than Kaposi's sarcoma. Mental incapacity or illness that may affect compliance. Concurrent Medication: Excluded: ddI or ddC. Interferon alpha. Ganciclovir. Foscarnet. Diuretics. Investigational agents including d4T. Chemotherapeutic agents. Amphotericin B. Aminoglycoside antibiotics. Other nephrotoxic agents. Immunomodulatory agents. Parenteral therapy for an active, serious infection (other than HIV infection). Prior Medication: Excluded within 2 weeks prior to study entry: ddI or ddC. Interferon alpha. Ganciclovir. Foscarnet. Diuretics. Investigational agents including d4T. Chemotherapeutic agents. Amphotericin B. Aminoglycoside antibiotics. Other nephrotoxic agents. Immunomodulatory agents. Excluded within 4 weeks prior to study entry: Systemic therapy for Kaposi's sarcoma. Required: AZT at a stable dose for at least 4 weeks prior to study entry. Current use of illicit drugs (e.g., heroin or cocaine). Ingestion of substantial alcohol.

Sites / Locations

  • Natl Cancer Institute

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
NCT00002326
Brief Title
The Safety and Effectiveness of Zidovudine Plus Adefovir in HIV-Infected Patients
Official Title
A Phase I/II Study of the Safety, Tolerance, and Pharmacokinetics of Combination Zidovudine (AZT) and 9-(2-Phosphonylmethoxyethyl)Adenine (PMEA; Adefovir) Treatment in HIV-Infected Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 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 combination zidovudine (AZT) and PMEA (adefovir) therapy.
Detailed Description
Patients receive AZT daily and intravenous PMEA three times weekly for 4 weeks. An MTD will be defined for this regimen.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Antiviral Agents, Zidovudine, 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
Intervention Type
Drug
Intervention Name(s)
Zidovudine

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: Prophylactic therapy with aerosolized pentamidine, oral trimethoprim/sulfamethoxazole (Bactrim, Septra) or dapsone, and fluconazole or ketoconazole IF on a stable regimen for at least 4 weeks prior to study entry. Patients must have: HIV seropositivity. Mean CD4 count <= 500 cells/mm3. Been receiving AZT at 500 mg daily for at least 4 weeks prior to study entry. Life expectancy of at least 3 months. NOTE: Kaposi's sarcoma is permitted provided patient has not received any systemic therapy for KS within the past 4 weeks. Patients with a history of another malignancy must be disease free for 6 months or more prior to study entry. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Inadequate venous access. Active, serious infections (other than HIV infection) requiring parenteral antibiotic therapy. Clinically significant cardiac disease, including symptoms of ischemia, congestive heart failure, or clinically significant arrhythmia. Active malignancy other than Kaposi's sarcoma. Mental incapacity or illness that may affect compliance. Concurrent Medication: Excluded: ddI or ddC. Interferon alpha. Ganciclovir. Foscarnet. Diuretics. Investigational agents including d4T. Chemotherapeutic agents. Amphotericin B. Aminoglycoside antibiotics. Other nephrotoxic agents. Immunomodulatory agents. Parenteral therapy for an active, serious infection (other than HIV infection). Prior Medication: Excluded within 2 weeks prior to study entry: ddI or ddC. Interferon alpha. Ganciclovir. Foscarnet. Diuretics. Investigational agents including d4T. Chemotherapeutic agents. Amphotericin B. Aminoglycoside antibiotics. Other nephrotoxic agents. Immunomodulatory agents. Excluded within 4 weeks prior to study entry: Systemic therapy for Kaposi's sarcoma. Required: AZT at a stable dose for at least 4 weeks prior to study entry. Current use of illicit drugs (e.g., heroin or cocaine). Ingestion of substantial alcohol.
Facility Information:
Facility Name
Natl Cancer Institute
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

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The Safety and Effectiveness of Zidovudine Plus Adefovir in HIV-Infected Patients

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