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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00002326
First Posted: August 31, 2001
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
NIH AIDS Clinical Trials Information Service
November 2, 1999
August 31, 2001
December 9, 2005
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No Changes Posted
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The Safety and Effectiveness of Zidovudine Plus Adefovir in HIV-Infected Patients
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
To study the safety, tolerance, pharmacokinetics, and anti-HIV effects of combination zidovudine (AZT) and PMEA (adefovir) therapy.
Patients receive AZT daily and intravenous PMEA three times weekly for 4 weeks. An MTD will be defined for this regimen.
Interventional
Phase 1
Primary Purpose: Treatment
HIV Infections
  • Drug: Adefovir
  • Drug: Zidovudine
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
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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.
Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00002326
217B
GS-93-204
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Gilead Sciences
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NIH AIDS Clinical Trials Information Service
October 1995

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP