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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002326
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: October 1995

November 2, 1999
June 23, 2005
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Complete list of historical versions of study NCT00002326 on ClinicalTrials.gov Archive Site
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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
Endpoint Classification: Pharmacokinetics Study
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.
Both
18 Years to 60 Years
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