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
  Purpose

To study the safety, tolerance, pharmacokinetics, and anti-HIV effects of combination zidovudine (AZT) and PMEA (adefovir) therapy.


Condition Intervention Phase
HIV Infections
Drug: Adefovir
Drug: Zidovudine
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment: 20
Detailed Description:

Patients receive AZT daily and intravenous PMEA three times weekly for 4 weeks. An MTD will be defined for this regimen.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002326

Locations
United States, Maryland
Natl Cancer Institute
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
Gilead Sciences
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00002326     History of Changes
Other Study ID Numbers: 217B, GS-93-204
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Drug Therapy, Combination
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Antiviral Agents
Zidovudine
Adenine

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Zidovudine
Adefovir
Adefovir dipivoxil
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on September 18, 2014