Search / Trial NCT00002326

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

Launched by GILEAD SCIENCES · Aug 30, 2001

Trial Information

Current as of December 07, 2024

Completed

Keywords

Drug Therapy, Combination Acquired Immunodeficiency Syndrome Aids Related Complex Antiviral Agents Zidovudine Adenine

ClinConnect Summary

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

Gender

ALL

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.

About Gilead Sciences

Gilead Sciences is a leading biopharmaceutical company focused on the discovery, development, and commercialization of innovative medicines to address unmet medical needs. With a strong emphasis on antiviral therapies, particularly for HIV, hepatitis B, hepatitis C, and influenza, Gilead leverages advanced research and development capabilities to drive breakthroughs in treatment and care. The company is committed to improving patient outcomes through rigorous clinical trials, fostering collaborations with healthcare professionals, and engaging in partnerships to enhance global health. Gilead's dedication to scientific excellence and patient-centric approaches positions it at the forefront of the biopharmaceutical industry.

Locations

Bethesda, Maryland, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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