A Study of Zidovudine in HIV-Infected Patients With Kidney Problems

NCT00000685 | Withdrawn Phase 1

• 3 other identifiers: ACTG 088NSC 60267011063
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

To determine how zidovudine (AZT) for the treatment of HIV infection is metabolized and excreted or eliminated in patients with infected or diseased kidneys. To determine the influence of hemodialysis and establish dose guidelines. AZT is the only antiviral agent with demonstrated effectiveness in patients with severe HIV infection. Persons with HIV infection may have additional health problems, one of which is a diseased kidney due to infection of the kidney, or side effects of therapy. The benefits and risks of AZT in patients with diseased kidneys are unknown. It is hoped that this study will allow further understanding of the metabolism and excretion of AZT in patients with kidney disease. AZT pharmacokinetics will be studied in patients with mild, moderate, and severe renal disorders

Conditions

HIV Infections; Kidney Disease

Keywords

Kidney Diseases; Drug Evaluation; Acquired Immunodeficiency Syndrome; Zidovudine; Renal Dialysis

Interventions

Zidovudine DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Concurrent Medication:
• Allowed:
• Symptomatic therapy such as analgesics, antihistamines, antiemetics, antidiarrheal agents, or other supportive therapy.
• Aerosolized pentamidine.
• Discouraged:
• \- Sucralfate or antacids. However if these medications are essential for the patient's management, they should not be given within 8 hours before or 2 hours after the scheduled pharmacokinetic study.
• Concurrent Treatment:
• Allowed:
• Blood transfusions.
• Patients must have HIV infection with renal insufficiency and acceptable hepatic and hematologic function. They must have been on dialysis treatment for at least 3 months.
• Prior Medication:
• Allowed:
• Cytotoxic chemotherapy for local mucocutaneous lesions.
• Aerosolized pentamidine.

You may not qualify if:

• Concurrent Medication:
• Excluded:
• Ongoing therapy for opportunistic infections, including systemic maintenance therapy which cannot be discontinued for the duration of the study, such as amphotericin B or ganciclovir.
• H-2 blockers.
• Zidovudine (AZT).
• Other antiretroviral agents or other experimental therapy.
• Discouraged:
• \- Sucralfate or antacids. However, if these medications are essential for the patient's management, they should not be given within 8 hours before or 2 hours after the scheduled pharmacokinetic study.
• Patients will be excluded from the study for the following reasons:
• Presence of active opportunistic infections.
• Severe malabsorption syndrome (persistent diarrhea greater than 4 weeks duration with = or \> 4 loose stools per day accompanied by = or \> 10 percent unintentional weight loss.
• Acute illness, febrile or unstable, 48 hours prior to the first pharmacokinetic study.
• Known sensitivity to zidovudine or thymidine-type agents.
• Diabetes mellitus requiring treatment.
• Prior Medication:

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (2)

Univ of North Carolina

Chapel Hill, North Carolina, 275997215, United States

Location

Univ of Washington

Seattle, Washington, 98105, United States

Location

Related Publications (1)

• Tartaglione TA, Holeman E, Opheim K, Smith T, Collier AC. Zidovudine disposition during hemodialysis in a patient with acquired immunodeficiency syndrome. J Acquir Immune Defic Syndr (1988). 1990;3(1):32-4.

  PMID: 2293640 BACKGROUND

MeSH Terms

Conditions

HIV Infections; Kidney Diseases; Acquired Immunodeficiency Syndrome

Interventions

Zidovudine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Male Urogenital Diseases; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Thymidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dideoxynucleosides; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Tartaglione TA

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Study Completion: February 1, 1990
• Last Updated: November 2, 2021

Record last verified: 2021-10

Locations

US (2)