Retrovir Capsules in the Treatment of HIV-Infected Patients in Renal Failure

NCT00002047 | Completed

• 2 other identifiers: 014H27433-19
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the safety, tolerance, and pharmacokinetics of Retrovir (AZT) administration in HIV-infected patients in renal failure receiving maintenance hemodialysis.

Conditions

HIV Infections; Kidney Failure, Chronic

Keywords

Kidney Failure, Chronic; Acquired Immunodeficiency Syndrome; AIDS-Related Complex; 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:

• Patients must have:
• A positive HIV antibody test (ELISA confirmed by Western blot).
• Chronic renal failure managed by a stable hemodialysis regimen.
• Acceptable hepatic function defined by specified lab values.
• Life expectancy \> 6 months.
• Enrollment is limited to 9 chronic hemodialysis patients and 9 Continuous Ambulatory Peritoneal Dialysis (CAPD) patients. These patients must be stable in their ESRD treatment regimen before entry.

You may not qualify if:

• Co-existing Condition:
• Patients with the following are excluded:
• Active, serious opportunistic infections at the time of study entry.
• Fever \> 100 degrees F at study entry.
• Severe malabsorption (evidenced by persistent diarrhea of greater than 4 weeks duration with = or \> 6 loose stools per day accompanied by significant weight loss).
• Patients with the following are excluded:
• Active, serious opportunistic infections at the time of study entry.
• Fever \> 100 degrees F at study entry.
• Severe malabsorption (evidenced by persistent diarrhea of greater than 4 weeks duration with = or \> 6 loose stools per day accompanied by significant weight loss).
• Prior Medication:
• Excluded within 2 weeks of study entry:
• \- Any other experimental therapy. Drugs which cause significant bone marrow suppression. Rifampin or rifampin derivatives. Cytolytic chemotherapy. Drugs which cause significant hepatotoxicity.
• Excluded within 4 weeks of study entry:
• \- Immunomodulating agents, including steroids, interferon, Isoprinosine, and interleukin 2.
• Excluded within 8 weeks of study entry:

Sponsors & Collaborators

• Glaxo Wellcome: lead

Study Sites (1)

Univ of Maryland at Baltimore

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

HIV Infections; Kidney Failure, Chronic; Acquired Immunodeficiency Syndrome; AIDS-Related Complex

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; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; 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 Design

• Study Type: interventional
• Phase: not applicable
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Last Updated: June 24, 2005

Record last verified: 1990-05

Locations

US (1)