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HIV InfectionsPhase 1NCT00000685

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

A Phase 1 study testing Zidovudine in people with HIV Infections and Kidney Disease, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV Infections, Kidney Disease
What is being tested?
Zidovudine
How many people
0 participants
Where
2 sitesUnited States
Study dates
Start not givento Feb 1990
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • -
  • 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.

Who cannot join

  • 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.
Show all 46Show fewer
  • 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:
  • Excluded:
  • Treatment for diabetes mellitus.
  • Excluded within 72 hours of study entry:
  • H-2 blockers.
  • Zidovudine (AZT).
  • Excluded within 2 weeks of study entry:
  • Other antiretroviral agents or other experimental therapy.
  • Rifampin or rifampin derivatives.
  • Probenecid.
  • Dilantin.
  • Methadone.
  • Oral contraceptives.
  • Barbiturates.
  • Significant hepatotoxic agents or valproic acid.
  • TMP / SMX.
  • Dapsone.
  • Fansidar.
  • Excluded within 30 days of study entry:
  • Cytotoxic chemotherapy.
  • Prior Treatment:
  • Excluded within 30 days of study entry:
  • Radiation therapy for local mucocutaneous lesions.
  • Risk Behavior:
  • Active drug or alcohol use which might interfere with the study objectives.
  • Note: Alcohol consumption is prohibited 48 hours prior to the first pharmacokinetic study and during the study. Tobacco smoking is not excluded although tobacco use will be quantified.
  • Patients may not have any of the following diseases or symptoms:
  • 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.
  • Diabetes mellitus.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Univ of North Carolina

    Chapel Hill, North Carolina, 275997215

  • Univ of Washington

    Seattle, Washington, 98105

Other trials in United States

About this study

Official title: Evaluation of Zidovudine Pharmacokinetics in Patients With Human Immunodeficiency Virus and Varying Degrees of Renal Insufficiency

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

Read the detailed description

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.

Patients receive AZT by mouth on the first day. After taking the AZT, blood samples are taken from a catheter and several urine samples are collected over a 24-hour period. During this time, patients remain in the hospital for the 24 hours or may choose to go home 12 hours after taking the AZT dose and return for the last blood sample the next morning. Following study day 1, patients receive AZT every 4 hours, including in the middle of the night, and keep a diary of the times they take AZT, as well as of the use of other medications, tobacco, or alcohol. A return appointment is made for 8-15 days later. On that day, patients again receive AZT by mouth, and blood tests and urine samples are again taken. Patients who are receiving hemodialysis participate in 1 additional day of pharmacokinetic studies to be arranged during one hemodialysis session. Patients on Continuous Ambulatory Peritoneal Dialysis (CAPD) are studied separately and do not participate in the procedures for the other groups. AZT is given as a single oral dose at the beginning of the first morning exchange followed by a pharmacokinetic study. Chronic AZT dosing is initiated following the first exchange. After a minimum of 7 days of AZT therapy and a maximum of 14 days the last dose of AZT is administered and a repeat pharmacokinetic study is done. All patients are seen again 1-2 weeks after completing the last pharmacokinetic study.

Being tested
Zidovudine
Keywords
Kidney Diseases, Drug Evaluation, Acquired Immunodeficiency Syndrome, Zidovudine, Renal Dialysis
Medical subject headings
HIV Infections, Kidney Diseases, Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2001 (estimated)
  2. Study completionFeb 1990

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00000685
Sponsor's protocol ID
ACTG 088
Other IDs
NSC 602670, 11063
Status last verified
Oct 2021
First submitted
2 Nov 1999
Last updated
2 Nov 2021
Results posted
No

Publications

  • 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.

    PubMed 2293640

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Zidovudine in people with HIV Infections and Kidney Disease, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 46 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 2 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00000685, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2021.

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