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The Effects of Zidovudine on the Blood of HIV-Infected Patients
This study has been completed.
Sponsors and Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
Glaxo Wellcome
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00000965
  Purpose

To define the pharmacokinetic parameters (blood levels) of total phosphorylated zidovudine (AZT) in peripheral blood mononuclear cells (PBMC) from HIV-infected patients.

Despite an understanding of the serum (or plasma) pharmacokinetics (blood levels) of AZT, a therapeutic concentration range and optimal dosing interval have not yet been determined.


Condition Intervention
HIV Infections
Drug: Zidovudine

MedlinePlus related topics: AIDS
Drug Information available for: Zidovudine
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: Pharmacokinetics of Total Phosphorylated Zidovudine in Mononuclear Cells From HIV-Infected Patients

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 20
Detailed Description:

Despite an understanding of the serum (or plasma) pharmacokinetics (blood levels) of AZT, a therapeutic concentration range and optimal dosing interval have not yet been determined.

Three studies are planned on two separate patient groups. Group (1) Patients who have never taken AZT start on a standard dose of AZT. Blood samples are taken hourly for an 8-hour period on days 1 and 14. Other blood samples are taken on days 2, 4, and 8. Group (2) Patients who have never taken AZT are given a standard dose for the first week, increasing each week until week 5. Blood samples are taken at the end of each weekly treatment. After 4 weeks of standard treatment, patients in groups 1 and 2 return and receive a single morning dose of oral AZT. Blood samples are taken immediately before dosing and at 1, 2, 4, 6, and 8 hours after dosing. After a 48-hour clearance period, patients return and resume dosing. Blood samples are again taken over an 8-hour period. After 24 weeks of standard treatment, the pharmacokinetic studies are repeated.

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

Concurrent Medication:

Allowed:

  • FDA-approved anti-pneumocystis and antifungal prophylactic or suppressive regimens.
  • Acyclovir for up to 3 weeks intermittently.

Patients must:

  • Meet current guidelines for receiving prescription zidovudine.
  • Have written informed consent from both subject and parent or guardian if under 18. Be capable of understanding and giving informed consent. Women and minorities are actively encouraged to participate.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

  • Malabsorption syndrome (3 or more loose stools/day for at least 4 weeks associated with unintentional weight loss of greater than 10 percent of body weight).

Concurrent Medication:

Excluded:

  • Probenecid or non-FDA approved investigational drugs.
  • Systemic chemotherapy.
  • Other antiviral agents, licensed or investigational, including ganciclovir, foscarnet, ribavirin, didanosine (ddI), dideoxycytidine (ddC), and dideoxydidehydrothymidine (D4T).

Chronic acyclovir.

-

Patients with the following are excluded:

  • Active bacterial, fungal, or viral infection requiring systemic therapy not specifically allowed.
  • Significant, chronic medical conditions that could impair compliance with study treatment.

Prior Medication:

Excluded:

  • Zidovudine (AZT).
  • Systemic chemotherapy within previous 6 months.
  • Acyclovir within 30 days of study entry.

Risk Behavior:

Excluded:

  • Unable to take oral medication reliably.
  • Alcohol or drug abuse that could impair compliance with study treatment.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00000965

Locations
United States, Ohio
Univ of Cincinnati
Cincinnati, Ohio, United States, 452670405
Sponsors and Collaborators
Glaxo Wellcome
Investigators
Study Chair: B Stretcher
Study Chair: P Frame
Study Chair: A Pesce
  More Information

Click here for more information about Zidovudine  This link exits the ClinicalTrials.gov site

Publications:
Study ID Numbers: ACTG 161
Study First Received: November 2, 1999
Last Updated: August 25, 2008
ClinicalTrials.gov Identifier: NCT00000965  
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Leukocytes, Mononuclear
Drug Evaluation
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Zidovudine
Phosphorylation

Study placed in the following topic categories:
Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Zidovudine
AIDS-Related Complex
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
RNA Virus Infections
Anti-HIV Agents
Slow Virus Diseases
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Infection
Antiviral Agents
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Lentivirus Infections
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on January 15, 2009