The Effects of Zidovudine on the Blood of HIV-Infected Patients

This study has been completed.
Sponsor:
Collaborator:
Glaxo Wellcome
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00000965
First received: November 2, 1999
Last updated: February 25, 2011
Last verified: February 2011

November 2, 1999
February 25, 2011
Not Provided
August 1993   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00000965 on ClinicalTrials.gov Archive Site
Not Provided
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The Effects of Zidovudine on the Blood of HIV-Infected Patients
Pharmacokinetics of Total Phosphorylated Zidovudine in Mononuclear Cells From HIV-Infected Patients

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.

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.

Interventional
Not Provided
Primary Purpose: Treatment
HIV Infections
Drug: Zidovudine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
Not Provided
August 1993   (final data collection date for primary outcome measure)

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.

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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.
Both
13 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00000965
ACTG 161
Not Provided
Not Provided
National Institute of Allergy and Infectious Diseases (NIAID)
Glaxo Wellcome
Study Chair: B Stretcher
Study Chair: P Frame
Study Chair: A Pesce
National Institute of Allergy and Infectious Diseases (NIAID)
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP