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

Primary Purpose

HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Zidovudine
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Leukocytes, Mononuclear, Drug Evaluation, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Zidovudine, Phosphorylation

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Univ of Cincinnati

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
February 25, 2011
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Glaxo Wellcome
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1. Study Identification

Unique Protocol Identification Number
NCT00000965
Brief Title
The Effects of Zidovudine on the Blood of HIV-Infected Patients
Official Title
Pharmacokinetics of Total Phosphorylated Zidovudine in Mononuclear Cells From HIV-Infected Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
August 1993 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Glaxo Wellcome

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Leukocytes, Mononuclear, Drug Evaluation, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Zidovudine, Phosphorylation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Enrollment
20 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Zidovudine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
B Stretcher
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
P Frame
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
A Pesce
Official's Role
Study Chair
Facility Information:
Facility Name
Univ of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
452670405
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
8086134
Citation
Stretcher BN, Pesce AJ, Frame PT, Greenberg KA, Stein DS. Correlates of zidovudine phosphorylation with markers of HIV disease progression and drug toxicity. AIDS. 1994 Jun;8(6):763-9. doi: 10.1097/00002030-199406000-00007.
Results Reference
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PubMed Identifier
7586898
Citation
Stretcher BN. Pharmacokinetic optimisation of antiretroviral therapy in patients with HIV infection. Clin Pharmacokinet. 1995 Jul;29(1):46-65. doi: 10.2165/00003088-199529010-00006.
Results Reference
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PubMed Identifier
7979286
Citation
Stretcher BN, Pesce AJ, Frame PT, Stein DS. Pharmacokinetics of zidovudine phosphorylation in peripheral blood mononuclear cells from patients infected with human immunodeficiency virus. Antimicrob Agents Chemother. 1994 Jul;38(7):1541-7. doi: 10.1128/AAC.38.7.1541.
Results Reference
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The Effects of Zidovudine on the Blood of HIV-Infected Patients

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