The Effects of Zidovudine on the Blood of HIV-Infected Patients
Information source: National Institute of Allergy and Infectious Diseases (NIAID)
Information obtained from ClinicalTrials.gov on March 21, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections
Intervention: Zidovudine (Drug)
Phase: N/A
Status: Completed
Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID) Official(s) and/or principal investigator(s):
B Stretcher, Study Chair
P Frame, Study Chair
A Pesce, Study Chair
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.
Clinical Details
Official title: Pharmacokinetics of Total Phosphorylated Zidovudine in Mononuclear Cells From HIV-Infected Patients
Study design: Treatment
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
Minimum age: 13 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Univ of Cincinnati, Cincinnati, Ohio 452670405, United States
Additional Information
Click here for more information about Zidovudine
Related publications: 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. Stretcher BN. Pharmacokinetic optimisation of antiretroviral therapy in patients with HIV infection. Clin Pharmacokinet. 1995 Jul;29(1):46-65. Review. 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.
Last updated: June 23, 2005
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