Completed

Phase Not Applicable

Age: 13Years +

All Genders

ID00000965

Pharmacokinetics of Total Phosphorylated Zidovudine in Mononuclear Cells From HIV-Infected Patients

Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2011-03-01

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

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.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 13Years +

All Genders

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.

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Pharmacokinetics of Total Phosphorylated Zidovudine in Mononuclear Cells From HIV-Infected Patients

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria