Overview

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

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator:
Glaxo Wellcome
Treatments:
Zidovudine
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.