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

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.

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety