The Effects of Valproic Acid on Zidovudine Glucuronidation and Pharmacokinetics in HIV-Infected Patients.

Inclusion Criteria

Concurrent Medication:

Allowed:

Vitamins if already being taken prior to start of therapy.

Patients must have:

• Asymptomatic HIV infection.
• CD4 count between 300 and 650.

Prior Medication:

Required:

• AZT at doses between 500 and 1200 mg/day for at least 6 weeks prior to enrollment.

Allowed:

• Aspirin, Tylenol, or ibuprofen up to 48 hours prior to start of therapy.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

• Positive Hepatitis B surface antigen or clinical evidence of chronic active hepatitis of any type.
• Signs or symptoms of HIV infection including oral candidiasis, history of multidermatomal zoster, unexplained weight loss in excess of 10 percent body weight in the past 6 months, chronic diarrhea, or history of AIDS-defining opportunistic infections.

Concurrent Medication:

Excluded:

• Concomitant medications (other than AZT) for the 14 days prior to start of therapy.

Patients with the following prior conditions are excluded:

• History of AZT intolerance including hematologic, hepatic, and/or neurologic toxicity.
• History of seizures.
• History of any antiepileptics within the past 10 years.
• History of abnormal bleeding or intrinsic or extrinsic coagulopathy.
• Signs or symptoms of HIV infection including oral candidiasis, history of multidermatomal zoster, unexplained weight loss in excess of 10 percent body weight in the past 6 months, chronic diarrhea, or history of AIDS-defining opportunistic infections.

Prior Medication:

Excluded:

• Antiepileptics within the past 10 years.
• Prior valproic acid.
• Concomitant medications (other than AZT) within 14 days of enrollment.