Escalating Multiple-Dose Safety and Tolerance of WR 6026 Hydrochloride in HIV-Infected Subjects

Inclusion Criteria

Patients must have:

• HIV antibody positive.
• CD4 cell counts less than 500/mm3.
• Adequate general health.
• No significant deterioration in performance status within the past month.
• Prior treatment with a stable regimen of antiretroviral medication for at least 4 weeks prior to study.

Prior Medication:

Required:

• Stable regimen of antiretroviral medication for at least 4 weeks prior to study entry.

Allowed:

• Aerosolized pentamidine for PCP prophylaxis.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

• Intercurrent infection.
• Clinically significant abnormality on EKG.
• Known hypersensitivity to quinolines.
• Known hemoglobin M abnormality.
• Known NADH methemoglobin reductase deficiency.
• Positive test for G6PD deficiency.
• Fever.

Prior Medication:

Excluded:

• Other systemic medication (other than AZT, ddC, ddI, methadone, acyclovir, and NSAIDs) within 3 days prior to study entry.

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