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

• Status: Completed
• Trial end date: 1993-09-01
• Target enrollment: 0
• Participant gender: All

Summary

To determine the maximum tolerated dose (MTD) of WR 6026 in HIV-infected patients. To determine whether any unexpected toxicities are caused by WR 6026 in HIV-infected patients. To determine whether there is additional toxicity when WR 6026 is given for 21 days rather than 14 days. To further investigate the pharmacokinetics and pharmacodynamics of WR 6026, and in particular to examine potential correlations between the area under the concentration-time curve and methemoglobinemia or other toxicities.

In recent animal studies, WR 6026 demonstrated inhibitory activity against Pneumocystis carinii pneumonia (PCP). This study will assess the safety and tolerance of this drug in HIV-infected patients who do not have PCP.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Criteria

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.