Escalating Multiple-Dose Safety and Tolerance of WR 6026 Hydrochloride in HIV-Infected Subjects
Status:
Completed
Trial end date:
1993-09-01
Target enrollment:
Participant gender:
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
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)