Status:

COMPLETED

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

Lead Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Conditions:

Pneumonia, Pneumocystis Carinii

HIV Infections

Eligibility:

All Genders

18+ years

Phase:

PHASE1

Brief 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 t...

Detailed Description

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 w...

Eligibility 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.

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

End Date :

September 1 1993

Estimated Enrollment :

44 Patients enrolled

Trial Details

Trial ID

NCT00000740

End Date

September 1 1993

Last Update

November 4 2021

Active Locations (2)

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Page 1 of 1 (2 locations)

1

Indiana Univ. School of Medicine, Infectious Disease Research Clinic

Indianapolis, Indiana, United States, 46202

2

Johns Hopkins Adult AIDS CRS

Baltimore, Maryland, United States, 21287

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