A Double-Blind Study to Evaluate the Safety and Pharmacokinetics of L-Ofloxacin (RWJ 25213) in Subjects With HIV Infection

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Male

Summary

To determine the safety and pharmacokinetics of L-ofloxacin (RWJ 25213) in patients with HIV infection.

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

Details

• Lead Sponsor: R W Johnson Pharmaceutical Research Institute
• Treatments: Levofloxacin; Ofloxacin

Criteria

Inclusion Criteria

Patients must have the following:

HIV infection.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

• Active opportunistic infection or neoplasm.

• High likelihood of death during study.

• Significant ophthalmologic, renal, hepatic, cardiovascular, hematologic, neurologic, psychiatric,respiratory, or metabolic disease.

• Donation of > 1 unit blood or acute loss of blood within one month of study entry.

Patients with the following prior conditions are excluded:

• History of opportunistic infection.

• Previous allergic reaction to ciprofloxacin, norfloxacin, or any other quinolone.

Prior Medication:

Excluded:

Use of any investigational agent within 7 days of entry into study. Use of any medication within 3 days prior to entry (7 days for AZT). Alcohol or drug abuse.