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CompletedNCT00002249Updated Jun 24, 2005

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

A Phase 1 interventional study of Levofloxacin in HIV Infections, sponsored by R W Johnson Pharmaceutical Research Institute. Completed at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2005-06-24.

Sponsored by R W Johnson Pharmaceutical Research Institute · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Ages
18 Years and older
Sex
Male
01

Study summary

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

02

Conditions studied

  • HIV Infections

Keywords

  • Anti-Infective Agents, Quinolone
  • Ofloxacin
  • Acquired Immunodeficiency Syndrome
03

In context

Infections

6,688 studies on the registry are indexed under Infections; 807 are open to participants now.

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Lead sponsor

R W Johnson Pharmaceutical Research Institute is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

Patients must have the following:

HIV infection.

Exclusion criteria

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.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Masking
Double

Interventions

  • DrugLevofloxacin
06

Study locations

1 site
  • R W Johnson Pharmaceutical Research Institute
    Raritan, New Jersey 088690602, United States
07

References and documents

Publications

  • Goodwin SD, Gallis HA, Chow AT, Wong FA, Flor SC, Bartlett JA. Pharmacokinetics and safety of levofloxacin in patients with human immunodeficiency virus infection. Antimicrob Agents Chemother. 1994 Apr;38(4):799-804. doi: 10.1128/AAC.38.4.799. PubMed 8031049 ↗
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2005, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00002249
Lead sponsor
R W Johnson Pharmaceutical Research Institute
First posted
Aug 31, 2001
Last update
Jun 24, 2005
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 1991. You cannot join it, but the record below documents what was studied.

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