Skip to content

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

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00002249
Enrollment
Unknown
Registered
2001-08-31
Start date
Unknown
Completion date
Unknown
Last updated
2005-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

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

Brief summary

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

Interventions

DRUGLevofloxacin

Sponsors

R W Johnson Pharmaceutical Research Institute
Lead SponsorINDUSTRY

Study design

Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026