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

NCT00002249 | Completed Phase 1

• 3 other identifiers: 105A/BK90-086K90-024
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

HIV Infections

Keywords

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

Interventions

Levofloxacin DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have the following:
• HIV infection.

You may not qualify if:

• 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.

Sponsors & Collaborators

• R W Johnson Pharmaceutical Research Institute: lead

Study Sites (1)

R W Johnson Pharmaceutical Research Institute

Raritan, New Jersey, 088690602, United States

Location

Related Publications (1)

• 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.

  PMID: 8031049 BACKGROUND

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome

Interventions

Levofloxacin

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Ofloxacin; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: DOUBLE
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Last Updated: June 24, 2005

Record last verified: 1991-09

Locations

US (1)