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

This study has been completed.
Information provided by:
NIH AIDS Clinical Trials Information Service Identifier:
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: September 1991
To determine the safety and pharmacokinetics of L-ofloxacin (RWJ 25213) in patients with HIV infection.

Condition Intervention Phase
HIV Infections
Drug: Levofloxacin
Phase 1

Study Type: Interventional
Study Design: Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Double-Blind Study to Evaluate the Safety and Pharmacokinetics of L-Ofloxacin (RWJ 25213) in Subjects With HIV Infection

Resource links provided by NLM:

Further study details as provided by NIH AIDS Clinical Trials Information Service:


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts 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:


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.

  Contacts and Locations
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Please refer to this study by its identifier: NCT00002249

United States, New Jersey
R W Johnson Pharmaceutical Research Institute
Raritan, New Jersey, United States, 088690602
Sponsors and Collaborators
R W Johnson Pharmaceutical Research Institute
  More Information

Publications: Identifier: NCT00002249     History of Changes
Other Study ID Numbers: 105A/B
Study First Received: November 2, 1999
Last Updated: June 23, 2005

Keywords provided by NIH AIDS Clinical Trials Information Service:
Anti-Infective Agents, Quinolone
Acquired Immunodeficiency Syndrome

Additional relevant MeSH terms:
Communicable Diseases
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Anti-Bacterial Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors processed this record on May 25, 2017