A Double-Blind Study to Evaluate the Safety and Pharmacokinetics of L-Ofloxacin (RWJ 25213) in Subjects With HIV Infection
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00002249 |
Recruitment Status :
Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Drug: Levofloxacin | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Masking: | Double |
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 |

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
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:
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002249
United States, New Jersey | |
R W Johnson Pharmaceutical Research Institute | |
Raritan, New Jersey, United States, 088690602 |
ClinicalTrials.gov Identifier: | NCT00002249 |
Other Study ID Numbers: |
105A/B K90-086 K90-024 |
First Posted: | August 31, 2001 Key Record Dates |
Last Update Posted: | June 24, 2005 |
Last Verified: | September 1991 |
Anti-Infective Agents, Quinolone Ofloxacin Acquired Immunodeficiency Syndrome |
Infections Communicable Diseases HIV Infections Acquired Immunodeficiency Syndrome Disease Attributes Pathologic Processes Blood-Borne Infections Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Immunologic Deficiency Syndromes Immune System Diseases |
Slow Virus Diseases Levofloxacin Ofloxacin 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 |