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| Sponsor: | R W Johnson Pharmaceutical Research Institute |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002249 |
Purpose
To determine the safety and pharmacokinetics of L-ofloxacin (RWJ 25213) in patients with HIV infection.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Levofloxacin |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Double-Blind, Pharmacokinetics Study |
| Official Title: | A Double-Blind Study to Evaluate the Safety and Pharmacokinetics of L-Ofloxacin (RWJ 25213) in Subjects With HIV Infection |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders 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:
Patients with the following prior conditions are excluded:
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.
Contacts and Locations
More Information
| Study ID Numbers: | 105A/B, K90-086, K90-024 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002249 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Anti-Infective Agents, Quinolone Ofloxacin Acquired Immunodeficiency Syndrome |
|
Anti-Infective Agents Communicable Diseases RNA Virus Infections Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Immune System Diseases Ofloxacin Acquired Immunodeficiency Syndrome Anti-Infective Agents, Urinary Enzyme Inhibitors Renal Agents |
Infection Pharmacologic Actions Immunologic Deficiency Syndromes Virus Diseases Anti-Bacterial Agents HIV Infections Therapeutic Uses Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections Nucleic Acid Synthesis Inhibitors |