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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

For Condition: HIV Infections
Status: Completed
Sponsor(s): R W Johnson Pharmaceutical Research Institute ,
Synopsis: To determine the safety and pharmacokinetics of L-ofloxacin (RWJ 25213) in patients with HIV infection.
Details:
Eligibility:
Study Type:
  Interventional, Treatment, Double-Blind, Pharmacokinetics Study
Minimum Age/Maximum Age: 18 Years/
Genders: Male
Protocol Entry Criteria: 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.
Total Enrollment: 

Location and Contact Information:

R W Johnson Pharmaceutical Research Institute
Raritan,  New Jersey,  088690602
United States
 


Additional Information:
Study ID Numbers:
  105A/B;  K90-086,K90-024
Study Start Date: 
Record last reviewed: September 1991
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002249

Other Hiv Infections Studies:
1. A Study of PMPA in HIV-Infected Patients

2. A Clinical Trial To Evaluate the Toxicity and Antiviral Effects of a Range of Doses of Ampligen in p24 Antigen Positive HIV-Infected Patients With AIDS or ARC

3. Treating Genital Herpes to Decrease Risk of HIV Acquisition

4. Endothelial Dysfunction as a Risk Factor in HIV Study

5. Treatment of Abnormal Adipose Tissue Accumulation in HIV Patients

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