- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00002260
An Open-Label, Crossover Study to Assess the Effect of Food on the Oral Bioavailability and Pharmacokinetic Profile of 3'-Deoxy-3'-Fluorothymidine (FLT) in Asymptomatic Human Immunodeficiency Virus (HIV)-Infected Subjects
June 23, 2005 updated by: Lederle Laboratories
To characterize the pharmacokinetics of orally administered FLT (in a liquid formulation) after single doses in both the fed and fasting states; to assess the effect of food on the oral bioavailability of FLT
Study Overview
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Maryland
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Baltimore, Maryland, United States, 21205
- Johns Hopkins Hosp
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria
Patients must have:
- Positive ELISA test confirmed by Western blot analysis.
- Asymptomatic.
- Willing to sign an informed consent.
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
- Oral candida infection documented by morphology or by a response to antifungal therapy within two months prior to study entry.
- Oral hairy leukoplakia at any time prior to entry.
- Temperature > 37.8 C.
- Any malignancy other than cutaneous basal cell carcinoma or cervical carcinoma in situ.
- Significant chronic underlying medical illness which would prevent continuous participation in this clinical trial.
- Unwilling to sign an informed consent.
- Zidovudine induced hematological toxicity.
Prior Medication:
Excluded:
- Therapy with antiretroviral drugs or immunomodulators within seven days before entry.
- Therapy with any investigational drug during the preceding 30 days.
Patients may not have:
- Oral candida infection documented by morphology or by a response to antifungal therapy within two months prior to study entry.
- Oral hairy leukoplakia at any time prior to entry.
- Temperature > 37.8 C.
- Any malignancy other than cutaneous basal cell carcinoma or cervical carcinoma in situ.
- Significant chronic underlying medical illness which would prevent continuous participation in this clinical trial.
- Unwilling to sign an informed consent.
- Zidovudine induced hematological toxicity.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Masking: None (Open Label)
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
November 2, 1999
First Submitted That Met QC Criteria
August 30, 2001
First Posted (Estimate)
August 31, 2001
Study Record Updates
Last Update Posted (Estimate)
June 24, 2005
Last Update Submitted That Met QC Criteria
June 23, 2005
Last Verified
March 1, 1992
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Slow Virus Diseases
- HIV Infections
- Acquired Immunodeficiency Syndrome
- Anti-Infective Agents
- Antiviral Agents
- Alovudine
Other Study ID Numbers
- 054C
- 81-3
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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