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
Launched by LEDERLE LABORATORIES · Aug 30, 2001
Trial Information
Current as of June 12, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility criteria
- • 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.
About Lederle Laboratories
Lederle Laboratories, a distinguished pharmaceutical company, is recognized for its commitment to advancing healthcare through innovative research and development. With a rich history in vaccine production and biologics, Lederle Laboratories focuses on creating effective therapeutic solutions that address critical medical needs. The organization emphasizes rigorous clinical trial methodologies and adherence to regulatory standards, ensuring the safety and efficacy of its products. By fostering collaborations with healthcare professionals and research institutions, Lederle Laboratories strives to contribute significantly to the improvement of patient outcomes and public health.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Baltimore, Maryland, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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