ClinConnect ClinConnect Logo
Search / 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

Launched by LEDERLE LABORATORIES · Aug 30, 2001

Trial Information

Current as of June 12, 2025

Completed

Keywords

Biological Availability Alovudine Food

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.

Locations

Baltimore, Maryland, United States

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Similar Trials