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

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.