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
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Lederle Laboratories
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Patients must have:
Positive ELISA test confirmed by Western blot analysis.
Asymptomatic.
Willing to sign an informed consent.
You may not be if
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.
Clareo Health | 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
