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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lederle Laboratories
• Treatments: Alovudine; Dideoxynucleosides

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.