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

Lederle Laboratories

Status: Completed

Conditions: HIV Infections

Treatments: Drug: Alovudine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00002260

81-3

054C

Details and patient eligibility

About

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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.