HIV Infections
Conditions
Keywords
Biological Availability, alovudine, Food
Brief 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
Interventions
DRUGAlovudine
Sponsors
Lederle Laboratories
Study design
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Countries
United States
Outcome results
None listed