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
HIV Infections
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Biological Availability, alovudine, Food
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.
Sites / Locations
- Johns Hopkins Hosp