NCT00002271CompletedNot Applicable
An Ascending, Single Oral Dose Pharmacokinetic Study of 3'-Deoxy-3'-Fluorothymidine (FLT) in Asymptomatic Human Immunodeficiency Virus (HIV)-Infected Subjects
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Lederle Laboratories
- Locations
- 1
Study Overview
Brief Summary
To characterize the pharmacokinetics of orally administered 3'-deoxy-3'-fluorothymidine (FLT), in a liquid formulation, after single doses in asymptomatic HIV-infected patients and to assess the safety and tolerance of the single oral doses of FLT.
Study Design
- Study Type
- Interventional
- Primary Purpose
- Treatment
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Exclusion Criteria
- •Co-existing Condition:
- •Patients with the following conditions or symptoms are excluded:
- •Oral candida infection documented by morphology or by response to antifungal therapy within 2 months prior to study entry.
- •Temperature > 37.8 degrees Centigrade.
- •Malignancy other than cutaneous basal cell carcinoma or cervical carcinoma in situ.
- •Significant chronic underlying medical illnesses which would prevent continuous participation in this clinical trial.
- •Concurrent Medication:
- •Patients with the following are excluded:
- •Significant chronic underlying medical illnesses which would prevent continuous participation in this clinical trial.
- •Unwilling to sign informed consent.
- •Intolerant to zidovudine (AZT).
- •Oral hairy leukoplakia at any time prior to study entry.
- •Prior Medication:
- •Excluded within 7 days of study entry:
- •Antiretroviral drugs.
- •Immunomodulators.
- •Excluded within 30 days of study entry:
- •Any investigational drugs.
- •Patients have the following:
- •HIV seropositivity by licensed ELISA test, confirmed by Western Blot analysis.
- •No symptoms as defined by:
- •Normal neurological exam.
- •Absence of the following:
- •Unintentional weight loss of greater than 10 pounds or more than 10 percent of usual body weight within 2 months prior to study entry.
- •Unexplained temperature > 37.8 C on more than 5 consecutive days or on more than 10 days in any 30 day period in the one month prior to expected study entry.
- •Unexplained diarrhea defined by = or > 3 liquid stools per day persisting > 7 days within 2 months prior to expected study entry.
Exclusion Criteria
- Not provided
Investigators
Study Sites (1)
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