An Ascending, Single Oral Dose Pharmacokinetic Study of 3'-Deoxy-3'-Fluorothymidine (FLT) in Asymptomatic Human Immunodeficiency Virus (HIV)-Infected Subjects
Completed · Not applicable
Conditions studied: HIV Infections
In brief
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.
Key facts
- Study ID
- NCT00002271
- Run by
- Lederle Laboratories
- Last updated by the study team
- 2005-06-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- 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:
- Excluded:
- 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.
Where it is running
- Johns Hopkins Hosp — Baltimore, Maryland, United States
Full record on ClinicalTrials.gov
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