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
Completed · Not applicable
Conditions studied: HIV Infections
In brief
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
Key facts
- Study ID
- NCT00002260
- 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 qualify if…
- Patients must have:
- Positive ELISA test confirmed by Western blot analysis.
- Asymptomatic.
- Willing to sign an informed consent.
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 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.
Where it is running
- Johns Hopkins Hosp — Baltimore, Maryland, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.