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An Ascending, Single Oral Dose Pharmacokinetic Study of 3'-Deoxy-3'-Fluorothymidine (FLT) in Asymptomatic Human Immunodeficiency Virus (HIV)-Infected Subjects

An Ascending, Single Oral Dose Pharmacokinetic Study of 3'-Deoxy-3'-Fluorothymidine (FLT) in Asymptomatic Human Immunodeficiency Virus (HIV)-Infected Subjects

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00002271
Enrollment
Unknown
Registered
2001-08-31
Start date
Unknown
Completion date
Unknown
Last updated
2005-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

Thymidine, Nucleosides, Antiviral Agents

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.

Interventions

Sponsors

Lederle Laboratories
Lead SponsorINDUSTRY

Study design

Primary purpose
TREATMENT

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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: 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: 1. Normal neurological exam. 2. 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026