Completed
Pharmacokinetics of Oral 3'-Deoxy-3'-Fluorothymidine (FLT) in Asymptomatic HIV-Infected Individuals
What is being tested
Alovudine
Drug
Who is being recruted
Blood-Borne Infections+11
+ Urogenital Diseases
+ Genital Diseases
Over 18 Years
+15 Eligibility Criteria
How is the trial designed
Treatment Study
Interventional
Summary
Principal SponsorLederle Laboratories
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner
This study focuses on understanding how a drug called 3'-deoxy-3'-fluorothymidine (FLT) works in asymptomatic individuals who have Human Immunodeficiency Virus (HIV). The main goal is to learn about the journey of this drug in the body, also known as pharmacokinetics, when it's given as a single dose in a liquid form. The study also aims to see if this drug is safe and well-tolerated by these individuals, which is crucial for developing effective HIV treatments.
Principal SponsorLederle Laboratories
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsHIV Infections
Criteria
2 inclusion criteria required to participate
HIV seropositivity by licensed ELISA test, confirmed by Western Blot analysis
No symptoms as defined by: normal neurological exam and absence of specified symptoms
13 exclusion criteria prevent from participating
Intolerant to zidovudine (AZT)
Malignancy other than cutaneous basal cell carcinoma or cervical carcinoma in situ
Oral candida infection documented by morphology or by response to antifungal therapy within 2 months prior to study entry
Oral hairy leukoplakia at any time prior to study entry
Show More Criteria
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
CompletedOne Study Center