Completed

Effect of Food on Oral Bioavailability and Pharmacokinetic Profile of FLT in HIV-Infected Subjects

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What is being tested

Alovudine

Drug
Who is being recruted

Blood-Borne Infections+11

+ Urogenital Diseases

+ Genital Diseases

Over 18 Years
+12 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
See protocol details

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 individuals infected with Human Immunodeficiency Virus (HIV) who do not show any symptoms. The main goal is to learn about the drug's journey through the body after it is taken orally, in a liquid form, in two different scenarios: when the person has eaten and when they have not. This research is important as it helps to determine the best way to administer FLT, potentially improving treatment outcomes for HIV-infected individuals.

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

3 inclusion criteria required to participate
Asymptomatic

Positive ELISA test confirmed by Western blot analysis

Willing to sign an informed consent

9 exclusion criteria prevent from participating
Any malignancy other than cutaneous basal cell carcinoma or cervical carcinoma in situ

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

Significant chronic underlying medical illness which would prevent continuous participation in this clinical trial

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

Johns Hopkins Hosp

Baltimore, United StatesOpen Johns Hopkins Hosp in Google Maps
CompletedOne Study Center