Pharmacokinetics of Lamivudine at Two Different Doses — ENCORE2  

HIV Infections Clinical Trial

Official title: Pharmacokinetics of Plasma Lamivudine (3TC), and Its Active Intracellular Anabolite 3TC−Triphosphate Over a 24 Hour Dosing Interval Following Administration of 3TC 300 mg and 150 mg Once Daily to HIV−Negative Healthy Volunteers

Status Completed

Clinical Trial Summary

The purpose of the study is to measure the pharmacokinetics (how a drug is absorbed, distributed and eliminated from the body) of lamivudine (3TC) and its active component after 3TC is given at two different doses, 300mg and 150mg once daily.

Clinical Trial Description

Lamivudine (3TC) has been approved by regulatory authorities for the treatment of HIV infection and the current licensed dose is 300 mg once daily. Clinical and pharmacokinetic (how a drug is absorbed, distributed and eliminated from your body) data suggest that the licensing dose could be reduced without compromising effectiveness. Lower drug doses could reduce the side−effects from the medication and would make 3TC more affordable.

This study will compare the pharmacokinetics, safety and tolerability of two different doses of 3TC in healthy volunteers. The study will take place at Chelsea and Westminster Hospital. Twenty four healthy HIV negative volunteers will be randomly allocated into two groups. Volunteers in Group 1 will start 300mg 3TC once daily for 10 days, followed by 10 days of not taking any 3TC (wash−out period). When the wash−out period ends, they will re−start 3TC at a dose of 150mg once daily for 10 days. Group 2 is similar except that they will start 150mg 3TC at the beginning of the study and 300mg 3TC after the wash−out period. Blood samples will be taken over a 24-hour period at the end of each dosing phase to measure the levels of 3TC in the blood and inside blood cells. Safety and tolerability of 3TC will be assessed by questions, physical examination and laboratory parameters. These will be performed at regular intervals during the treatment phases.

Healthy participants as determined by their medical history and physical examination will be eligible to participate in the study. HIV−positive participants will not be recruited because it is not yet clear if an experimentally reduced dose of 3TC will successfully treat HIV−infection. There is no reason to presume that there is any meaningful difference in the metabolic processing of 3TC between HIV−infected and HIV−uninfected people. ;

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

• NCT number: NCT00985647
• Study type: Interventional
• Source: Kirby Institute
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: December 2009
• Completion date: March 2010