Pharmacokinetics of lamivudine at two different doses. v1.0

• Research type

  Research Study

• Full 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.

• IRAS ID

  22540

• Sponsor organisation

  National Centre in HIV Epidemiology & Clinical Research

• Eudract number

  2009-011844-20

• ISRCTN Number

  Not Known

• Research 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. 3TC is used to treat HIV infection and is approved at a dose of 300 mg once daily. There is, however, medical evidence that lower doses may work as well. Lower drug doses would make 3TC more affordable and could allow more people in developing countries to receive HIV treatment. 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 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 throughout the study to measure the levels of 3TC in blood and blood cells. Volunteers will visit the clinic on up to 6 occasions during the 31-day study period. On 2 of these visits, volunteers will need to stay in the unit for the whole day (approximately 12 hours). There will also be a screening visit up to 4 weeks before the study starts and a follow up visit 1-2 weeks after the last dose of study medication.

• REC name

  London - Riverside Research Ethics Committee

• REC reference

  09/H0706/50

• Date of REC Opinion

  11 Sep 2009

• REC opinion

  Further Information Favourable Opinion