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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.
Lamivudine (3TC) has been developed for the treatment of HIV−1 and Hepatitis B infection. 3TC has been approved by regulatory authorities for use in Europe and the current licensed dose for 3TC 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 tolerance of two different doses of 3TC in healthy volunteers. Healthy subjects as determined by their medical history and physical examination will be eligible to participate in the study. HIV−positive subjects 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 differences in the process of chemical changes inside the human body of 3TC between HIV−infected and HIV−uninfected people.
Female participants of childbearing age and ability (that is, not surgically sterile or post menopausal) must use effective barrier contraception (for example condoms, diaphragm, spermicides) for the duration of the study and for one month after the study. During the study, 4 pregnancy tests will be performed. Male subjects who have a female partner must also use barrier contraception while in the study and for at least 3 months after the study ends. No adequate studies of any of the study medications in pregnant women have been completed and there may be unknown risks to pregnant volunteers,the embryo/foetus or nursing infant. Participants will be notified if any important new information about pregnancy risk becomes available while participating in the study.
If a participant becomes pregnant, suspects a pregnancy, has a changed menstrual cycle or contraception method, the participant should immediately contact the study doctor. Participants who become pregnant during the study will be withdrawn from the study immediately and asked to seek obstetric care (care for women and their children during pregnancy and childbirth). The sponsor will not be responsible for the continued medical care of the participant and the child. In the case of a pregnancy, the study doctor will ask the participant to allow access to their medical records and to the medical records of their infant for a minimum of eight weeks after delivery. Male subjects will need to inform their study doctor if their partner becomes pregnant.
During the course of the study, participants may be found to have a previously undiagnosed medical condition. In this situation, the study doctor will take the necessary steps to ensure participants receive appropriate treatment. If participants have private medical insurance, they will be asked to check with the insurance company before agreeing to take part in the study.
At the screening visit, participants will be tested for HIV, Hepatitis B and Hepatitis C. If a participant tests positive, this could have implications for their insurance and possibly employment. These tests will be carried out by experienced doctors and if they do test positive, participants will be offered full counselling and support.
The study drug, 3TC, has potential side−effects. The most common adverse reactions are headache, nausea, malaise, fatigue, nasal signs and symptoms, diarrhea and cough. The participant's health will be closely monitored during the study and they have the right to ask questions and formally complain if they are unhappy through the NHS Complaints Procedure.
Allocation: Randomized, Control: Active Control, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
3TC 300 mg once daily orally, 3TC 150 mg once daily
Enrolling by invitation
The National Centre in HIV Epidemiology and Clinical Research
Published on BioPortfolio: 2014-08-27T03:18:59-0400
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