Track topics on Twitter Track topics that are important to you
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
To investigate the influence of different dosage regimen (5 mg twice daily versus 10 mg once daily) on the steady state pharmacokinetics and pharmacodynamics of BI 10773 administered orall...
This study will evaluate the safety, tolerability and pharmacokinetics of X4P-001 administered as 200 mg twice daily compared with 400 mg once daily. This study will also assess the pharm...
To compare the effect of daily valacyclovir 1 gram orally twice daily versus acyclovir 400 mg orally twice daily on the frequency of genital HSV reactivation and on plasma and genital HIV-...
The objective of the study is to investigate the efficacy and safety of linagliptin 2.5 mg twice daily compared to 5 mg once daily compared to placebo given orally for 12 weeks as add-on t...
The purpose of this study is to assess the safety and tolerability of the KIT inhibitor XL820 when given orally daily to adults with advanced solid tumors.
We present a 35-year-old female patient who was started on rifampicin (900 mg orally once daily) and trimethoprim/sulfamethoxazole (TMP/SMX) (160/800 mg orally twice daily) after being diagnosed wit...
Never, non-daily, and daily smoking status and progression to daily cigarette smoking as correlates of major depressive episode in a national sample of youth: Results from the National Survey of Drug Use and Health 2013 to 2015.
Cigarette smoking is associated with depression, and new initiates who progress more quickly to daily smoking may be at enhanced risk. In a nationally representative sample of youth, this study examin...
Abacavir is a widely used nucleotide reverse transcriptase inhibitor whose cerebrospinal fluid (CSF) exposure has been previously assessed in twice-daily recipients. We studied abacavir CSF concentrat...
Daily drinking is an important public health concern and informative for evaluating diagnostic classification. In particular, daily binge drinkers might be considered as the prototype of some forms of...
This study was aimed at evaluating whether once-daily regimens (od-r) show benefits in adherence when compared to twice-daily (td-r).
Total number of calories taken in daily whether ingested or by parenteral routes.
The use of electronic equipment to observe or record physiologic processes while the patient undergoes normal daily activities.
Voluntary use of free time for activities outside the daily routine.
The performance of the basic activities of self care, such as dressing, ambulation, or eating.
Persons with loss of vision such that there is an impact on activities of daily living.
Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...
Antiretroviral Therapy Clostridium Difficile Ebola HIV & AIDS Infectious Diseases Influenza Malaria Measles Sepsis Swine Flu Tropical Medicine Tuberculosis Infectious diseases are caused by pathogenic...