Status:
COMPLETED
Pharmacokinetics of Lamivudine at Two Different Doses
Lead Sponsor:
Kirby Institute
Conditions:
HIV Infections
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief 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 di...
Detailed 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...
Eligibility Criteria
Inclusion
- The ability to understand and sign a written informed consent form, prior to participation in any screening procedures and must be willing to comply with all study requirements
- Male or non-pregnant, non-lactating females
- Between 18 to 65 years, inclusive
- Body Mass Index (BMI) of 18 to 35 kg/m2, inclusive
- Women of childbearing potential must be using an adequate method of contraception to avoid pregnancy throughout the study and for a period of at least 1 month after the study.
Exclusion
- Any significant acute or chronic medical illness
- Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations
- Positive blood screen for hepatitis B core and/or C antibodies and/or hepatitis B surface antigen
- Positive blood screen for HIV-1 and/or 2 antibodies
- Current or recent (within 3 months) gastrointestinal disease
- Clinically relevant alcohol or drug use (positive urine drug screen) or history of alcohol or drug use considered by the Investigator to be sufficient to hinder compliance with treatment, follow-up procedures or evaluation of adverse events. Smoking is permitted, but tobacco intake should remain consistent throughout the study
- Exposure to any investigational drug or placebo within 3 months of first dose of study drug
- Use of any other drugs, including over-the-counter medications and herbal preparations, within two weeks prior to first dose of study drug, unless approved/prescribed by the Principal Investigator as known not to interact with study drugs
- Females of childbearing potential without the use of effective non-hormonal birth control methods, or not willing to continue practising these birth control methods for at least 30 days after the end of the treatment period
- Previous allergy to any of the constituents of the pharmaceuticals administered in this trial.
Key Trial Info
Start Date :
December 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00985647
Start Date
December 1 2009
End Date
March 1 2010
Last Update
February 11 2011
Active Locations (1)
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1
St Stephen's Centre, Chelsea and Westminster Hospital
London, United Kingdom