HIV InfectionsPhase 1/2ENCORE2NCT00985647
Pharmacokinetics of Lamivudine at Two Different Doses
A Phase 1/2 study testing Lamivudine (3TC) in people with HIV Infections, run by Kirby Institute at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- Lamivudine (3TC)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2009to Mar 2010
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
St Stephen's Centre, Chelsea and Westminster Hospital
London
About this study
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
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.
Read the 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, 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.
- Conditions
- HIV Infections
- Being tested
- Lamivudine (3TC)
- Keywords
- HIV, HAART, ART, Pharmacokinetic, Healthy volunteers, 3TC, Lamivudine
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lamivudine (3TC)Drug
Also called Epivir
3TC 300mg/150mg participants will receive 3TC 300 mg (2 x 150 mg tablet) once daily for 10 days, washout for 10 days and then 3TC 150 mg (1 x 150 mg tablet) once daily for 10 days.
3TC 150mg/300mg participants will receive 3TC 150 mg (1 x 150 mg tablet) once daily for 10 days, washout for 10 days and then 3TC 300 mg (2 x 150 mg tablet) once daily for 10 days.
| Study group | Role | What they receive |
|---|---|---|
| 3TC 300mg/150mg | Active comparator | Group 1: Participants will be administered 3TC 300 mg once daily orally for 10 days. A 10 day wash-out period will follow (days 11-20). From day 21, participants will be administered 3TC 150 mg once daily for 10 days Receives: Drug: Lamivudine (3TC) |
| 3TC 150mg/300mg | Active comparator | Group 2: Participants will be administered 3TC 150 mg once daily orally for 10 days. A 10 day wash-out period will follow (days 11-20). From day 21, participants will be administered 3TC 300 mg once daily for 10 days Receives: Drug: Lamivudine (3TC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentrations of 3TC and intracellular concentrations of its active anabolite 3TC-TP as measured by the Area Under the Curve (AUC 0-24h).
Concentrations will be compared after the administration of 3TC 300 mg and 150 mg once daily.
Measured: Measured over 24 hours at the end of each 10-day dosing period.
Secondary outcomes (1)
Safety and tolerability of 3TC following the administration of 3TC 300 mg and 150 mg once daily
Measured: Assessed at regular intervals throughout the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2009 (estimated)
- Study startDec 2009
- Primary completionFeb 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kirby Institute
- Sponsor type
- Other government
- Investigators
- Marta Boffito, MD PhD, Principal investigator, Chelsea and Westminster Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00985647
- Sponsor's protocol ID
- NCHECR-ENCORE2
- Acronym
- ENCORE2
- Status last verified
- Feb 2011
- First submitted
- 25 Sep 2009
- Last updated
- 11 Feb 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00985647
- Acronym / sponsor ID
- ENCORE2 / NCHECR-ENCORE2
- Conditions
- HIV Infections
- Keywords
- HIV, HAART, ART, Pharmacokinetic, Healthy volunteers, 3TC, Lamivudine
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Kirby InstituteOther government
- Study start
- Dec 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 28 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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, 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3TC 300mg/150mg | Active comparator | Drug: Lamivudine (3TC)Group 1: Participants will be administered 3TC 300 mg once daily orally for 10 days. A 10 day wash-out period will follow (days 11-20). From day 21, participants will be administered 3TC 150 mg once daily for 10 days |
| 3TC 150mg/300mg | Active comparator | Drug: Lamivudine (3TC)Group 2: Participants will be administered 3TC 150 mg once daily orally for 10 days. A 10 day wash-out period will follow (days 11-20). From day 21, participants will be administered 3TC 300 mg once daily for 10 days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lamivudine (3TC)Also: Epivir3TC 300mg/150mg participants will receive 3TC 300 mg (2 x 150 mg tablet) once daily for 10 days, washout for 10 days and then 3TC 150 mg (1 x 150 mg tablet) once daily for 10 days. 3TC 150mg/300mg participants will receive 3TC 150 mg (1 x 150 mg tablet) once daily for 10 days, washout for 10 days and then 3TC 300 mg (2 x 150 mg tablet) once daily for 10 days. | Drug | 3TC 150mg/300mg, 3TC 300mg/150mg |
Primary outcome
Plasma concentrations of 3TC and intracellular concentrations of its active anabolite 3TC-TP as measured by the Area Under the Curve (AUC 0-24h).
Time frame: Measured over 24 hours at the end of each 10-day dosing period.
Concentrations will be compared after the administration of 3TC 300 mg and 150 mg once daily.
1 secondary outcome
Safety and tolerability of 3TC following the administration of 3TC 300 mg and 150 mg once daily
Time frame: Assessed at regular intervals throughout the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marta Boffito, MD PhD principal investigator
Chelsea and Westminster Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Lamivudine (3TC) in people with HIV Infections, run by Kirby Institute at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma concentrations of 3TC and intracellular concentrations of its active anabolite 3TC-TP as measured by the Area Under the Curve (AUC 0-24h). (time frame: Measured over 24 hours at the end of each 10-day dosing period.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2011.