Infection, Human Immunodeficiency VirusPhase 1NCT01593046
A Study to Investigate the Safety, Tolerability and Pharmacokinetics of Repeat Dose Administration of Long-Acting GSK1265744 and Long-Acting TMC278 Intramuscular and Subcutaneous Injections in Healthy Adult Subjects
A Phase 1 study testing GSK1265744 Oral, GSK1265744 LAP 800mg intramuscular injection and GSK1265744 LAP 200mg subcutaneous injection in people with Infection, Human Immunodeficiency Virus, run by ViiV Healthcare at 2 sites in United States.
Trial summary
LAI115428 is a Phase I, randomized, repeat dose escalation study to determine the safety, tolerability, and PK profile of intramuscular and subcutaneous injections of GSK1265744 in a long acting parenteral (LAP) formulation in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Infection, Human Immunodeficiency Virus
- What is being tested?
- GSK1265744 Oral, GSK1265744 LAP 800mg intramuscular injection and GSK1265744 LAP 200mg subcutaneous injection
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2012to Nov 2013
- Phase
- Phase 1
- 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 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- AST, ALT, alkaline phosphatase and bilirubin greater than or equal to 1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
- Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinically significant abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
- Male or female between 18 and 64 years of age inclusive, at the time of signing the informed consent.
- Females of childbearing potential with a negative pregnancy test (serum or urine) at screen and at Day -21, and agrees to use one of the contraception methods listed in the protocol for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use contraception for six months after the final dose of study drug.
- Body weight greater than or equal to 50 kg for men and greater than or equal to 45 kg for women and body mass index (BMI) within the range 18.5-31.0 kg/m2 (inclusive).
- All Study subjects should be counseled on the practice of safer sexual practices including the use of effective barrier methods (e.g. male condom/spermicide).
Who cannot join
- History of bleeding or clotting disorders including disseminated intravascular coagulation, hemophilia Henoch-Schönlein purpura (allergic purpura), hereditary hemorrhagic telangiectasia, thrombocytopenia, thrombophilia or Von Willebrand's disease.
- High-risk behavior for HIV infection including one of the following risk factors within six months before entering the study (day 1): Unprotected vaginal or anal sex with a known HIV infected person or a casual partner, engaged in sex work for money or drugs, acquired a sexually transmitted disease, high risk partner currently or in the previous six months.
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- A positive pre-study (screening and Day -21) drug/alcohol screen.
- History of regular alcohol consumption within 6 months of the study as defined in the protocol.
Show all 18Show fewer
- The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
- Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
- Refrain from use of prescription or non-prescription drugs, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
- History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation. If heparin is used during PK sampling, subjects with a history or sensitivity to heparin or heparin-induced thrombocytopenia should not be enrolled.
- The subject has an underlying skin disease or disorder (i.e. infection, inflammation, dermatitis, eczema, drug rash, drug allergy, psoriasis, food allergy, urticaria. Mild cases of localized acne or folliculitis are not exclusionary.)
- The subject has a tattoo or other dermatological condition overlying the gluteus and/or abdominal region which may interfere with interpretation of injection site reactions.
- Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
- Pregnant females as determined by positive serum or urine hCG test at screening or prior to dosing.
- Unwillingness or inability to follow the procedures outlined in the protocol.
- Subject is mentally or legally incapacitated.
- The subject's systolic blood pressure is outside the range of 90-140mmHg, or diastolic blood pressure is outside the range of 45-90mmHg or heart rate is outside the range of 50-100bpm for female subjects or 45-100 bpm for male subjects.
- History of clinically significant cardiovascular disease.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
GSK Investigational Site
Daytona Beach, Florida, 32117
GSK Investigational Site
Overland Park, Kansas, 66211
About this study
Official title: A Randomized, Open Label Study to Investigate the Safety, Tolerability and Pharmacokinetics of Repeat Dose Administration of Long-Acting GSK1265744 and Long-Acting TMC278 Intramuscular and Subcutaneous Injections in Healthy Adult Subjects
LAI115428 is a Phase I, randomized, repeat dose escalation study to determine the safety, tolerability, and PK profile of intramuscular and subcutaneous injections of GSK1265744 in a long acting parenteral (LAP) formulation in healthy subjects. Subjects will be randomized to 3 monthly dosing cohorts and 1 quarterly dosing cohort with either intramuscular or subcutaneous dosing. In the monthly dosing cohorts subjects will receive GSK1265744 alone for 2 months and then in combination with TMC278 long acting parenteral (LA) for 2 months. For the quarterly dosing cohort, 2 quarterly intramuscular doses of GSK1265744 LAP will be given alone. Three dose levels of GSK1265744 will be evaluated partly in combination with TMC278 LA to adequately characterize the GSK1265744 LAP and TMC278 LA safety, tolerability, and PK profile. A total enrolment of approximately 40 healthy subjects is planned for this study.
- Conditions
- Infection, Human Immunodeficiency Virus
- Being tested
- GSK1265744 Oral, GSK1265744 LAP 800mg intramuscular injection, GSK1265744 LAP 200mg subcutaneous injection, GSK1265744 LAP 200mg intramuscular injection, GSK1265744 LAP 400mg intramuscular injection
- Keywords
- GSK1265744 LAP, integrase inhibitor, healthy subjects, TMC278 LA, GSK1265744LAP, long acting retroviral, HIV-1 infection
- Medical subject headings
- Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK1265744 OralDrug
Also called GSK1265744
30mg tablet
GSK1265744 LAP 800mg intramuscular injectionDrug
Also called GSK1265744
800mg Loading dose given at month 1 dose
GSK1265744 LAP 200mg subcutaneous injectionDrug
Also called GSK1265744
200mg maintenance dose give at months 2 - 4
GSK1265744 LAP 200mg intramuscular injectionDrug
Also called GSK1265744
200mg maintenance dose given at months 2 - 4
GSK1265744 LAP 400mg intramuscular injectionDrug
Also called GSK1265744
400mg maintenance dose given at month 2 - 4
TMC278 LA 1200mg intramuscular injectionDrug
Also called TMC278 LA
1200mg Loading dose given at month 3
TMC278 LA 600mg intramuscular injectionDrug
Also called TMC278 LA
600mg Loading dose given at month 4
GSK1265744 LAP 800mg intramuscular injectionDrug
Also called GSK1265744
800mg dose given quarterly (once every) 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Run-in Period | Experimental | Oral GSK1265744 30mg once daily for 14 days Receives: Drug: GSK1265744 Oral |
| Cohort 1 | Experimental | GSK1265744 LAP injection given subcutaneously once a month for 4 months Receives: Drug: GSK1265744 LAP 800mg intramuscular injection; Drug: GSK1265744 LAP 200mg subcutaneous injection |
| Cohort 2 | Experimental | GSK1265744 LAP injection given intramuscularly once a month for 4 months. TMC278 LA + GSK1265744 given in Month 3 and 4. Receives: Drug: GSK1265744 LAP 800mg intramuscular injection; Drug: GSK1265744 LAP 200mg intramuscular injection; Drug: TMC278 LA 1200mg intramuscular injection; Drug: TMC278 LA 600mg intramuscular injection |
| Cohort 3 | Experimental | GSK1265744 LAP injection given intramuscularly once a month for 4 months. TMC278 LA + GSK1265744 given in Month 3 and 4. Receives: Drug: GSK1265744 LAP 800mg intramuscular injection; Drug: GSK1265744 LAP 400mg intramuscular injection; Drug: TMC278 LA 1200mg intramuscular injection; Drug: TMC278 LA 600mg intramuscular injection |
| Cohort 4 | Experimental | GSK1265744 LAP injection given intramuscularly once every 12 weeks. Receives: Drug: GSK1265744 LAP 800mg intramuscular injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
GSK1265744 LAP safety and tolerability parameters including the collection of adverse events
Measured: approximately 25 weeks
GSK1265744 LAP safety and tolerability parameters including change from baseline in clinical laboratory safety assessments
Hematology, Clinical Chemistry and Urinalysis
Measured: approximately 25 weeks
GSK1265744 LAP safety and tolerability parameters including change from baseline in electrocardiogram (ECG) measurements
Measured: approximately 25 weeks
GSK1265744 LAP safety and tolerability parameters including change from baseline in vital sign measurements
Blood pressure and heart rate
Measured: approximately 25 weeks
TMC278 LA safety and tolerability parameters including the collection of adverse events
Measured: approximately 12 weeks
TMC278 LA safety and tolerability parameters including change from baseline in clinical laboratory safety assessments
Hematology, Clinical Chemistry and Urinalysis
Measured: approximately 12 weeks
TMC278 LA safety and tolerability parameters including change from baseline in ECG measurements
Measured: approximately 12 weeks
TMC278 LA safety and tolerability parameters including change from baseline in vital sign measurements
Blood pressure and heart rate
Measured: approximately 12 weeks
Composite of PK parameters following single and repeat dose intramuscular or subcutaneous administration
Measurements include: area under the plasma concentration time curve over the dosing interval (AUC(0-t)), maximum observed concentration (Cmax), time to maximum observed concentration (tmax), concentration at the end of the dosing interval (Ct).
Measured: approximately 25 weeks
Composite of GSK1265744 pharmacokinetic parameters following repeat dose oral administration
Measurements include: area under the plasma concentration time curve over the dosing interval (AUC(0-t)), maximum observed concentration (Cmax), time to maximum observed concentration (tmax), concentration at the end of the dosing interval (Ct).
Measured: approximately 25 weeks
Composite of TMC278 LA pharmacokinetic parameters following single and repeat dose intramuscular administration
Measurements include: area under the plasma concentration time curve over the dosing interval (AUC(0-t)), maximum observed concentration (Cmax), time to maximum observed concentration (tmax), concentration at the end of the dosing interval (Ct).
Measured: approximately 12 weeks
GSK1265744 LAP safety and tolerability parameters including change from baseline for clinical chemistry assessments (ALT, AST, ALP, Total and Direct Bilirubin).
Measured: 52 weeks
Secondary outcomes (8)
GSK1265744 oral formulation safety and tolerability parameters including the collection of adverse events
Measured: 21 days
GSK1265744 oral formulation safety and tolerability parameters including change from baseline in clinical laboratory safety assessments
Hematology, Clinical Chemistry and Urinalysis
Measured: 21 days
GSK1265744 oral formulation safety and tolerability parameters including change from baseline in ECG measurements
Measured: 21 days
GSK1265744 oral formulation safety and tolerability parameters including change from baseline in vital sign measurements
Blood pressure and heart rate
Measured: 21 days
Composite of PK parameters of GSK1265744 LAP and TMC278 LA
Measurements include: apparent clearance (CL/FLAP) following single and repeat dose administration.
Measured: approximately 12 weeks
Composite of PK parameters following each dose administration at different dose levels for the assessment of dose proportionality and relative exposure
Measurements include: GSK1265744 LAP AUC(0-t), Cmax, and Ct
Measured: approximately 25 weeks
Composite of PK parameters for GSK1265744 LAP
Measurements include: apparent terminal phase half-life for LAP administration (t½), lambda z as a measure of absorption rate constant if data allow
Measured: approximately 25 weeks
Composite of PK parameters of TMC278 LA
Measurements include: AUC(0-t), Cmax, and Ct in cohort 2 and 3
Measured: approximately 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2012 (estimated)
- Study startMay 2012
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infection, Human Immunodeficiency VirusStudies of the same condition, open and under way.
- More trials run by ViiV HealthcareThe sponsor's other registered studies.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- ViiV Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, ViiV Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01593046
- Sponsor's protocol ID
- 115428
- Status last verified
- Jan 2014
- First submitted
- 3 May 2012
- Last updated
- 10 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open Label Study to Investigate the Safety, Tolerability and Pharmacokinetics of Repeat Dose Administration of Long-Acting GSK1265744 and Long-Acting TMC278 Intramuscular and Subcutaneous Injections in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT01593046
- Acronym / sponsor ID
- 115428
- Conditions
- Infection, Human Immunodeficiency Virus
- Keywords
- GSK1265744 LAP, integrase inhibitor, healthy subjects, TMC278 LA, GSK1265744LAP, long acting retroviral, HIV-1 infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- ViiV HealthcareIndustry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Study start
- May 2012
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 7 May 2012 (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.
LAI115428 is a Phase I, randomized, repeat dose escalation study to determine the safety, tolerability, and PK profile of intramuscular and subcutaneous injections of GSK1265744 in a long acting parenteral (LAP) formulation in healthy subjects. Subjects will be randomized to 3 monthly dosing cohorts and 1 quarterly dosing cohort with either intramuscular or subcutaneous dosing. In the monthly dosing cohorts subjects will receive GSK1265744 alone for 2 months and then in combination with TMC278 long acting parenteral (LA) for 2 months. For the quarterly dosing cohort, 2 quarterly intramuscular doses of GSK1265744 LAP will be given alone. Three dose levels of GSK1265744 will be evaluated partly in combination with TMC278 LA to adequately characterize the GSK1265744 LAP and TMC278 LA safety, tolerability, and PK profile. A total enrolment of approximately 40 healthy subjects is planned for this study.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Run-in Period | Experimental | Drug: GSK1265744 OralOral GSK1265744 30mg once daily for 14 days |
| Cohort 1 | Experimental | Drug: GSK1265744 LAP 800mg intramuscular injection, Drug: GSK1265744 LAP 200mg subcutaneous injectionGSK1265744 LAP injection given subcutaneously once a month for 4 months |
| Cohort 2 | Experimental | Drug: GSK1265744 LAP 800mg intramuscular injection, Drug: GSK1265744 LAP 200mg intramuscular injection, Drug: TMC278 LA 1200mg intramuscular injection, Drug: TMC278 LA 600mg intramuscular injectionGSK1265744 LAP injection given intramuscularly once a month for 4 months. TMC278 LA + GSK1265744 given in Month 3 and 4. |
| Cohort 3 | Experimental | Drug: GSK1265744 LAP 800mg intramuscular injection, Drug: GSK1265744 LAP 400mg intramuscular injection, Drug: TMC278 LA 1200mg intramuscular injection, Drug: TMC278 LA 600mg intramuscular injectionGSK1265744 LAP injection given intramuscularly once a month for 4 months. TMC278 LA + GSK1265744 given in Month 3 and 4. |
| Cohort 4 | Experimental | Drug: GSK1265744 LAP 800mg intramuscular injectionGSK1265744 LAP injection given intramuscularly once every 12 weeks. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- AST, ALT, alkaline phosphatase and bilirubin greater than or equal to 1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
- Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinically significant abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
- Male or female between 18 and 64 years of age inclusive, at the time of signing the informed consent.
- Females of childbearing potential with a negative pregnancy test (serum or urine) at screen and at Day -21, and agrees to use one of the contraception methods listed in the protocol for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use contraception for six months after the final dose of study drug.
- Body weight greater than or equal to 50 kg for men and greater than or equal to 45 kg for women and body mass index (BMI) within the range 18.5-31.0 kg/m2 (inclusive).
Key exclusion criteria (18 listed)
- History of bleeding or clotting disorders including disseminated intravascular coagulation, hemophilia Henoch-Schönlein purpura (allergic purpura), hereditary hemorrhagic telangiectasia, thrombocytopenia, thrombophilia or Von Willebrand's disease.
- High-risk behavior for HIV infection including one of the following risk factors within six months before entering the study (day 1): Unprotected vaginal or anal sex with a known HIV infected person or a casual partner, engaged in sex work for money or drugs, acquired a sexually transmitted disease, high risk partner currently or in the previous six months.
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- A positive pre-study (screening and Day -21) drug/alcohol screen.
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 |
|---|---|---|
| GSK1265744 OralAlso: GSK126574430mg tablet | Drug | Run-in Period |
| GSK1265744 LAP 800mg intramuscular injectionAlso: GSK1265744800mg Loading dose given at month 1 dose | Drug | Cohort 1, Cohort 2, Cohort 3 |
| GSK1265744 LAP 200mg subcutaneous injectionAlso: GSK1265744200mg maintenance dose give at months 2 - 4 | Drug | Cohort 1 |
| GSK1265744 LAP 200mg intramuscular injectionAlso: GSK1265744200mg maintenance dose given at months 2 - 4 | Drug | Cohort 2 |
| GSK1265744 LAP 400mg intramuscular injectionAlso: GSK1265744400mg maintenance dose given at month 2 - 4 | Drug | Cohort 3 |
| TMC278 LA 1200mg intramuscular injectionAlso: TMC278 LA1200mg Loading dose given at month 3 | Drug | Cohort 2, Cohort 3 |
| TMC278 LA 600mg intramuscular injectionAlso: TMC278 LA600mg Loading dose given at month 4 | Drug | Cohort 2, Cohort 3 |
| GSK1265744 LAP 800mg intramuscular injectionAlso: GSK1265744800mg dose given quarterly (once every) 12 weeks | Drug | Cohort 4 |
Primary outcome
GSK1265744 LAP safety and tolerability parameters including the collection of adverse events
Time frame: approximately 25 weeks
GSK1265744 LAP safety and tolerability parameters including change from baseline in clinical laboratory safety assessments
Time frame: approximately 25 weeks
Hematology, Clinical Chemistry and Urinalysis
GSK1265744 LAP safety and tolerability parameters including change from baseline in electrocardiogram (ECG) measurements
Time frame: approximately 25 weeks
GSK1265744 LAP safety and tolerability parameters including change from baseline in vital sign measurements
Time frame: approximately 25 weeks
Blood pressure and heart rate
TMC278 LA safety and tolerability parameters including the collection of adverse events
Time frame: approximately 12 weeks
TMC278 LA safety and tolerability parameters including change from baseline in clinical laboratory safety assessments
Time frame: approximately 12 weeks
Hematology, Clinical Chemistry and Urinalysis
TMC278 LA safety and tolerability parameters including change from baseline in ECG measurements
Time frame: approximately 12 weeks
TMC278 LA safety and tolerability parameters including change from baseline in vital sign measurements
Time frame: approximately 12 weeks
Blood pressure and heart rate
Composite of PK parameters following single and repeat dose intramuscular or subcutaneous administration
Time frame: approximately 25 weeks
Measurements include: area under the plasma concentration time curve over the dosing interval (AUC(0-t)), maximum observed concentration (Cmax), time to maximum observed concentration (tmax), concentration at the end of the dosing interval (Ct).
Composite of GSK1265744 pharmacokinetic parameters following repeat dose oral administration
Time frame: approximately 25 weeks
Measurements include: area under the plasma concentration time curve over the dosing interval (AUC(0-t)), maximum observed concentration (Cmax), time to maximum observed concentration (tmax), concentration at the end of the dosing interval (Ct).
Composite of TMC278 LA pharmacokinetic parameters following single and repeat dose intramuscular administration
Time frame: approximately 12 weeks
Measurements include: area under the plasma concentration time curve over the dosing interval (AUC(0-t)), maximum observed concentration (Cmax), time to maximum observed concentration (tmax), concentration at the end of the dosing interval (Ct).
GSK1265744 LAP safety and tolerability parameters including change from baseline for clinical chemistry assessments (ALT, AST, ALP, Total and Direct Bilirubin).
Time frame: 52 weeks
8 secondary outcomes
GSK1265744 oral formulation safety and tolerability parameters including the collection of adverse events
Time frame: 21 days
GSK1265744 oral formulation safety and tolerability parameters including change from baseline in clinical laboratory safety assessments
Time frame: 21 days
GSK1265744 oral formulation safety and tolerability parameters including change from baseline in ECG measurements
Time frame: 21 days
GSK1265744 oral formulation safety and tolerability parameters including change from baseline in vital sign measurements
Time frame: 21 days
Composite of PK parameters of GSK1265744 LAP and TMC278 LA
Time frame: approximately 12 weeks
Composite of PK parameters following each dose administration at different dose levels for the assessment of dose proportionality and relative exposure
Time frame: approximately 25 weeks
Composite of PK parameters for GSK1265744 LAP
Time frame: approximately 25 weeks
Composite of PK parameters of TMC278 LA
Time frame: approximately 12 weeks
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 10 Feb 2014.
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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.
GSK Clinical Trials study director
ViiV Healthcare
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GSK1265744 Oral, GSK1265744 LAP 800mg intramuscular injection and GSK1265744 LAP 200mg subcutaneous injection in people with Infection, Human Immunodeficiency Virus, run by ViiV Healthcare at 2 sites in United States.
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 6 inclusion and 18 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 10 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 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.
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?
GSK1265744 LAP safety and tolerability parameters including the collection of adverse events (time frame: approximately 25 weeks). The study lists 12 primary outcomes in all. 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 10 Feb 2014.