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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2013-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Phase IIb Study to Evaluate a Long-Acting Intramuscular Regimen for Maintenance of Virologic Suppression (Following Induction With an Oral Regimen of GSK1265744 and Abacavir/Lamivudine) in Human Immunodeficiency Virus Type 1 (HIV-1) Infected, Antiretroviral Therapy-Naive Adult Subjects

NCT02120352

Infection, Human Immunodeficiency Virus HIV Infections

COMPLETED PHASE2

Study to Compare the Safety and Anti-HIV Effect of GSK1265744 Versus Placebo in HIV-1 Infected Adults (ITZ112929)

NCT00920426

Infection, Human Immunodeficiency Virus

COMPLETED PHASE2

A Healthy Volunteer And Patient Study To Assess The Safety, Tolerability And Pharmacokinetics Of GSK1265744

NCT00659191

HIV Infection

COMPLETED PHASE1

Dose Ranging Study of GSK1265744 Plus Nucleoside Reverse Transcriptase Inhibitors for Induction of Human Immunodeficiency Virus-1 (HIV-1) Virologic Suppression Followed by Virologic Suppression Maintenance by GSK1265744 Plus Rilpivirine

NCT01641809

Infection, Human Immunodeficiency Virus HIV Infections

COMPLETED PHASE2

A Study to Evaluate Pharmacokinetic (PK) and Safety of GSK1265744 in Subjects With Hepatic Impairment and Control Healthy Volunteers

NCT02354950

HIV Infections

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Infection, Human Immunodeficiency Virus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Run-in Period

Oral GSK1265744 30mg once daily for 14 days

Group Type EXPERIMENTAL

GSK1265744 Oral

Intervention Type DRUG

30mg tablet

Cohort 1

GSK1265744 LAP injection given subcutaneously once a month for 4 months

Group Type EXPERIMENTAL

GSK1265744 LAP 800mg intramuscular injection

Intervention Type DRUG

800mg Loading dose given at month 1 dose

GSK1265744 LAP 200mg subcutaneous injection

Intervention Type DRUG

200mg maintenance dose give at months 2 - 4

Cohort 2

GSK1265744 LAP injection given intramuscularly once a month for 4 months. TMC278 LA + GSK1265744 given in Month 3 and 4.

Group Type EXPERIMENTAL

GSK1265744 LAP 800mg intramuscular injection

Intervention Type DRUG

800mg Loading dose given at month 1 dose

GSK1265744 LAP 200mg intramuscular injection

Intervention Type DRUG

200mg maintenance dose given at months 2 - 4

TMC278 LA 1200mg intramuscular injection

Intervention Type DRUG

1200mg Loading dose given at month 3

TMC278 LA 600mg intramuscular injection

Intervention Type DRUG

600mg Loading dose given at month 4

Cohort 3

GSK1265744 LAP injection given intramuscularly once a month for 4 months. TMC278 LA + GSK1265744 given in Month 3 and 4.

Group Type EXPERIMENTAL

GSK1265744 LAP 800mg intramuscular injection

Intervention Type DRUG

800mg Loading dose given at month 1 dose

GSK1265744 LAP 400mg intramuscular injection

Intervention Type DRUG

400mg maintenance dose given at month 2 - 4

TMC278 LA 1200mg intramuscular injection

Intervention Type DRUG

1200mg Loading dose given at month 3

TMC278 LA 600mg intramuscular injection

Intervention Type DRUG

600mg Loading dose given at month 4

Cohort 4

GSK1265744 LAP injection given intramuscularly once every 12 weeks.

Group Type EXPERIMENTAL

GSK1265744 LAP 800mg intramuscular injection

Intervention Type DRUG

800mg dose given quarterly (once every) 12 weeks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

GSK1265744 Oral

30mg tablet

Intervention Type DRUG

GSK1265744 LAP 800mg intramuscular injection

800mg Loading dose given at month 1 dose

Intervention Type DRUG

GSK1265744 LAP 200mg subcutaneous injection

200mg maintenance dose give at months 2 - 4

Intervention Type DRUG

GSK1265744 LAP 200mg intramuscular injection

200mg maintenance dose given at months 2 - 4

Intervention Type DRUG

GSK1265744 LAP 400mg intramuscular injection

400mg maintenance dose given at month 2 - 4

Intervention Type DRUG

TMC278 LA 1200mg intramuscular injection

1200mg Loading dose given at month 3

Intervention Type DRUG

TMC278 LA 600mg intramuscular injection

600mg Loading dose given at month 4

Intervention Type DRUG

GSK1265744 LAP 800mg intramuscular injection

800mg dose given quarterly (once every) 12 weeks

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

GSK1265744 GSK1265744 GSK1265744 GSK1265744 GSK1265744 TMC278 LA TMC278 LA GSK1265744

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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).

Exclusion Criteria

* 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.
* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes