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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Janssen Pharmaceuticals
GlaxoSmithKline
Information provided by (Responsible Party):
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT02120352
First received: April 17, 2014
Last updated: October 16, 2014
Last verified: September 2014
  Purpose

This study is a Phase IIb, randomized, multicentre, parallel group, open-label, study having an overall objective to evaluate the antiviral activity, tolerability, and safety of two intramuscular (IM) dosing regimens of GSK744 LA plus TMC278 LA, relative to GSK744 30 milligram (mg) plus Abacavir/Lamivudine (ABC/3TC) given orally once daily (QD), in HIV-1 infected antiretroviral-naïve subjects. GSK744 is the oral formulation of GSK1265744, GSK744 LA is the long acting injectable formulation of GSK1265744 and TMC278 LA is the long acting injectable formulation of TMC278.

The study will consist of three parts: an Induction Period, Maintenance Period and Extension Period. There is also a Long-Term Follow Up Period for subjects who withdraw from the study and have received at least one dose of GSK744 LA and / or TMC278 LA. In the Induction Period, eligible subjects will receive a combination of an oral regimen of 30 mg of GSK744 and 600/300 mg of ABC/3TC, once daily for 20 weeks. In the Maintenance Period, eligible subjects will be randomized 2:2:1 at Day 1 to receive an IM regimen of GSK744 LA 400 mg + TMC278 LA 600 mg every 4 weeks for 96 weeks (Q4W), an IM regimen of GSK744 LA 600 mg + TMC278 LA 900 mg every 8 weeks for 96 weeks (Q8W), or to continue on the oral Induction Period regimen of GSK744 30 mg + ABC/3TC once daily for 96 weeks (or 104 weeks if continuing on to the Extension Period). The Extension Period will allow for a collection of longer term efficacy and safety and tolerability data from subjects receiving GSK744 LA and TMC278 LA.

The study will involve sufficient subjects at screening in order to ensure a total of approximately 265 subjects at the beginning of the Induction Period and approximately 225 subjects randomized into the Maintenance Period.


Condition Intervention Phase
Infection, Human Immunodeficiency Virus
Drug: GSK744
Drug: GSK744 LA
Drug: TMC278 LA
Drug: ABC/3TC
Drug: RPV
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase IIb Study Evaluating a Long-Acting Intramuscular Regimen of GSK1265744 Plus TMC278 For The Maintenance of Virologic Suppression Following an Induction of Virologic Suppression on an Oral Regimen of GSK1265744 Plus Abacavir/Lamivudine in HIV-1 Infected, Antiretroviral Therapy-Naive Adult Subjects

Resource links provided by NLM:


Further study details as provided by ViiV Healthcare:

Primary Outcome Measures:
  • The proportion of subjects with HIV-1 Ribonucleic acid (RNA) <50 copies/millilitre (c/mL) at Maintenance Week 32 [ Time Frame: Week 32 ] [ Designated as safety issue: No ]
    The endpoint at Week 32 is based on the ITT-Maintenance Exposed population using the MSDF (Missing, Switch or Discontinuation = Failure) (Snapshot) algorithm.

  • The proportion of subjects with protocol defined virologic failures over time [ Time Frame: Up to Week 96/Withdrawal ] [ Designated as safety issue: No ]
    Virologic failure is defined as any of the following: Non-response as indicated by a less than a 1.0 log10 copies/mL decrease in plasma HIV-1 RNA after 4 weeks of starting the Induction Period (subsequently confirmed, unless the plasma HIV-1 RNA is <400 c/mL). Rebound as indicated by two consecutive plasma HIV-1 RNA levels >=200 c/mL after prior suppression to < 200 c/mL. Rebound as indicated by two consecutive plasma HIV-1 RNA that are > 0.5 log10 c/mL increase in plasma HIV-1 RNA from the nadir value on study, where the lowest HIV-1 RNA value is >=200 c/mL.

  • Incidence and severity of adverse events (AEs) over time [ Time Frame: Up to Week 96/Withdrawal ] [ Designated as safety issue: No ]
    An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product

  • Incidence and severity of laboratory abnormalities over time [ Time Frame: Up to Week 96/Withdrawal ] [ Designated as safety issue: No ]
    Laboratory tests will include haematology, clinical chemistry, and urinalysis parameters.


Secondary Outcome Measures:
  • Proportion of subjects with plasma HIV-1 RNA <200 c/mL and <50 c/mL, for oral dose of GSK744 30 mg plus ABC/3TC [ Time Frame: Up to Week 96/Withdrawal ] [ Designated as safety issue: No ]
    The antiviral activity of GSK744 30 mg plus ABC/3TC orally once daily will be evaluated, through the Induction and Maintenance Periods.

  • Absolute values and change from Baseline in plasma HIV-1 RNA, for oral dose of GSK744 30 mg plus ABC/3TC [ Time Frame: Baseline to Week 96 ] [ Designated as safety issue: No ]
    The antiviral activity of GSK744 30 mg plus ABC/3TC oral once daily, by measuring the absolute values and change from Baseline in plasma HIV-1 RNA will be evaluated, through the Induction and Maintenance Periods.

  • Absolute values and changes from Baseline in CD4+ cell counts, for oral dose of GSK744 30 mg plus ABC/3TC [ Time Frame: Baseline to Week 96 ] [ Designated as safety issue: No ]
    The antiviral activity of GSK744 30 mg plus ABC/3TC orally once daily will be evaluated, by measuring the absolute values and change from Baseline in CD4+ cell counts, through the Induction and Maintenance Periods.CD4+ lymphocyte count will be obtained by flow cytometry

  • Incidence of disease progression for oral dose of GSK744 30 mg plus ABC/3TC [ Time Frame: Up to Week 96/Withdrawal ] [ Designated as safety issue: No ]
    The incidence will be evaluated using indicators of clinical disease progression including HIV-associated conditions, acquired immunodeficiency syndrome [AIDS] and death after administration of oral dose of GSK744 30 mg plus ABC/3TC

  • Incidence and severity of AEs over time, for oral dose of GSK744 30 mg plus ABC/3TC [ Time Frame: Up to Week 96/Withdrawal ] [ Designated as safety issue: No ]
    An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

  • The incidence and severity of laboratory abnormalities over time, for oral dose of GSK744 30 mg plus ABC/3TC [ Time Frame: Up to Week 96/Withdrawal ] [ Designated as safety issue: No ]
    Laboratory tests will include haematology, clinical chemistry, and urinalysis parameters.

  • Absolute values and changes in laboratory parameters over time, for oral dose of GSK744 30 mg plus ABC/3TC [ Time Frame: Up to Week 96/Withdrawal ] [ Designated as safety issue: No ]
    Laboratory tests will include haematology, clinical chemistry, and urinalysis parameters.

  • Proportion of subjects with plasma HIV-1 RNA <200 c/mL and <50 c/mL over time, for GSK744 LA 400 mg IM plus TMC278 LA 600 mg IM every 4 weeks and GSK744 LA 600 mg IM plus TMC278 LA 900 mg every 8 weeks, relative to GSK744 plus ABC/3TC orally once daily [ Time Frame: Up to Week 96/Withdrawal ] [ Designated as safety issue: No ]
    The efficacy, tolerability, and safety will be evaluated through Week 96 of the Maintenance Period. Plasma HIV-1 RNA will be measured by ABBOTT REALTIME™ HIV-1 Assay with LLOD of 40 c/mL. Additional exploratory methods may be used in some cases. ABBOTT REALTIME is a trademark owned by Abbott Laboratories.

  • Proportion of subjects with protocol defined virologic failures over time, for GSK744 LA 400 mg IM plus TMC278 LA 600 mg IM every 4 weeks and GSK744 LA 600 mg IM plus TMC278 LA 900 mg every 8 weeks, relative to GSK744 30 mg plus ABC/3TC orally once daily [ Time Frame: Up to Week 96/Withdrawal ] [ Designated as safety issue: No ]
    Virologic failure is defined as any of the following: Non-response indicated by a less than a 1.0 log10 copies/mL decrease in plasma HIV-1 RNA after 4 weeks of starting the Induction Period (subsequently confirmed, unless the plasma HIV-1 RNA is <400 c/mL). Rebound as indicated by two consecutive plasma HIV-1 RNA levels >=200 c/mL after prior suppression to < 200 c/mL. Rebound as indicated by two consecutive plasma HIV-1 RNA that are > 0.5 log10 c/mL increase in plasma HIV-1 RNA from the nadir value on study, where the lowest HIV-1 RNA value is >=200 c/mL.

  • The absolute values and change from Baseline in plasma HIV-1 RNA, for GSK744 LA 400 mg IM plus TMC278 LA 600 mg IM every 4 weeks and GSK744 LA 600 mg IM plus TMC278 LA 900 mg every 8 weeks, relative to GSK744 30 mg plus ABC/3TC orally once daily [ Time Frame: Up to Week 96/Withdrawal ] [ Designated as safety issue: No ]
    Plasma HIV-1 RNA will be measured by Abbott Real time HIV-1 Assay with LLOD of 40 c/mL. Additional exploratory methods may be used in some cases.

  • Absolute values and changes from Baseline in CD4+ cell counts, for GSK744 LA 400 mg IM plus TMC278 LA 600 mg IM every 4 weeks and GSK744 LA 600 mg IM plus TMC278 LA 900 mg every 8 weeks, relative to GSK744 30 mg plus ABC/3TC orally once daily [ Time Frame: Up to Week 96/Withdrawal ] [ Designated as safety issue: No ]
    CD4+ lymphocyte count will be obtained by flow cytometry

  • The incidence of disease progression for GSK744 LA 400 mg IM plus TMC278 LA 600 mg IM every 4 weeks and GSK744 LA 600 mg IM plus TMC278 LA 900 mg every 8 weeks, relative to GSK744 30 mg plus ABC/3TC orally once daily [ Time Frame: Up to Week 96/Withdrawal ] [ Designated as safety issue: No ]
    The incidence will be evaluated using indicators of clinical disease progression including HIV-associated conditions, AIDS and death.

  • Incidence of disease progression through Week 96 of the Maintenance Period. [ Time Frame: Up to Week 96/Withdrawal ] [ Designated as safety issue: No ]
    The incidence will be evaluated using indicators of clinical disease progression including HIV-associated conditions, AIDS and death

  • Incidence and severity of AEs, for GSK744 LA 400 mg IM plus TMC278 LA 600 mg IM every 4 weeks and GSK744 LA 600 mg IM plus TMC278 LA 900 mg every 8 weeks, relative to GSK744 30 mg plus ABC/3TC orally once daily [ Time Frame: Up to Week 96/Withdrawal ] [ Designated as safety issue: No ]
    An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product

  • Incidence and severity of laboratory abnormalities, for GSK744 LA 400 mg IM plus TMC278 LA 600 mg IM every 4 weeks and GSK744 LA 600 mg IM plus TMC278 LA 900 mg every 8 weeks, relative to GSK744 30 mg plus ABC/3TC orally once daily [ Time Frame: Up to Week 96/Withdrawal ] [ Designated as safety issue: No ]
    Laboratory tests will include haematology, clinical chemistry, ECGs, and urinalysis parameters

  • Absolute values and changes in laboratory parameters, for GSK744 LA 400 mg IM plus TMC278 LA 600 mg IM every 4 weeks and GSK744 LA 600 mg IM plus TMC278 LA 900 mg every 8 weeks, relative to GSK744 30 mg plus ABC/3TC orally once daily [ Time Frame: Up to Week 96/Withdrawal ] [ Designated as safety issue: No ]
    Laboratory tests will include haematology, clinical chemistry, ECGs, and urinalysis parameters

  • Plasma pharmacokinetic (PK) parameters for GSK744 LA and TMC278 LA during the Maintenance Period [ Time Frame: Up to Week 96/Withdrawal ] [ Designated as safety issue: No ]
    PK parameters included (C trough and concentrations post dose [~Cmax])

  • Plasma GSK744 and RPV trough concentrations [ Time Frame: Up to Week 96/Withdrawal ] [ Designated as safety issue: No ]
    To determine when steady state is achieved for each GSK744 LA and TMC278 LA regimen Concentrations of GSK1265744 and TMC278 will be determined in plasma samples.

  • PK-pharmacodynamic (PD) assessment for GSK744 LA and TMC278 LA [ Time Frame: Up to Week 48 ] [ Designated as safety issue: No ]
    The PK-PD relationship will be explored between plasma PK parameters and plasma HIV-1 RNA, CD4+ cell counts and/or occurrence of AEs through Week 48 of the Maintenance Period.

  • Incidence of treatment emergent genotypic and phenotypic resistance to GSK1265744, TMC278, and other on-study Antiretroviral Therapy (ART). [ Time Frame: Up to Week 96/Withdrawal ] [ Designated as safety issue: No ]
    The development of viral resistance will be assessed in subjects experiencing protocol defined virologic failure.

  • The proportion of subjects with plasma HIV-1 RNA <50 c/mL over time. [ Time Frame: Up to Week 96/Withdrawal ] [ Designated as safety issue: No ]
    The effect of various demographic Baseline characteristics and adherence on virologic response of GSK1265744 and TMC278 will be explored. Plasma HIV-1 RNA will be measured by Abbott Real time HIV-1 Assay with LLOD of 40 c/mL. Additional exploratory methods may be used in some cases.

  • To evaluate the treatment satisfaction for subjects on the long-acting injectable regimens with those on the oral regimen using the HIV Treatment Satisfaction Questionnaire Status (HIVTSQ(s)), through Week 96 of the Maintenance Period. [ Time Frame: Up to Week 96/Withdrawal ] [ Designated as safety issue: No ]
    The HIV Treatment Satisfaction Questionnaire (HIVTSQ) will assess change in treatment satisfaction over time (in the same subjects) and compare current satisfaction with previous treatment satisfaction, from an earlier time point. HIVTSQ(s) is the status version of the questionnaire.

  • To evaluate the change in treatment satisfaction for subjects using the HIV Treatment Satisfaction Questionnaire Change (HIVTSQ[c]) through Week 32 of the Maintenance Period. [ Time Frame: Up to Week 32 ] [ Designated as safety issue: No ]
    HIVTSQ will assess change in treatment satisfaction over time (in the same subjects) and compare current satisfaction with previous treatment satisfaction, from an earlier time point. HIVTSQ(c) is the revised changed version.

  • To evaluate medication adherence over time using the HIV Medication Questionnaire (HIVMQ). [ Time Frame: Up to Week 96/Withdrawal ] [ Designated as safety issue: No ]
    HIVMQ is used to assess medication adherence as reported by the subjects.


Estimated Enrollment: 265
Study Start Date: April 2014
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GSK744 LA 600 mg + TMC278 LA 900 mg every 8 weeks (Q8W)
In the Induction Period of 20 weeks, subjects will receive an oral regimen of GSK744 30 mg once daily plus ABC/3TC 600/300 mg once daily. In the last 4 weeks of the Induction Period subject will also receive RPV 25 mg tablet once daily. In the Maintenance Period, subject will receive following IM doses: Day 1 only - GSK744 LA 800 mg (loading dose delivered as two 400 mg IM injections) + TMC278 LA 900 mg IM. Week 4 only - GSK744 LA 600 mg IM (second loading dose, no TMC278).Week 8 - GSK744 LA 600 mg IM + TMC278 LA 900 mg IM every 8 weeks for 96 weeks.
Drug: GSK744 LA
Sterile white to slightly colored suspension containing 200 mg/mL of GSK744 as free acid (GSK1265744 free acid), polysorbate 20, polyethylene glycol 3350, mannitol, and water for injection, packaged in a 3 mL USP Type I glass vial, for administration by IM injection
Drug: TMC278 LA
Sterile white suspension containing 300 mg/mL of TMC278 as free base, poloxamer 338, sodium dihydrogen phosphate monohydrate, citric acid monohydrate, glucose monohydrate, sodium hydroxide, water for injection, packaged in a 2 mL USP Type I glass vial, for administration by IM injection.
Drug: RPV
Off-white, round, biconvex, film-coated 25 mg Rilpivirine (RPV) tablets for oral administration. It will be co-administered with GSK744+ABC/3TC, from Week (-4) through Day 1, during the Induction Period. Eligible subjects switching from the oral regimen to the IM regimen in the Extension Period will receive 2 weeks of RPV 25 mg once daily, from Week 102 through Week 104
Experimental: GSK744 LA 400 mg + TMC278 LA 600 mg every 4 weeks (Q4W)
In the Induction Period of 20 weeks, subjects will receive an oral regimen of GSK744 30 mg once daily plus ABC/3TC 600/300 mg once daily. In the last 4 weeks of the Induction Period subjects will also receive RPV 25 mg tablet once daily. In the Maintenance Period, subjects will receive following IM doses: Day 1 only - GSK744 LA 800 mg (loading dose delivered as two 400 mg IM injections) + TMC278 LA 600 mg IM. Week 4 - GSK744 LA 400 mg IM + TMC278 LA 600 mg IM every 4 weeks for 96 weeks
Drug: GSK744 LA
Sterile white to slightly colored suspension containing 200 mg/mL of GSK744 as free acid (GSK1265744 free acid), polysorbate 20, polyethylene glycol 3350, mannitol, and water for injection, packaged in a 3 mL USP Type I glass vial, for administration by IM injection
Drug: TMC278 LA
Sterile white suspension containing 300 mg/mL of TMC278 as free base, poloxamer 338, sodium dihydrogen phosphate monohydrate, citric acid monohydrate, glucose monohydrate, sodium hydroxide, water for injection, packaged in a 2 mL USP Type I glass vial, for administration by IM injection.
Drug: RPV
Off-white, round, biconvex, film-coated 25 mg Rilpivirine (RPV) tablets for oral administration. It will be co-administered with GSK744+ABC/3TC, from Week (-4) through Day 1, during the Induction Period. Eligible subjects switching from the oral regimen to the IM regimen in the Extension Period will receive 2 weeks of RPV 25 mg once daily, from Week 102 through Week 104
Active Comparator: Oral Control Arm
In the Induction Period of 20 weeks, subjects will receive an oral regimen of GSK744 30 mg once daily plus ABC/3TC 600/300 mg once daily. In the last 4 weeks of the Induction Period subjects will also receive RPV 25 mg tablet once daily. In the Maintenance Period, subjects will receive an oral regimen of 30 mg of GSK744 and ABC/3TC once daily for 96 weeks (or 104 weeks if going on to the Extension Period)
Drug: GSK744
White to almost white oval shaped film coated 30 mg tablets for oral administration.
Drug: ABC/3TC
ABC/3TC fixed dose combination (FDC) oral tablet, containing 600 mg of ABC (as abacavir sulfate) and 300 mg of 3TC
Drug: RPV
Off-white, round, biconvex, film-coated 25 mg Rilpivirine (RPV) tablets for oral administration. It will be co-administered with GSK744+ABC/3TC, from Week (-4) through Day 1, during the Induction Period. Eligible subjects switching from the oral regimen to the IM regimen in the Extension Period will receive 2 weeks of RPV 25 mg once daily, from Week 102 through Week 104

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects screened for this study must be HIV-1 infected and >=18 years of age.
  • A female subject is eligible to enter and participate in the study if she: is of non-child-bearing potential defined as either post-menopausal (12 months of spontaneous amenorrhea and >=45 years of age) or physically incapable of becoming pregnant with documented tubal ligation, hysterectomy or bilateral oophorectomy or; is of child-bearing potential with a negative pregnancy test at both Screening and first day of the Induction Period and agrees to use one of the following methods of contraception to avoid pregnancy 2 weeks prior to administration of IP, throughout the study, and for at least 2 weeks after discontinuation of all oral study medications and for at least 52 weeks after discontinuation of GSK744 LA and TMC278 LA: Complete abstinence from intercourse (where this is the subject's preferred and usual lifestyle); double barrier method (male condom/spermicide, male condom/diaphragm, diaphragm/spermicide); approved hormonal contraception; any intrauterine device (IUD) with published data showing that the expected failure rate is <1% per year; male partner sterilization prior to the female subject's entry into the study, and this male is the sole partner for that subject; any other method with published data showing that the lowest expected failure rate is <1% per year; any contraception method must be used consistently and in accordance with the approved product label. All subjects participating in the study must follow safer sexual practices including the use of effective barrier methods (e.g. male condom/spermicide) to minimize risk of HIV transmission.
  • HIV-1 infection as documented by Screening plasma HIV-1 RNA>=1000 c/mL.
  • CD4+ cell count >=200 cells/mm^3 (or higher as local guidelines dictate).
  • ART-naive defined as having no more than 10 days of prior therapy with any antiretroviral agent following a diagnosis of HIV-1 infection. Any previous exposure to an HIV integrase inhibitor or non-nucleoside reverse transcriptase inhibitor will be exclusionary.
  • French subjects: In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.

Exclusion Criteria:

  • Women who are breastfeeding.
  • Any evidence at screening of an active Center for Disease and Prevention Control (CDC) Category C disease, except cutaneous Kaposi's sarcoma not requiring systemic therapy.
  • Subjects with known moderate to severe hepatic impairment.
  • Any pre-existing physical or mental condition (including substance abuse disorder) which, in the opinion of the Investigator, may interfere with the subject's ability to comply with the dosing schedule and/or protocol evaluations or which may compromise the safety of the subject.
  • Subject who, in the investigator's judgment, poses a significant suicide risk. Recent history of suicidal behavior and/or suicidal ideation may be considered as evidence of serious suicide risk.
  • The subject has a tattoo or other dermatological condition overlying the gluteus region which may interfere with interpretation of injection site reactions.
  • History of ongoing or clinically relevant hepatitis within the previous 6 months, including chronic Hepatitis B virus (HBV) infection (HBsAg positive). Asymptomatic individuals with chronic hepatitis C virus (HCV) infection will not be excluded, however Investigators must carefully assess if therapy specific for HCV infection is required; subjects who are anticipated to require such therapy during the randomized portion of the study must be excluded.
  • History of liver cirrhosis with or without hepatitis viral co-infection.
  • Ongoing or clinically relevant pancreatitis.
  • History of the following cardiac diseases: myocardial infarction, congestive heart failure, documented hypertrophic cardiomyopathy, sustained ventricular tachycardia.
  • Personal or known family history of prolonged QT syndrome.
  • Any condition which, in the opinion of the Investigator, may interfere with the absorption, distribution, metabolism or excretion of the drug or render the subject unable to receive study medication.
  • History or presence of allergy or intolerance to the study drugs or their components or drugs of their class. In addition, if heparin is used during PK sampling, subjects with a history of sensitivity to heparin or heparin-induced thrombocytopenia must not be enrolled.
  • Current or anticipated need for chronic anti-coagulation.
  • Any evidence of primary resistance based on the presence of any major resistance-associated mutation in the Screening result or, if known, any historical resistance test result.
  • Any verified Grade 4 laboratory abnormality.
  • Any acute laboratory abnormality at Screening, which, in the opinion of the Investigator, would preclude the subject's participation in the study of an investigational compound.
  • Subject has estimated creatinine clearance <50 mL/min via Cockcroft-Gault method.
  • Alanine aminotransferase (ALT) >=5 times Upper limit of normal (ULN). Subjects with ALT >2xULN but <5xULN may participate in the study, if in the opinion of the Investigator and GlaxoSmithKline (GSK) medical monitor the lab abnormality will not interfere with the study procedures or compromise subject safety.
  • Alanine aminotransferase (ALT) >=3xULN and bilirubin >=1.5xULN (with >35% direct bilirubin).
  • Any clinically significant finding on screening or Baseline electrocardiograph (ECG), specifically: Heart rate <45 and >100 beats per minute (bpm) (Males) and <50 and >100 bpm (Females) (100 to 110 bpm can be rechecked within 30 minutes to verify eligibility), QRS duration >120 milliseconds (msec), QTc interval (B or F) >450 msec; non-sustained (>=3 consecutive beats) or sustained ventricular tachycardia; sinus pauses >2.5 seconds; 2nd degree (Type II) or higher atrio-ventricular (AV) block; evidence of WPW (Wolff- Parkinson-White) syndrome (ventricular pre-excitation); pathologic Q waves defined as Q wave >40msec OR depth >0.4 mV; any significant arrhythmia (either on ECG or by history) which, in the opinion of the Investigator and GSK medical monitor, will interfere with the safety for the individual subject.
  • Subjects who are human leukocyte antigen (HLA)-B*5701 positive and unable to use an alternative nucleoside reverse transcriptase inhibitor (NRTI) backbone (subjects who are HLA-B*5701 positive may be enrolled if they use an alternative NRTI backbone that does not contain abacavir).
  • Exposure to an experimental drug and/or experimental vaccine within 28 days or 5 half-lives of the test agent, or twice the duration of the biological effect of the test agent, whichever is longer, prior to the first dose of IP.
  • Treatment with any of the following agents within 28 days of Screening; radiation therapy, cytotoxic chemotherapeutic agents, tuberculosis therapy and Immunomodulators that alter immune responses (such as systemic corticosteroids, interleukins, or interferons)
  • Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening.
  • Treatment with any agent, except recognized ART as allowed above, with documented activity against HIV-1 within 28 days of the first dose of IP.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02120352

  Show 53 Study Locations
Sponsors and Collaborators
ViiV Healthcare
Janssen Pharmaceuticals
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials ViiV Healthcare
  More Information

No publications provided

Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT02120352     History of Changes
Other Study ID Numbers: 200056
Study First Received: April 17, 2014
Last Updated: October 16, 2014
Health Authority: Spain: AGENCIA ESPAÑOLA DE MEDICAMENTO Y PRODUCTOS SANITARIOS (AEMPS)
Germany: Federal Institute for Drugs and Medical Devices
United States: Food and Drug Administration
Canada: Health Canada
France: Agence Nationale de Sécurité du Médicament

Keywords provided by ViiV Healthcare:
abacavir
every other month
once daily
TMC278 LA
bi-monthly
GSK1265744
lamivudine
TMC278
GSK744
induction
rilpivirine
HIV-1 infection
RPV
injectable
integrase inhibitor
treatment satisfication
long acting
maintenance
non-nucleoside reverse transcriptase inhibitor
LA
adherence
once monthly
therapy-naive

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Infection
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Abacavir
Lamivudine
Reverse Transcriptase Inhibitors
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014