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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 309
- 试验地点
- 1
- 主要终点
- Number of Participants With Maximum Post-Baseline Emergent Toxicities for Clinical Chemistry Parameters
研究概览
简要总结
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 (cabotegravir), 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.
干预措施: CAB LA (Drug)
CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following intramuscular (IM) doses: Day 1 only: CAB long acting (LA) 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 900 mg IM; Week 4 only: CAB LA 600 mg IM (second loading dose, no RPV); and from Week 8: CAB LA 600 mg IM +RPV LA 900 mg IM every 8 Weeks (Q8W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.
干预措施: RPV (Drug)
CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.
干预措施: CAB LA (Drug)
CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive following IM doses: Day 1 only: CAB LA 800 mg (loading dose delivered as two 400 mg IM injections) + RPV LA 600 mg IM; and from Week 4: CAB LA 400 mg IM + RPV LA 600 mg IM every 4 Weeks (Q4W) for 96 weeks. Eligible participants had the option to continue study participation in the Extension Period.
干预措施: RPV (Drug)
CAB 30 mg+ABC/3TC QD (Induction Period)
In induction period, all participants received an oral regimen of cabotegravir (CAB) 30 milligrams (mg) once daily (QD) plus abacavir/lamivudine (ABC/3TC) 600/300 mg QD for 20 weeks. They also received an oral dose of Rilpivirine (RPV) 25 mg tablet once daily in the last 4 weeks of the Induction Period.
干预措施: CAB Oral Tablets (Drug)
CAB 30 mg+ABC/3TC QD (Induction Period)
In induction period, all participants received an oral regimen of cabotegravir (CAB) 30 milligrams (mg) once daily (QD) plus abacavir/lamivudine (ABC/3TC) 600/300 mg QD for 20 weeks. They also received an oral dose of Rilpivirine (RPV) 25 mg tablet once daily in the last 4 weeks of the Induction Period.
干预措施: ABC/3TC Oral tablets (Drug)
CAB 30 mg+ABC/3TC QD (Induction Period)
In induction period, all participants received an oral regimen of cabotegravir (CAB) 30 milligrams (mg) once daily (QD) plus abacavir/lamivudine (ABC/3TC) 600/300 mg QD for 20 weeks. They also received an oral dose of Rilpivirine (RPV) 25 mg tablet once daily in the last 4 weeks of the Induction Period.
干预措施: RPV Oral Tablets (Drug)
CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).
干预措施: CAB Oral Tablets (Drug)
CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).
干预措施: ABC/3TC Oral tablets (Drug)
CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period)
On Day 1 of the Maintenance period, participants who successfully completed the Induction period, were randomized to receive CAB and ABC/3TC QD for 96 weeks. Eligible participants had the option to continue study participation in Extension Period by switching to an optimized IM CAB LA+ RPV LA regimen of their choice (Q8W or Q4W).
干预措施: RPV Oral Tablets (Drug)
Optimized CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Extension Period)
Participants who completed 96 weeks of CAB 30 mg + ABC/3TC QD regimen in Maintenance Period transitioned to Extension Period and received an optimized loading dose of CAB LA 600 mg+RPV LA 900 mg IM at Week 100 and Week 104 followed by CAB LA 600 mg+RPV LA 900 mg IM-Q8W in the Extension Phase. Participants were followed up until end of Extension Period.
干预措施: CAB LA (Drug)
Optimized CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Extension Period)
Participants who completed 96 weeks of CAB 30 mg + ABC/3TC QD regimen in Maintenance Period transitioned to Extension Period and received an optimized loading dose of CAB LA 600 mg+RPV LA 900 mg IM at Week 100 and Week 104 followed by CAB LA 600 mg+RPV LA 900 mg IM-Q8W in the Extension Phase. Participants were followed up until end of Extension Period.
干预措施: RPV (Drug)
Optimized CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Extension Period)
Participants who completed 96 weeks of CAB 30 mg + ABC/3TC QD regimen in Maintenance Period transitioned to Extension Period and received an optimized loading dose of CAB LA 400 mg+RPV LA 900 mg IM at Week 100 followed by CAB LA 400 mg+RPV LA 900 mg IM-Q8W in the Extension Phase. Participants were followed up until end of Extension Period.
干预措施: CAB LA (Drug)
Optimized CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Extension Period)
Participants who completed 96 weeks of CAB 30 mg + ABC/3TC QD regimen in Maintenance Period transitioned to Extension Period and received an optimized loading dose of CAB LA 400 mg+RPV LA 900 mg IM at Week 100 followed by CAB LA 400 mg+RPV LA 900 mg IM-Q8W in the Extension Phase. Participants were followed up until end of Extension Period.
干预措施: RPV (Drug)
Long-Term Follow-Up Group
This group included participants that were withdrawn from CAB LA+RPV LA IM regimens based on protocol criteria and were required to access Highly Active Antiretroviral Therapy (HAART) of choice. Participants were followed up for approximately 52 weeks.
干预措施: HAART (Other)
结局指标
主要结局
Number of Participants With Maximum Post-Baseline Emergent Toxicities for Clinical Chemistry Parameters
时间窗: Up to an average of 59 weeks
Clinical chemistry parameters aspartate amino transferase (AST), alanine amino transferase (ALT), alkaline phosphatase (ALP), carbon dioxide(CO2) content/bicarbonate (HCO3), cholesterol, creatine kinase (CK), glucose, low density lipoprotein (LDL) cholesterol, lipase, potassium, and sodium, total bilirubin (TBIL) and triglycerides were evaluated. Toxicity was graded according to Division of Acquired Immunodeficiency Syndrome (DAIDS) grading criteria, where Grade 1-mild, Grade 2-moderate, Grade 3-severe, Grade 4-potentially life-threatening. Data presented includes all post-baseline treatment emergent Induction Period and MP toxicities, as well as LTFP toxicities for those participants who did not enter the extension period. Number of participants with any time post-baseline maximum emergent toxicities in any of the chemistry parameters have been presented.
Number of Participants With Post-Baseline Urinalysis Dipstick Results
时间窗: Up to an average of 59 weeks
Urinalysis dipstick included urine occult blood, urine glucose, urine ketones, urine nitrite, urine protein and urine leukocyte. The dipstick test gives results in a semi-quantitative manner and results for urinalysis parameters can be read as positive, trace, 1+, 2+ and 3+ indicating proportional concentrations in the urine sample. Data presented includes all post-baseline dipstick results during Induction and Maintenance Periods, as well as LTFP for those participants who did not enter the extension period.
Number of Participants With Post-Baseline Adverse Events by Maximum Toxicity Grade
时间窗: Up to an average of 59 weeks
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Toxicity was graded according to Division of Acquired Immunodeficiency Syndrome (DAIDS) grading criteria, where Grade 1-mild, Grade 2-moderate, Grade 3-severe, Grade 4-potentially life-threatening. Data presented includes all post-baseline treatment emergent Induction Period and MP toxicities, as well as LTFP toxicities for those participants who did not enter the extension period. Number of participants with post-Baseline adverse events by maximum toxicity Grade have been presented.
Percentage of Participants With Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) Level Below 50 Copies/Milliliter (c/mL) at Week 32
时间窗: Week 32
Percentage of participants with HIV-1 RNA\<50 c/mL was obtained using Food and Drug Administration (FDA) Snapshot algorithm. The algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as well as participants who switch their concomitant antiretroviral therapy (ART) prior to the visit of interest as non-responders. The Intent-to-Treat Maintenance Exposed (ITT-ME) Population consisted of all randomized participants who received at least one injection or one dose of investigational product during the Maintenance Period of the study (on or after Day 1 visit).
Number of Participants With Any Serious Adverse Event (SAE) and Any Non-serious Adverse Event (Non-SAE) (Maintenance Period)
时间窗: Up to an average of 59 weeks
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, important medical events which may require medical or surgical intervention, drug-induced liver injury with hyperbilirubinaemia. Data presented includes all post-baseline induction period and maintenance period adverse events, as well as long-term follow-up period adverse events for those participants who did not enter the extension period.
Number of Participants With Protocol Defined Virologic Failure (PDVF) Until Week 32
时间窗: Up to Week 32
Virologic failure was defined as any of the following: (1) Non-response as indicated by a less than 1.0 logarithm to base 10 (log10) c/mL decrease in plasma HIV-1 RNA after 4 weeks of starting the Induction Period, which is subsequently confirmed, unless the plasma HIV-1 RNA is \< 400 c/mL; (2) Rebound as indicated by two consecutive plasma HIV-1 RNA levels \>=200 c/mL after prior suppression to \< 200 c/mL; (3) 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.
Number of Participants With Any Serious Adverse Event (SAE) and Any Non-serious Adverse Event (Non-SAE) (Induction Period)
时间窗: Up to 20 weeks
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, important medical events which may require medical or surgical intervention, drug-induced liver injury with hyperbilirubinaemia.
Number of Participants With Maximum Post-Baseline Emergent Toxicities for Hematology Parameters
时间窗: Up to an average of 59 weeks
Hematology parameters hemoglobin, platelet count, total neutrophils and white blood cell count were evaluated. Toxicity was graded according to DAIDS grading criteria, where Grade 1-mild, Grade 2-moderate, Grade 3-severe, Grade 4-potentially life-threatening. Data presented includes all post-baseline treatment emergent Induction Period and MP toxicities, as well as LTFP toxicities for those participants who did not enter the extension period. Number of participants with any time post-baseline maximum emergent toxicities in any of the hematology parameters have been presented.
次要结局
- Absolute Values of Cluster of Differentiation 4+ (CD4+), for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period)(Week -20, Week -16, Week -12, Week -4, Day 1)
- Change From Baseline in Clinical Chemistry Parameter: Albumin (Induction Period)(Baseline (Week -20) and Week -16, Week -12, Week -8, Week -4, Day 1)
- Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea (Induction Period)(Baseline (Week -20) and Week -16, Week -12, Week -8, Week -4, Day 1)
- Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelets Count and White Blood Cells (WBC) Count (Induction Period)(Baseline (Week -20) and Week -16, Week -12, Week -8, Week -4, Day 1)
- Number of Participants With AEs by Their Severity Grades Over Week 32 (Maintenance Period)(Up to Week 32)
- Change From Baseline in Clinical Chemistry Parameter: Lipase at Week 32 and Week 96 (Maintenance Period)(At Week 32 and Week 96 (compared with Baseline [Week -20]))
- Change From Baseline in Hematology Parameter: Hemoglobin at Week 32 and Week 96 (Maintenance Period)(At Week 32 and Week 96 (compared with Baseline [Week -20]))
- Ctrough of RPV LA (Q8W IM Dosing) Used for Assessment of Steady State (Maintenance Period)(Pre-dose on Weeks 16, 24 and 32)
- Absolute Values of Plasma HIV-1 RNA, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period)(Week -20, Week -16, Week -12, Week -8, Week -4, Day 1)
- Number of Participants With AEs by Their Severity Grades, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period)(Up to 20 Weeks)
- Number of Participants With Maximum Post-Baseline Emergent Toxicities for Clinical Chemistry Parameters, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period)(Up to 20 weeks)
- Percentage of Participants With Plasma HIV-1 RNA <200 c/mL and <50 c/mL, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period)(Week -20, Week -16, Week -12, Week -8, Week -4, Day 1)
- Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and CK (Induction Period)(Baseline (Week -20) and Week -16, Week -12, Week -8, Week -4, Day 1)
- Change From Baseline in Clinical Chemistry Parameter: Lipase (Induction Period)(Baseline (Week -20) and Week -16, Week -12, Week -8, Week -4, Day 1)
- Change From Baseline in Hematology Parameter: Hematocrit (Induction Period)(Baseline (Week -20) and Week -16, Week -12, Week -8, Week -4, Day 1)
- Change From Baseline in Plasma HIV-1 RNA, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period)(Baseline (Week -20) and Week -16, Week -12, Week -8, Week -4, Day 1)
- Change From Baseline in CD4+, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period)(Baseline (Week -20) and Week -16, Week -12, Week -4, Day 1)
- Number of Participants With Maximum Post-Baseline Emergent Toxicities for Hematology Parameters, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period)(Up to Week 20)
- Change From Baseline in Clinical Chemistry Parameters: Total Bilirubin and Creatinine (Induction Period)(Baseline (Week -20) and Week -16, Week -12, Week -8, Week -4, Day 1)
- Change From Baseline in Hematology Parameter: Hemoglobin (Induction Period)(Baseline (Week -20) and Week -16, Week -12, Week -8, Week -4, Day 1)
- Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period)(From Day 1 up to Week 96)
- Absolute Value of CD4+ at Week 32 and Week 96 (Maintenance Period)(At Week 32 and Week 96)
- Number of Participants With HIV-1 Disease Progression Over Week 32 and Week 96 (Maintenance Period)(At Week 32 and Week 96)
- Number of Participants With AEs by Their Severity Grades Over Week 96 (Maintenance Period)(Up to Week 96)
- Change From Baseline in Hematology Parameter: Mean Corpuscle Volume (Induction Period)(Baseline (Week -20) and Week -16, Week -12, Week -8, Week -4, Day 1)
- Number of Participants With Protocol Defined Virologic Failure at Week 32 and Week 48 (Maintenance Period)(At Week 32 and Week 48)
- Absolute Value of Plasma HIV-1 RNA at Week 32 and Week 96 (Maintenance Period)(At Week 32 and Week 96)
- Change From Baseline in Plasma HIV-1 RNA at Week 32 and Week 96 (Maintenance Period)(At Week 32 and Week 96 (compared with Baseline [Week -20]))
- Change From Baseline in Clinical Chemistry Parameter: Albumin at Week 32 and Week 96 (Maintenance Period)(At Week 32 and Week 96 (compared with Baseline [Week -20]))
- Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelet Count and WBC Count at Week 32 and Week 96 (Maintenance Period)(At Week 32 and Week 96 (compared with Baseline [Week -20]))
- Change From Baseline in Hematology Parameter: Mean Corpuscle Volume at Week 32 and Week 96 (Maintenance Period)(At Week 32 and Week 96 (compared with Baseline [Week -20]))
- Change From Baseline in Hematology Parameter: Red Blood Cell Count (Induction Period)(Baseline (Week -20) and Week -16, Week -12, Week -8, Week -4, Day 1)
- Change From Baseline in CD4+ at Week 32 and Week 96 (Maintenance Period)(At Week 32 and Week 96 (compared with Baseline [Week -20]))
- Change From Baseline in Hematology Parameter: Hematocrit at Week 32 and Week 96 (Maintenance Period)(At Week 32 and Week 96 (compared with Baseline [Week -20]))
- Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and CK at Week 32 and Week 96 (Maintenance Period)(At Week 32 and Week 96 (compared with Baseline [Week -20]))
- Change From Baseline in Clinical Chemistry Parameters: Total Bilirubin and Creatinine at Week 32 and Week 96 (Maintenance Period)(At Week 32 and Week 96 (compared with Baseline [Week -20]))
- Change From Baseline in Clinical Chemistry Parameters: Total CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea at Week 32 and Week 96 (Maintenance Period)(At Week 32 and Week 96 (compared with Baseline [Week -20]))
- Average Initial Concentration (C0) and Cmax of RPV LA (Q4W IM and Q8W IM Dosing) (Maintenance Period)(Up to Week 32)
- Ctrough of CAB LA (Q4W IM Dosing) Used for Assessment of Steady State (Maintenance Period)(Pre-dose on Weeks 16, 20, 24, 28 and 32)
- Ctrough of RPV LA (Q4W IM Dosing) Used for Assessment of Steady State (Maintenance Period)(Pre-dose on Weeks 16, 20, 24, 28 and 32)
- Virologic Failure (From MSDF Algorithm) in Relation With PK Parameter (Average C0) of CAB LA and RPV LA at Week 32 (Maintenance Period)(Up to Week 32)
- Change From Baseline in Hematology Parameter: Red Blood Cell Count at Week 32 and Week 96 (Maintenance Period)(At Week 32 and Week 96 (compared with Baseline [Week -20]))
- Average Initial Concentration (C0) and Maximum Plasma Concentration (Cmax) of CAB LA (Q4W IM and Q8W IM Dosing) (Maintenance Period)(Up to Week 32)
- Trough Concentration (Ctrough) of CAB LA (Q8W IM Dosing) Used for Assessment of Steady State (Maintenance Period)(Pre-dose on Weeks 16, 24 and 32)
- Pharmacodynamic Response (HIV-1 RNA<50 c/mL) in Relation With PK Parameter (AUC[0-tau]) of CAB LA and RPV LA at Week 32 (Maintenance Period)(Up to Week 32)
- Pharmacodynamic Response (HIV-1 RNA<50 c/mL) in Relation With PK Parameter (Average C0) of CAB LA and RPV LA at Week 32 (Maintenance Period)(Up to Week 32)
- Pharmacodynamic Response (HIV-1 RNA<50 c/mL) in Relation With PK Parameter (Cmax) of CAB LA and RPV LA at Week 32 (Maintenance Period)(Up to Week 32)
- Virologic Failure (From MSDF Algorithm) in Relation With PK Parameter (Cmax) of CAB LA and RPV LA at Week 32 (Maintenance Period)(Up to Week 32)
- Number of Participants With Treatment-emergent Phenotypic Resistance(Up to Week 32)
- HIV Treatment Satisfaction Questionnaire - Status Version (HIVTSQ[s]) Total Score at Week 32 and Week 96 (Maintenance Period)(At Week 32 and Week 96)
- Virologic Failure (From MSDF Algorithm) in Relation With PK Parameter (AUC[0-tau]) of CAB LA and RPV LA at Week 32 (Maintenance Period)(Up to Week 32)
- Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL Over Week 32 by Subgroups (Maintenance Period)(Up to Week 32)
- Number of Participants With Treatment-emergent Genotypic Resistance(Up to Week 32)
- Percentage of Participants With Protocol Defined Virologic Failure (PDVF) at Week 32 by Subgroups(Maintenance Period)(Up to Week 32)
- Number of Participants With HIV Medication Questionnaire (HIVMQ) Item E and F Scores at Week 32 (Maintenance Period)(Week 32)
- HIV Treatment Satisfaction Questionnaire - Change Version (HIVTSQ[c]) Total Score at Week 32 (Maintenance Period)(Week 32)
- Number of Participants With HIV Medication Questionnaire (HIVMQ) Item E and F Scores at Week 96 (Maintenance Period)(Week 96)