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 | Completed Phase 2 Results DMC

• 2 other identifiers: 2000562013-000783-29
• Study Type: interventional
• Target: 309
• Locations: 5 countries
• Sites: 50

Brief Summary

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.

Conditions

Infection, Human Immunodeficiency Virus; HIV Infections

Keywords

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

Outcome Measures

Primary Outcomes (8)

• Percentage of Participants With Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) Level Below 50 Copies/Milliliter (c/mL) at 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).

  Week 32

• Number of Participants With Protocol Defined Virologic Failure (PDVF) Until 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.

  Up to Week 32

• Number of Participants With Any Serious Adverse Event (SAE) and Any Non-serious Adverse Event (Non-SAE) (Induction Period)

  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.

  Up to 20 weeks

• Number of Participants With Any Serious Adverse Event (SAE) and Any Non-serious Adverse Event (Non-SAE) (Maintenance Period)

  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.

  Up to an average of 59 weeks

• Number of Participants With Post-Baseline Adverse Events by Maximum Toxicity Grade

  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.

  Up to an average of 59 weeks

• Number of Participants With Maximum Post-Baseline Emergent Toxicities for Clinical Chemistry Parameters

  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.

  Up to an average of 59 weeks

• Number of Participants With Maximum Post-Baseline Emergent Toxicities for Hematology Parameters

  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.

  Up to an average of 59 weeks

• Number of Participants With Post-Baseline Urinalysis Dipstick Results

  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.

  Up to an average of 59 weeks

Secondary Outcomes (57)

• 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

• 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

• 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

• 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 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

Study Arms (7)

CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period)

EXPERIMENTAL

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.

Drug: CAB LA; Drug: RPV

CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period)

EXPERIMENTAL

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.

Drug: CAB LA; Drug: RPV

CAB 30 mg+ABC/3TC QD (Induction Period)

ACTIVE COMPARATOR

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.

Drug: CAB Oral Tablets; Drug: ABC/3TC Oral tablets; Drug: RPV Oral Tablets

CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period)

ACTIVE COMPARATOR

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).

Drug: CAB Oral Tablets; Drug: ABC/3TC Oral tablets; Drug: RPV Oral Tablets

Optimized CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Extension Period)

EXPERIMENTAL

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.

Drug: CAB LA; Drug: RPV

Optimized CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Extension Period)

EXPERIMENTAL

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.

Drug: CAB LA; Drug: RPV

Long-Term Follow-Up Group

OTHER

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.

Other: HAART

Interventions

CAB Oral Tablets DRUG

White to almost white oval shaped film coated 30 mg tablets for oral administration.

CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period); CAB 30 mg+ABC/3TC QD (Induction Period)

CAB LA DRUG

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

CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period); CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period); Optimized CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Extension Period); Optimized CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Extension Period)

ABC/3TC Oral tablets DRUG

ABC/3TC fixed dose combination (FDC) oral tablet, containing 600 mg of ABC (as abacavir sulfate) and 300 mg of 3TC

CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period); CAB 30 mg+ABC/3TC QD (Induction Period)

RPV Oral Tablets DRUG

Off-white, round, biconvex, film-coated 25 mg Rilpivirine (RPV) tablets for oral administration. 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

CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period); CAB 30 mg+ABC/3TC QD (Induction Period)

HAART OTHER

Higly-active antiretroviral therapy chosen by participant based on investigator recommendations and based on availability.

Long-Term Follow-Up Group

RPV DRUG

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.

CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period); CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period); Optimized CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Extension Period); Optimized CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Extension Period)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• ViiV Healthcare: lead
• Janssen Pharmaceuticals: collaborator
• GlaxoSmithKline: collaborator

Study Sites (50)

GSK Investigational Site

Birmingham, Alabama, 35294, United States

Location

GSK Investigational Site

Bakersfield, California, 93301, United States

Location

GSK Investigational Site

Beverly Hills, California, 90211, United States

Location

GSK Investigational Site

Long Beach, California, 90813, United States

Location

GSK Investigational Site

Los Angeles, California, 90069, United States

Location

GSK Investigational Site

Denver, Colorado, 80246, United States

Location

GSK Investigational Site

Fort Lauderdale, Florida, 33316, United States

Location

GSK Investigational Site

Ft. Pierce, Florida, 34982, United States

Location

GSK Investigational Site

Savannah, Georgia, 31401, United States

Location

GSK Investigational Site

Minneapolis, Minnesota, 55415, United States

Location

GSK Investigational Site

Omaha, Nebraska, 68198, United States

Location

GSK Investigational Site

Chapel Hill, North Carolina, 27514, United States

Location

GSK Investigational Site

Providence, Rhode Island, 02904, United States

Location

GSK Investigational Site

Austin, Texas, 78705, United States

Location

GSK Investigational Site

Dallas, Texas, 75246, United States

Location

GSK Investigational Site

Vancouver, British Columbia, V6Z 2C7, Canada

Location

GSK Investigational Site

Winnipeg, Manitoba, R3A 1R9, Canada

Location

GSK Investigational Site

Ottawa, Ontario, K1H 8L6, Canada

Location

GSK Investigational Site

Toronto, Ontario, M5G 1K2, Canada

Location

GSK Investigational Site

Montreal, Quebec, H2L 4E9, Canada

Location

GSK Investigational Site

Montreal, Quebec, H2L 4P9, Canada

Location

GSK Investigational Site

Montreal, Quebec, H3A 1T1, Canada

Location

GSK Investigational Site

Montreal, Quebec, H4A 3J1, Canada

Location

GSK Investigational Site

Bobigny, 93009, France

Location

GSK Investigational Site

Lyon, 69437, France

Location

GSK Investigational Site

Marseille, 13274, France

Location

GSK Investigational Site

Nantes, 44093, France

Location

GSK Investigational Site

Nice, 06202, France

Location

GSK Investigational Site

Paris, 75018, France

Location

GSK Investigational Site

Paris, 75571, France

Location

GSK Investigational Site

Paris, 75970, France

Location

GSK Investigational Site

Saint-Denis, 93205, France

Location

GSK Investigational Site

Munich, Bavaria, 80337, Germany

Location

GSK Investigational Site

Frankfurt am Main, Hesse, 60596, Germany

Location

GSK Investigational Site

Hanover, Lower Saxony, 30625, Germany

Location

GSK Investigational Site

Bonn, North Rhine-Westphalia, 53127, Germany

Location

GSK Investigational Site

Berlin, 10439, Germany

Location

GSK Investigational Site

Berlin, 10787, Germany

Location

GSK Investigational Site

Berlin, 13353, Germany

Location

GSK Investigational Site

Hamburg, 20146, Germany

Location

GSK Investigational Site

Hamburg, 20246, Germany

Location

GSK Investigational Site

Badalona, 08916, Spain

Location

GSK Investigational Site

Barcelona, 08025, Spain

Location

GSK Investigational Site

Barcelona, 08036, Spain

Location

GSK Investigational Site

Barcelona, 08907, Spain

Location

GSK Investigational Site

Elche, ?03203, Spain

Location

GSK Investigational Site

Madrid, 28007, Spain

Location

GSK Investigational Site

Madrid, 28040, Spain

Location

GSK Investigational Site

Madrid, 28041, Spain

Location

GSK Investigational Site

Madrid, 28046, Spain

Location

Related Publications (6)

• Kerrigan D, Mantsios A, Gorgolas M, Montes ML, Pulido F, Brinson C, deVente J, Richmond GJ, Beckham SW, Hammond P, Margolis D, Murray M. Experiences with long acting injectable ART: A qualitative study among PLHIV participating in a Phase II study of cabotegravir + rilpivirine (LATTE-2) in the United States and Spain. PLoS One. 2018 Jan 5;13(1):e0190487. doi: 10.1371/journal.pone.0190487. eCollection 2018.

  PMID: 29304154 BACKGROUND

• Okesanya OJ, Ayeni RA, Amadin P, Ngwoke I, Amisu BO, Ukoaka BM, Ahmed MM, Oso TA, Musa SS, Lucero-Prisno DE. Advances in HIV Treatment and Vaccine Development: Emerging Therapies and Breakthrough Strategies for Long-Term Control. AIDS Res Treat. 2025 Jul 4;2025:6829446. doi: 10.1155/arat/6829446. eCollection 2025.

  PMID: 40655875 DERIVED

• Smith GHR, Henry WK, Podzamczer D, Masia MDM, Bettacchi CJ, Arasteh K, Jaeger H, Khuong-Josses MA, Montes-Ramirez ML, Stellbrink HJ, Yazdanpanah Y, Richmond GJ, Sutton KC, Zhang F, McCoig CC, St Clair MH, Vandermeulen K, Van Solingen-Ristea R, Smith KY, Margolis DA, Spreen WR. Efficacy, Safety, and Durability of Long-Acting Cabotegravir and Rilpivirine in Adults With Human Immunodeficiency Virus Type 1 Infection: 5-Year Results From the LATTE-2 Study. Open Forum Infect Dis. 2021 Aug 25;8(9):ofab439. doi: 10.1093/ofid/ofab439. eCollection 2021 Sep.

  PMID: 34557563 DERIVED

• Letendre SL, Mills A, Hagins D, Swindells S, Felizarta F, Devente J, Bettacchi C, Lou Y, Ford S, Sutton K, Shaik JS, Crauwels H, D'Amico R, Patel P. Pharmacokinetics and antiviral activity of cabotegravir and rilpivirine in cerebrospinal fluid following long-acting injectable administration in HIV-infected adults. J Antimicrob Chemother. 2020 Mar 1;75(3):648-655. doi: 10.1093/jac/dkz504.

  PMID: 31873746 DERIVED

• Murray M, Pulido F, Mills A, Ramgopal M, LeBlanc R, Jaeger H, Canon V, Dorey D, Griffith S, Mrus J, Spreen W, Margolis D. Patient-reported tolerability and acceptability of cabotegravir + rilpivirine long-acting injections for the treatment of HIV-1 infection: 96-week results from the randomized LATTE-2 study. HIV Res Clin Pract. 2019 Aug-Oct;20(4-5):111-122. doi: 10.1080/25787489.2019.1661696. Epub 2019 Sep 18.

  PMID: 31533539 DERIVED

• Margolis DA, Gonzalez-Garcia J, Stellbrink HJ, Eron JJ, Yazdanpanah Y, Podzamczer D, Lutz T, Angel JB, Richmond GJ, Clotet B, Gutierrez F, Sloan L, Clair MS, Murray M, Ford SL, Mrus J, Patel P, Crauwels H, Griffith SK, Sutton KC, Dorey D, Smith KY, Williams PE, Spreen WR. Long-acting intramuscular cabotegravir and rilpivirine in adults with HIV-1 infection (LATTE-2): 96-week results of a randomised, open-label, phase 2b, non-inferiority trial. Lancet. 2017 Sep 23;390(10101):1499-1510. doi: 10.1016/S0140-6736(17)31917-7. Epub 2017 Jul 24.

  PMID: 28750935 DERIVED

MeSH Terms

Conditions

Infections; Acquired Immunodeficiency Syndrome; HIV Infections

Interventions

Antiretroviral Therapy, Highly Active

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Drug Therapy, Combination; Drug Therapy; Therapeutics

Results Point of Contact

• Title: GSK Response Center
• Organization: ViiV Healthcare

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  ViiV Healthcare

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2014
• First Posted: April 22, 2014
• Study Start: April 28, 2014
• Primary Completion: August 13, 2015
• Study Completion: April 20, 2023
• Last Updated: June 12, 2024
• Results First Posted: August 31, 2020

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
• Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

Locations

US (15); ES (9); DE (9); CA (8); FR (9)