Attachment Inhibitor Comparison in Heavily Treatment Experienced Patients

NCT02362503 | Active Not Recruiting Phase 3 Results

• 3 other identifiers: 205888AI438-0472014-002111-41
• Study Type: interventional
• Target: 371
• Locations: 25 countries
• Sites: 139

Brief Summary

The purpose of this study is to determine whether the BMS Attachment Inhibitor (BMS-663068) is effective in the treatment of heavily treatment experienced HIV-1 patients with multi-drug resistance.

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (1)

• Mean Change in Logarithm to the Base 10 (log10) HIV-1 Ribonucleic Acid (RNA) From Day 1 at Day 8-Randomized Cohort

  Plasma samples were collected for analysis of HIV-1 RNA. Mean change in log10 HIV-1 RNA from Day 1 was estimated using analysis of covariance (ANCOVA) with log10 HIV-1 RNA change from Day 1 at Day 8 as dependent variable, treatment (fostemsavir or placebo) as an independent variable, and Day 1 log10 HIV-1 RNA as a continuous covariate. Change from Day 1 was calculated as value at Day 8 minus value at Day 1. The analysis was performed on Intent-to-Treat Exposed (ITT-E) Population which comprised of all randomized participants who received at least one dose of study treatment. Missing HIV-1 RNA values at Day 8 were imputed using (a) Day 1 Observation Carried Forward (D1OCF) for participants without a value during blinded treatment (i.e, imputing a zero change from Day 1) or (b) Last Observation Carried Forward (LOCF) for participants with an early value during blinded treatment before the Day 8 analysis visit window.

  Day 1 and Day 8

Secondary Outcomes (13)

• Percentage of Participants With HIV-1 RNA Decreases From Day 1 That Exceed 0.5 log10 c/mL and 1.0 log10 c/mL at Day 8-Randomized Cohort

  Day 1 and Day 8

• Percentage of Participants With HIV-1 RNA <40 c/mL at Weeks 24, 48 and 96-Randomized Cohort

  At Weeks 24, 48 and 96

• Number of Participants With On-treatment Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Discontinuation (AELD)-Randomized Cohort

  Up to Week 96 analysis cut-off date

• Number of Participants With Toxicity Grade Increase in Clinical Chemistry Results to Grade 3-4 Relative to Baseline-Randomized Cohort

  Baseline and up to Week 96 analysis cut-off date

• Number of Participants With Toxicity Grade Increase in Hematology Results to Grade 3-4 Relative to Baseline-Randomized Cohort

  Baseline and up to Week 96 analysis cut-off date

Study Arms (3)

A1: BMS-663068

EXPERIMENTAL

Phase 1: BMS-663068 600 mg tablets orally twice daily for 8 days. Phase 2: BMS-663068 600 mg tablets orally twice daily for 48 weeks or longer.

Drug: BMS-663068

B1: Placebo + BMS-663068

ACTIVE COMPARATOR

Phase 1: Placebo twice daily for 8 days. Phase 2: BMS-663068 600 mg tablets orally twice daily for 48 weeks or longer.

Drug: BMS-663068; Other: Placebo

BMS-663068

EXPERIMENTAL

BMS-663068 600 mg tablets orally twice daily for 48 weeks or longer.

Drug: BMS-663068

Interventions

BMS-663068 DRUG

BMS-663068

A1: BMS-663068; B1: Placebo + BMS-663068; BMS-663068

Placebo OTHER

Placebo

B1: Placebo + BMS-663068

Eligibility Criteria

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

You may qualify if:

• Men and non-pregnant women with chronic HIV-1 infection
• Antiretroviral-experienced with documented historical or baseline resistance, intolerability, and/or contraindications to antiretrovirals in at least three classes
• Failing current antiretroviral regimen with a confirmed plasma HIV-1 RNA ≥ 400 c/mL (first value from Investigator, second from Screening labs)
• Must have ≤ 2 classes with at least 1 but no more than 2 fully-active antiretrovirals remaining which can be effectively combined to form a viable new regimen, based on current and/or documented historical resistance testing and tolerability and safety
• Able to receive ≥ 1 fully active approved antiretroviral as part of the OBT from Day 9 onwards in the Randomized Cohort
• Subjects without any remaining fully active approved antiretroviral may be enrolled in the Non-Randomized Cohort

You may not qualify if:

• Chronic untreated Hepatitis B virus (HBV) (however, patients with chronic treated HBV are eligible)
• HIV-2 infection
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 7 x ULN
• Alkaline Phosphatase \> 5 x ULN
• Bilirubin ≥ 1.5 x Upper limit of normal (ULN) (unless subject is currently on atazanavir and has predominantly unconjugated hyperbilirubinemia)

Sponsors & Collaborators

• ViiV Healthcare: lead

Study Sites (139)

GSK Investigational Site

Los Angeles, California, 90008, United States

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GSK Investigational Site

Los Angeles, California, 90027, United States

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GSK Investigational Site

Los Angeles, California, 90033, United States

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GSK Investigational Site

Los Angeles, California, 90069, United States

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GSK Investigational Site

Palm Springs, California, 92262, United States

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GSK Investigational Site

San Francisco, California, 94115, United States

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GSK Investigational Site

Denver, Colorado, 80262, United States

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GSK Investigational Site

New Haven, Connecticut, 06510, United States

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GSK Investigational Site

Washington D.C., District of Columbia, 20007, United States

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GSK Investigational Site

Washington D.C., District of Columbia, 20009, United States

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GSK Investigational Site

Ft. Pierce, Florida, 34982, United States

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GSK Investigational Site

Orlando, Florida, 32801, United States

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GSK Investigational Site

West Palm Beach, Florida, 33407, United States

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GSK Investigational Site

Wilton Manors, Florida, 33306, United States

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GSK Investigational Site

Atlanta, Georgia, 30308, United States

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GSK Investigational Site

Atlanta, Georgia, 30312, United States

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Savannah, Georgia, 31401, United States

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GSK Investigational Site

Chicago, Illinois, 60612, United States

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GSK Investigational Site

Chicago, Illinois, 60613, United States

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GSK Investigational Site

Indianapolis, Indiana, 46202, United States

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Baltimore, Maryland, 21201, United States

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GSK Investigational Site

Baltimore, Maryland, 21287, United States

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Boston, Massachusetts, 211, United States

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Southfield, Michigan, 48075, United States

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Hillsborough, New Jersey, 08844, United States

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GSK Investigational Site

Newark, New Jersey, 07102, United States

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Manhasset, New York, 11030, United States

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GSK Investigational Site

New York, New York, 10010, United States

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GSK Investigational Site

New York, New York, 10029, United States

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The Bronx, New York, 10467, United States

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Chapel Hill, North Carolina, 27599, United States

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Durham, North Carolina, 27710, United States

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Cincinnati, Ohio, 45267-0405, United States

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Tulsa, Oklahoma, 74135, United States

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Philadelphia, Pennsylvania, 19104, United States

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Bellaire, Texas, 77401, United States

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Dallas, Texas, 75235, United States

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GSK Investigational Site

Dallas, Texas, 75246, United States

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GSK Investigational Site

Houston, Texas, 77098, United States

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Buenos Aires, C1141ACG, Argentina

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GSK Investigational Site

Buenos Aires, C1202ABB, Argentina

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Buenos Aires, C1426ABP, Argentina

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Ciudad Autonoma de Buenos Aire, C1155ADP, Argentina

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Ciudad Autonoma de Bueno, C1405CKC, Argentina

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Córdoba, 5000, Argentina

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Córdoba, X5000JJS, Argentina

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Rosario, S2000PBJ, Argentina

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Darlinghurst, New South Wales, 2010, Australia

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Melbourne, Victoria, 3004, Australia

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Antwerp, 2000, Belgium

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Brussels, 1000, Belgium

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Belo Horizonte, 30130-100, Brazil

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Campinas, 13015-080, Brazil

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Curitiba, 80240-280, Brazil

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Porto Alegre, 90035-903, Brazil

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RibeirAo PretoSP, 14048-900, Brazil

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Rio de Janeiro, 21040-900, Brazil

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Salvador, 40110-060, Brazil

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São Paulo, 01416-901, Brazil

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GSK Investigational Site

São Paulo, 04040-002, Brazil

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GSK Investigational Site

São Paulo, 04121-000, Brazil

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Vancouver, British Columbia, V6H3N1, Canada

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Vancouver, British Columbia, V6Z 1Y8, Canada

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Ottawa, Ontario, K1H 8L6, Canada

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Toronto, Ontario, M5G 2N2, Canada

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Montreal, Quebec, H2L 4P9, Canada

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Montreal, Quebec, H2L 5B1, Canada

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Sainte-Foy, Quebec, G1V 4G5, Canada

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Santiago, 7500520, Chile

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Santiago, 8330074, Chile

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Santiago, 8360159, Chile

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Santiago, 8900088, Chile

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GSK Investigational Site

Temuco, 4781151, Chile

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GSK Investigational Site

Bogotá, 110111, Colombia

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GSK Investigational Site

Bogotá, 111311, Colombia

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GSK Investigational Site

Cali, 760032, Colombia

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Bordeaux, 33076, France

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Marseille, 13009, France

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GSK Investigational Site

Nantes, 44093, France

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GSK Investigational Site

Paris, 75004, France

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GSK Investigational Site

Paris, 75013, France

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GSK Investigational Site

Paris, 75018, France

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GSK Investigational Site

Paris, 75475, France

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GSK Investigational Site

Paris, 75571, France

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GSK Investigational Site

Paris, 75970, France

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Berlin, 10439, Germany

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Berlin, 12157, Germany

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GSK Investigational Site

Berlin, 13353, Germany

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Dortmund, 44137, Germany

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Frankfurt, 60590, Germany

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Freiburg im Breisgau, 79106, Germany

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GSK Investigational Site

München, 80336, Germany

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Athens, 16121, Greece

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Thessaloniki, 54636, Greece

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Dublin, Dublin 7, Ireland

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Milan, 20127, Italy

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Milan, 20157, Italy

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Modena, 41124, Italy

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Monza MB, 20900, Italy

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Roma, 00149, Italy

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Roma, 00168, Italy

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Torino, 10149, Italy

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Chihuahua City, 31000, Mexico

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Distrito Federal, 06470, Mexico

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Distrito Federal, 14000, Mexico

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GSK Investigational Site

Guadalajara, 44280, Mexico

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GSK Investigational Site

Mexico City, 6700, Mexico

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GSK Investigational Site

México, 03100, Mexico

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GSK Investigational Site

Utrecht, 3584 CX, Netherlands

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GSK Investigational Site

Iquitos, Iqui 01, Peru

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GSK Investigational Site

Lima, 11, Peru

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GSK Investigational Site

Lima, 14, Peru

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GSK Investigational Site

Lima, 1, Peru

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GSK Investigational Site

Lima, Lima 31, Peru

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GSK Investigational Site

Szczecin, 70-376, Poland

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Warsaw, 01-201, Poland

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GSK Investigational Site

Lisbon, 1069-166, Portugal

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GSK Investigational Site

Lisbon, 1649-035, Portugal

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GSK Investigational Site

San Juan, 909, Puerto Rico

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GSK Investigational Site

Bucharest, 021105, Romania

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GSK Investigational Site

Constanța, 021105, Romania

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GSK Investigational Site

Irkutsk, 664035, Russia

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GSK Investigational Site

Krasnodar, 350015, Russia

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GSK Investigational Site

Auckland Park Johannesb, 2092, South Africa

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GSK Investigational Site

Benoni, 1500, South Africa

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GSK Investigational Site

Bloemfontein, 9301, South Africa

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GSK Investigational Site

Cape Town, 7505, South Africa

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GSK Investigational Site

Dundee, 3000, South Africa

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GSK Investigational Site

Durban, 7925, South Africa

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GSK Investigational Site

Observatory Cape Town, 7925, South Africa

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GSK Investigational Site

Port Elizabeth, 6001, South Africa

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GSK Investigational Site

Badalona, 8916, Spain

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GSK Investigational Site

Barcelona, 08036, Spain

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GSK Investigational Site

Madrid, 28034, Spain

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GSK Investigational Site

Seville, 41014, Spain

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GSK Investigational Site

Taipei, 10002, Taiwan

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GSK Investigational Site

Bournemouth, BH7 7DW, United Kingdom

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GSK Investigational Site

Leicester, LE1 5WW, United Kingdom

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GSK Investigational Site

London, SW10 9NH, United Kingdom

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Related Publications (9)

• Kozal M, Aberg J, Pialoux G, Cahn P, Thompson M, Molina JM, Grinsztejn B, Diaz R, Castagna A, Kumar P, Latiff G, DeJesus E, Gummel M, Gartland M, Pierce A, Ackerman P, Llamoso C, Lataillade M; BRIGHTE Trial Team. Fostemsavir in Adults with Multidrug-Resistant HIV-1 Infection. N Engl J Med. 2020 Mar 26;382(13):1232-1243. doi: 10.1056/NEJMoa1902493.

  PMID: 32212519 BACKGROUND

• Benlarbi M, Richard J, Clemente T, Bourassa C, Tolbert WD, Prakash M, Chandravanshi M, Clark A, Pazgier M, Durand M, Castagna A, Finzi A. Fostemsavir Decreases the Levels of Anti-gp120 CD4-Induced Antibodies in Heavily Treatment-Experienced People With HIV. J Infect Dis. 2025 Sep 24:jiaf461. doi: 10.1093/infdis/jiaf461. Online ahead of print.

  PMID: 40990223 DERIVED

• Clark A, Prakash M, Chabria S, Pierce A, Castillo-Mancilla JR, Wang M, Du F, Tenorio AR. Inflammatory Biomarker Reduction With Fostemsavir Over 96 Weeks in Heavily Treatment-Experienced Adults With Multidrug-Resistant HIV-1 in the BRIGHTE Study. Open Forum Infect Dis. 2024 Aug 26;11(9):ofae469. doi: 10.1093/ofid/ofae469. eCollection 2024 Sep.

  PMID: 39233711 DERIVED

• Llibre JM, Aberg JA, Walmsley S, Velez J, Zala C, Crabtree Ramirez B, Shepherd B, Shah R, Clark A, Tenorio AR, Pierce A, Du F, Li B, Wang M, Chabria S, Warwick-Sanders M. Long-term safety and impact of immune recovery in heavily treatment-experienced adults receiving fostemsavir for up to 5 years in the phase 3 BRIGHTE study. Front Immunol. 2024 May 28;15:1394644. doi: 10.3389/fimmu.2024.1394644. eCollection 2024.

  PMID: 38863717 DERIVED

• Aberg JA, Shepherd B, Wang M, Madruga JV, Mendo Urbina F, Katlama C, Schrader S, Eron JJ, Kumar PN, Sprinz E, Gartland M, Chabria S, Clark A, Pierce A, Lataillade M, Tenorio AR. Week 240 Efficacy and Safety of Fostemsavir Plus Optimized Background Therapy in Heavily Treatment-Experienced Adults with HIV-1. Infect Dis Ther. 2023 Sep;12(9):2321-2335. doi: 10.1007/s40121-023-00870-6. Epub 2023 Sep 26.

  PMID: 37751019 DERIVED

• Gartland M, Cahn P, DeJesus E, Diaz RS, Grossberg R, Kozal M, Kumar P, Molina JM, Mendo Urbina F, Wang M, Du F, Chabria S, Clark A, Garside L, Krystal M, Mannino F, Pierce A, Ackerman P, Lataillade M. Week 96 Genotypic and Phenotypic Results of the Fostemsavir Phase 3 BRIGHTE Study in Heavily Treatment-Experienced Adults Living with Multidrug-Resistant HIV-1. Antimicrob Agents Chemother. 2022 Jun 21;66(6):e0175121. doi: 10.1128/aac.01751-21. Epub 2022 May 3.

  PMID: 35502922 DERIVED

• Anderson SJ, Murray M, Cella D, Grossberg R, Hagins D, Towner W, Wang M, Clark A, Pierce A, Llamoso C, Ackerman P, Lataillade M. Patient-Reported Outcomes in the Phase III BRIGHTE Trial of the HIV-1 Attachment Inhibitor Prodrug Fostemsavir in Heavily Treatment-Experienced Individuals. Patient. 2022 Jan;15(1):131-143. doi: 10.1007/s40271-021-00534-y. Epub 2021 Jun 28.

  PMID: 34180035 DERIVED

• Lataillade M, Lalezari JP, Kozal M, Aberg JA, Pialoux G, Cahn P, Thompson M, Molina JM, Moreno S, Grinsztejn B, Diaz RS, Castagna A, Kumar PN, Latiff GH, De Jesus E, Wang M, Chabria S, Gartland M, Pierce A, Ackerman P, Llamoso C. Safety and efficacy of the HIV-1 attachment inhibitor prodrug fostemsavir in heavily treatment-experienced individuals: week 96 results of the phase 3 BRIGHTE study. Lancet HIV. 2020 Nov;7(11):e740-e751. doi: 10.1016/S2352-3018(20)30240-X.

  PMID: 33128903 DERIVED

• Lagishetty C, Moore K, Ackerman P, Llamoso C, Magee M. Effects of Temsavir, Active Moiety of Antiretroviral Agent Fostemsavir, on QT Interval: Results From a Phase I Study and an Exposure-Response Analysis. Clin Transl Sci. 2020 Jul;13(4):769-776. doi: 10.1111/cts.12763. Epub 2020 Mar 19.

  PMID: 32027457 DERIVED

MeSH Terms

Conditions

HIV Infections

Interventions

fostemsavir

Condition Hierarchy (Ancestors)

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

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 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2015
• First Posted: February 13, 2015
• Study Start: February 23, 2015
• Primary Completion: August 18, 2016
• Study Completion (Estimated): September 30, 2026
• Last Updated: August 22, 2025
• Results First Posted: September 18, 2018

Record last verified: 2025-08

Locations

FR (9); DE (7); AU (2); NL (1); RU (2); ZA (8); ES (4); TW (1); BE (2); CO (3); IE (1); PL (2); GB (3); RO (2); CL (5); GR (2); IT (7); PT (2); AR (8); US (39); ME (6); PE (5); PR (1); BR (10); CA (7)