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Attachment Inhibitor Comparison in Heavily Treatment Experienced Patients

NCT ID: NCT02362503

Last Updated: 2025-08-22

Study Results

Results available

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Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

371 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-23

Study Completion Date

2026-09-30

Brief Summary

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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.

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A Study to Investigate the Use of VH3810109 With or Without Fostemsavir (FTR) to Reduce the Size and Activity of the Viral Reservoir in People Living With HIV

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Detailed Description

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Conditions

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HIV Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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A1: BMS-663068

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.

Group Type EXPERIMENTAL

BMS-663068

Intervention Type DRUG

BMS-663068

B1: Placebo + BMS-663068

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

Group Type ACTIVE_COMPARATOR

BMS-663068

Intervention Type DRUG

BMS-663068

Placebo

Intervention Type OTHER

Placebo

BMS-663068

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

Group Type EXPERIMENTAL

BMS-663068

Intervention Type DRUG

BMS-663068

Interventions

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BMS-663068

BMS-663068

Intervention Type DRUG

Placebo

Placebo

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ViiV Healthcare

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

ViiV Healthcare

Locations

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GSK Investigational Site

Los Angeles, California, United States

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Los Angeles, California, United States

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Los Angeles, California, United States

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Los Angeles, California, United States

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Palm Springs, California, United States

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San Francisco, California, United States

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Denver, Colorado, United States

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New Haven, Connecticut, United States

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

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

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Ft. Pierce, Florida, United States

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Orlando, Florida, United States

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West Palm Beach, Florida, United States

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Wilton Manors, Florida, United States

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Atlanta, Georgia, United States

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Atlanta, Georgia, United States

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Savannah, Georgia, United States

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Chicago, Illinois, United States

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Chicago, Illinois, United States

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Indianapolis, Indiana, United States

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Baltimore, Maryland, United States

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Baltimore, Maryland, United States

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Boston, Massachusetts, United States

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Southfield, Michigan, United States

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Hillsborough, New Jersey, United States

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Newark, New Jersey, United States

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Manhasset, New York, United States

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New York, New York, United States

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New York, New York, United States

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The Bronx, New York, United States

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Chapel Hill, North Carolina, United States

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Durham, North Carolina, United States

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Cincinnati, Ohio, United States

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Tulsa, Oklahoma, United States

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Philadelphia, Pennsylvania, United States

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Bellaire, Texas, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Buenos Aires, , Argentina

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Buenos Aires, , Argentina

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Buenos Aires, , Argentina

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Ciudad Autonoma de Buenos Aire, , Argentina

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Ciudad Autonoma de Bueno, , Argentina

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Córdoba, , Argentina

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Córdoba, , Argentina

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Rosario, , Argentina

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Darlinghurst, New South Wales, Australia

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Melbourne, Victoria, Australia

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Antwerp, , Belgium

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Brussels, , Belgium

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Belo Horizonte, , Brazil

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Campinas, , Brazil

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Curitiba, , Brazil

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Porto Alegre, , Brazil

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RibeirAo PretoSP, , Brazil

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Rio de Janeiro, , Brazil

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Salvador, , Brazil

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São Paulo, , Brazil

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São Paulo, , Brazil

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São Paulo, , Brazil

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Vancouver, British Columbia, Canada

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Vancouver, British Columbia, Canada

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Ottawa, Ontario, Canada

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Toronto, Ontario, Canada

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Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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Sainte-Foy, Quebec, Canada

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Santiago, , Chile

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Santiago, , Chile

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Santiago, , Chile

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Temuco, , Chile

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Bogotá, , Colombia

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Cali, , Colombia

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Bordeaux, , France

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Nantes, , France

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Berlin, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Dortmund, , Germany

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Frankfurt, , Germany

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Freiburg im Breisgau, , Germany

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München, , Germany

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Athens, , Greece

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Thessaloniki, , Greece

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Dublin, , Ireland

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Milan, , Italy

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Milan, , Italy

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Modena, , Italy

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Monza MB, , Italy

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Roma, , Italy

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Roma, , Italy

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Torino, , Italy

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Chihuahua City, , Mexico

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Distrito Federal, , Mexico

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Distrito Federal, , Mexico

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Guadalajara, , Mexico

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Mexico City, , Mexico

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México, , Mexico

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Utrecht, , Netherlands

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Iquitos, , Peru

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Lima, , Peru

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Lima, , Peru

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Lima, , Peru

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Lima, , Peru

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Szczecin, , Poland

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Warsaw, , Poland

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Lisbon, , Portugal

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Lisbon, , Portugal

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San Juan, , Puerto Rico

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Bucharest, , Romania

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Constanța, , Romania

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Irkutsk, , Russia

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Krasnodar, , Russia

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Auckland Park Johannesb, , South Africa

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Benoni, , South Africa

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Bloemfontein, , South Africa

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Cape Town, , South Africa

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Dundee, , South Africa

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Durban, , South Africa

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Observatory Cape Town, , South Africa

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Port Elizabeth, , South Africa

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Badalona, , Spain

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Barcelona, , Spain

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Madrid, , Spain

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Seville, , Spain

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Taipei, , Taiwan

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Bournemouth, , United Kingdom

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Leicester, , United Kingdom

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London, , United Kingdom

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Countries

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United States Argentina Australia Belgium Brazil Canada Chile Colombia France Germany Greece Ireland Italy Mexico Netherlands Peru Poland Portugal Puerto Rico Romania Russia South Africa Spain Taiwan United Kingdom

References

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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.

Reference Type BACKGROUND
PMID: 32212519 (View on PubMed)

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.

Reference Type DERIVED
PMID: 40990223 (View on PubMed)

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.

Reference Type DERIVED
PMID: 39233711 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38863717 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37751019 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35502922 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34180035 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33128903 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32027457 (View on PubMed)

Other Identifiers

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AI438-047

Identifier Type: OTHER

Identifier Source: secondary_id

2014-002111-41

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

205888

Identifier Type: -

Identifier Source: org_study_id

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