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New hope for Drug-Resistant HIV: fostemsavir shows promise in Late-Stage trial

NCT ID NCT02362503

Disease control Sponsor: ViiV Healthcare Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 21, 2026 · Updated 1 time

Summary

This study tests a new HIV medicine, fostemsavir, in people whose HIV has become resistant to many other drugs. About 371 adults with multi-drug resistant HIV took part. The goal was to see if fostemsavir could lower the amount of virus in their blood. This is a disease control study, meaning the treatment helps manage HIV but does not cure it.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

371 people

The number who actually took part.

Started

Feb 2015

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

HIV infectious disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HIV infections

Contacts and locations

Locations

  • GSK Investigational Site

    Los Angeles, California, 90008, United States

  • GSK Investigational Site

    Los Angeles, California, 90027, United States

  • GSK Investigational Site

    Los Angeles, California, 90033, United States

  • GSK Investigational Site

    Los Angeles, California, 90069, United States

  • GSK Investigational Site

    Palm Springs, California, 92262, United States

  • GSK Investigational Site

    San Francisco, California, 94115, United States

  • GSK Investigational Site

    Denver, Colorado, 80262, United States

  • GSK Investigational Site

    New Haven, Connecticut, 06510, United States

  • GSK Investigational Site

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

  • GSK Investigational Site

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

  • GSK Investigational Site

    Ft. Pierce, Florida, 34982, United States

  • GSK Investigational Site

    Orlando, Florida, 32801, United States

  • GSK Investigational Site

    West Palm Beach, Florida, 33407, United States

  • GSK Investigational Site

    Wilton Manors, Florida, 33306, United States

  • GSK Investigational Site

    Atlanta, Georgia, 30308, United States

  • GSK Investigational Site

    Atlanta, Georgia, 30312, United States

  • GSK Investigational Site

    Savannah, Georgia, 31401, United States

  • GSK Investigational Site

    Chicago, Illinois, 60612, United States

  • GSK Investigational Site

    Chicago, Illinois, 60613, United States

  • GSK Investigational Site

    Indianapolis, Indiana, 46202, United States

  • GSK Investigational Site

    Baltimore, Maryland, 21201, United States

  • GSK Investigational Site

    Baltimore, Maryland, 21287, United States

  • GSK Investigational Site

    Boston, Massachusetts, 211, United States

  • GSK Investigational Site

    Southfield, Michigan, 48075, United States

  • GSK Investigational Site

    Hillsborough, New Jersey, 08844, United States

  • GSK Investigational Site

    Newark, New Jersey, 07102, United States

  • GSK Investigational Site

    Manhasset, New York, 11030, United States

  • GSK Investigational Site

    New York, New York, 10010, United States

  • GSK Investigational Site

    New York, New York, 10029, United States

  • GSK Investigational Site

    The Bronx, New York, 10467, United States

  • GSK Investigational Site

    Chapel Hill, North Carolina, 27599, United States

  • GSK Investigational Site

    Durham, North Carolina, 27710, United States

  • GSK Investigational Site

    Cincinnati, Ohio, 45267-0405, United States

  • GSK Investigational Site

    Tulsa, Oklahoma, 74135, United States

  • GSK Investigational Site

    Philadelphia, Pennsylvania, 19104, United States

  • GSK Investigational Site

    Bellaire, Texas, 77401, United States

  • GSK Investigational Site

    Dallas, Texas, 75235, United States

  • GSK Investigational Site

    Dallas, Texas, 75246, United States

  • GSK Investigational Site

    Houston, Texas, 77098, United States

  • GSK Investigational Site

    Buenos Aires, C1141ACG, Argentina

  • GSK Investigational Site

    Buenos Aires, C1202ABB, Argentina

  • GSK Investigational Site

    Buenos Aires, C1426ABP, Argentina

  • GSK Investigational Site

    Ciudad Autonoma Buenos Aires, C1405CKC, Argentina

  • GSK Investigational Site

    Ciudad Autonoma de Buenos Aire, C1155ADP, Argentina

  • GSK Investigational Site

    Córdoba, 5000, Argentina

  • GSK Investigational Site

    Córdoba, X5000JJS, Argentina

  • GSK Investigational Site

    Rosario, S2000PBJ, Argentina

  • GSK Investigational Site

    Darlinghurst, New South Wales, 2010, Australia

  • GSK Investigational Site

    Melbourne, Victoria, 3004, Australia

  • GSK Investigational Site

    Antwerp, 2000, Belgium

  • GSK Investigational Site

    Brussels, 1000, Belgium

  • GSK Investigational Site

    Belo Horizonte, 30130-100, Brazil

  • GSK Investigational Site

    Campinas, 13015-080, Brazil

  • GSK Investigational Site

    Curitiba, 80240-280, Brazil

  • GSK Investigational Site

    Porto Alegre, 90035-903, Brazil

  • GSK Investigational Site

    RibeirAo PretoSP, 14048-900, Brazil

  • GSK Investigational Site

    Rio de Janeiro, 21040-900, Brazil

  • GSK Investigational Site

    Salvador, 40110-060, Brazil

  • GSK Investigational Site

    São Paulo, 01416-901, Brazil

  • GSK Investigational Site

    São Paulo, 04040-002, Brazil

  • GSK Investigational Site

    São Paulo, 04121-000, Brazil

  • GSK Investigational Site

    Vancouver, British Columbia, V6H3N1, Canada

  • GSK Investigational Site

    Vancouver, British Columbia, V6Z 1Y8, Canada

  • GSK Investigational Site

    Ottawa, Ontario, K1H 8L6, Canada

  • GSK Investigational Site

    Toronto, Ontario, M5G 2N2, Canada

  • GSK Investigational Site

    Montreal, Quebec, H2L 4P9, Canada

  • GSK Investigational Site

    Montreal, Quebec, H2L 5B1, Canada

  • GSK Investigational Site

    Sainte-Foy, Quebec, G1V 4G5, Canada

  • GSK Investigational Site

    Santiago, 7500520, Chile

  • GSK Investigational Site

    Santiago, 8330074, Chile

  • GSK Investigational Site

    Santiago, 8360159, Chile

  • GSK Investigational Site

    Santiago, 8900088, Chile

  • GSK Investigational Site

    Temuco, 4781151, Chile

  • GSK Investigational Site

    Bogotá, 110111, Colombia

  • GSK Investigational Site

    Bogotá, 111311, Colombia

  • GSK Investigational Site

    Cali, 760032, Colombia

  • GSK Investigational Site

    Bordeaux, 33076, France

  • GSK Investigational Site

    Marseille, 13009, France

  • GSK Investigational Site

    Nantes, 44093, France

  • GSK Investigational Site

    Paris, 75004, France

  • GSK Investigational Site

    Paris, 75013, France

  • GSK Investigational Site

    Paris, 75018, France

  • GSK Investigational Site

    Paris, 75475, France

  • GSK Investigational Site

    Paris, 75571, France

  • GSK Investigational Site

    Paris, 75970, France

  • GSK Investigational Site

    Berlin, 10439, Germany

  • GSK Investigational Site

    Berlin, 12157, Germany

  • GSK Investigational Site

    Berlin, 13353, Germany

  • GSK Investigational Site

    Dortmund, 44137, Germany

  • GSK Investigational Site

    Frankfurt, 60590, Germany

  • GSK Investigational Site

    Freiburg im Breisgau, 79106, Germany

  • GSK Investigational Site

    München, 80336, Germany

  • GSK Investigational Site

    Athens, 16121, Greece

  • GSK Investigational Site

    Thessaloniki, 54636, Greece

  • GSK Investigational Site

    Dublin, Dublin 7, Ireland

  • GSK Investigational Site

    Milan, 20127, Italy

  • GSK Investigational Site

    Milan, 20157, Italy

  • GSK Investigational Site

    Modena, 41124, Italy

  • GSK Investigational Site

    Monza MB, 20900, Italy

  • GSK Investigational Site

    Roma, 00149, Italy

  • GSK Investigational Site

    Roma, 00168, Italy

  • GSK Investigational Site

    Torino, 10149, Italy

  • GSK Investigational Site

    Chihuahua City, 31000, Mexico

  • GSK Investigational Site

    Distrito Federal, 06470, Mexico

  • GSK Investigational Site

    Distrito Federal, 14000, Mexico

  • GSK Investigational Site

    Guadajalara, 44280, Mexico

  • GSK Investigational Site

    Mexico City, 6700, Mexico

  • GSK Investigational Site

    México, 03100, Mexico

  • GSK Investigational Site

    Utrecht, 3584 CX, Netherlands

  • GSK Investigational Site

    Iquitos, Iqui 01, Peru

  • GSK Investigational Site

    Lima, 11, Peru

  • GSK Investigational Site

    Lima, 14, Peru

  • GSK Investigational Site

    Lima, 1, Peru

  • GSK Investigational Site

    Lima, Lima 31, Peru

  • GSK Investigational Site

    Szczecin, 70-376, Poland

  • GSK Investigational Site

    Warsaw, 01-201, Poland

  • GSK Investigational Site

    Lisbon, 1069-166, Portugal

  • GSK Investigational Site

    Lisbon, 1649-035, Portugal

  • GSK Investigational Site

    San Juan, 909, Puerto Rico

  • GSK Investigational Site

    Bucharest, 021105, Romania

  • GSK Investigational Site

    Constanța, 021105, Romania

  • GSK Investigational Site

    Irkutsk, 664035, Russia

  • GSK Investigational Site

    Krasnodar, 350015, Russia

  • GSK Investigational Site

    Auckland Park Johannesb, 2092, South Africa

  • GSK Investigational Site

    Benoni, 1500, South Africa

  • GSK Investigational Site

    Bloemfontein, 9301, South Africa

  • GSK Investigational Site

    Cape Town, 7505, South Africa

  • GSK Investigational Site

    Dundee, 3000, South Africa

  • GSK Investigational Site

    Durban, 7925, South Africa

  • GSK Investigational Site

    Observatory Cape Town, 7925, South Africa

  • GSK Investigational Site

    Port Elizabeth, 6001, South Africa

  • GSK Investigational Site

    Badalona, 8916, Spain

  • GSK Investigational Site

    Barcelona, 08036, Spain

  • GSK Investigational Site

    Madrid, 28034, Spain

  • GSK Investigational Site

    Seville, 41014, Spain

  • GSK Investigational Site

    Taipei, 10002, Taiwan

  • GSK Investigational Site

    Bournemouth, BH7 7DW, United Kingdom

  • GSK Investigational Site

    Leicester, LE1 5WW, United Kingdom

  • GSK Investigational Site

    London, SW10 9NH, United Kingdom

More trials for these conditions

Other studies related to the condition(s) this trial covers.