Overview
Sponsor-declared trial summary
Phase
Phase II and Phase III (Integrated)
Status
Ended
Participants planned
675
Countries
5
Sites
27
HIV-1 Infection
Phase 2:To evaluate the efficacy of oral weekly GS-1720 coadministered with GS-4182 versus Biktarvy®(BVY; bictegravir/emtricitabine/tenofovir alafenamide, coformulated) in treatment-naive PWH at Week 24 Phase 3:To evaluate the efficacy of oral weekly GS-1720/GS-4182 fixed-dose combination (FDC) tablet regimen versus B…
Key facts
- Sponsor
- Gilead Sciences Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Virus Diseases [C02]
- Trial duration
- 3 Mar 2025 → 16 Mar 2026
- Decision date (initial)
- 2025-02-18
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Gilead Sciences Inc
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacogenomic, Therapy, Pharmacodynamic, Efficacy, Safety
Phase 2:To evaluate the efficacy of oral weekly GS-1720 coadministered with GS-4182 versus Biktarvy®(BVY; bictegravir/emtricitabine/tenofovir alafenamide, coformulated) in treatment-naive PWH at Week 24
Phase 3:To evaluate the efficacy of oral weekly GS-1720/GS-4182 fixed-dose combination (FDC) tablet regimen versus BVY in treatment-naive PWH at Week 48
Secondary objectives 5
- Phase 2: To evaluate the efficacy of oral weekly GS-1720 coadministered with GS-4182 versus BVY in treatment-naive PWH at Weeks 12, 24, and 48
- To evaluate the safety and tolerability of oral weekly GS-1720 coadministered with GS-4182 in treatment-naive PWH at Weeks 12, 24, and 48
- To evaluate the PK of oral weekly GS-1720 coadministered with GS-4182 in treatment-naive PWH
- Phase 3: To evaluate the efficacy of oral weekly GS-1720/GS-4182 FDC versus BVY in treatment-naive PWH at Weeks 48 and 96
- To evaluate the safety and tolerability of oral weekly GS-1720/GS-4182 FDC in treatment-naive PWH at Weeks 48 and 96
Conditions and MedDRA coding
HIV-1 Infection
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Participants must meet all of the following inclusion criteria to be eligible for participation in this study:
- Participants 18 years of age or older and able to understand and give written informed consent.
- Participants assigned male at birth and participants assigned female at birth and of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified methods of contraception.
- HIV-1 RNA ≥ 500 copies/mL at screening.
- Antiretroviral (ARV) treatment naive, except the use of oral pre-exposure prophylaxis or postexposure prophylaxis with emtricitabine/tenofovir disoproxil fumarate (coformulated; Truvada®) or emtricitabine/tenofovir alafenamide (coformulated; Descovy®), up to 1 month prior to screening.
Exclusion criteria 17
- Participants who meet any of the following exclusion criteria are not eligible to be enrolled in this study:Prior use of any long acting parenteral ARVs such as monoclonal antibodies, broadly neutralizing antibodies targeting HIV-1, LEN, injectable cabotegravir (including oral cabotegravir lead-in), and/or injectable rilpivirine.
- Documented resistance to the integrase strand-transfer inhibitor class, specifically, resistance-associated mutations E92G/Q, G118R, F121Y, Y143C/H/R, S147G, Q148H/K/R, N155H/S, or R263K in the integrase gene.
- Any of the following laboratory values at screening: CD4 cell count < 200 cells/mm3 at screening Estimated glomerular filtration rate < 60 mL/min according to the Modification of Diet in Renal Disease formula Hepatic transaminases (aspartate aminotransferase and alanine aminotransferase) > 1.5 × upper limit of normal (ULN) Direct bilirubin > 1.5 × ULN Platelets count < 50,000 cells/mm3 Hemoglobin < 8.0 g/dL
- Active tuberculosis infection.
- Active or occult hepatitis B virus (HBV) infection defined as (regardless of other HBV serologic results) below. Participants found to be susceptible to HBV infection should be recommended to receive an HBV vaccination. a) Hepatitis B surface antigen (HBsAg) positive OR b) Hepatitis B core antibody (HBcAb) positive and hepatitis B surface antibody (HBsAb) negative
- Active hepatitis C virus (HCV) defined as detectable HCV RNA. Note: participants with prior/inactive HCV infection (defined as undetectable HCV RNA) may enrol.
- Moderate/severe hepatic impairment or a history of or current clinical decompensated liver cirrhosis (eg, ascites, encephalopathy, or variceal bleeding).
- Current alcohol or substance use judged by the investigator to potentially interfere with participant study compliance.
- Have been treated within 6 months of study screening or expected to receive during the study immunosuppressant therapies or chemotherapeutic agents (eg, chronic [at least 4 weeks] systemic steroids, immunoglobulins, and other immune- or cytokine-based therapies).
- Participation in any other clinical study, including observational studies, without prior approval from the sponsor is prohibited while participating in this study.
- Positive serum pregnancy test at screening or positive pregnancy test at Day 1
- Participants with plans to breastfeed during the study period and within 60 days following the last dose of study drug.
- Serious illness requiring hospitalizations within 30 days prior to screening and during the screening period or active malignancy requiring acute systemic treatment.
- Known hypersensitivity to the study drug, its metabolites, or formulation excipient.
- Abnormal electrocardiogram (ECG) at the screening visit that is clinically significant as determined by the investigator.
- Requirement for ongoing therapy with or prior use of any prohibited medications.
- Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the participant unsuitable for the study or unable to comply with the dosing requirements, including medical history of psychotic disorder and/or use of antipsychotic medications prescribed for psychosis.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Phase 2: The proportion of participants with HIV-1 RNA < 50 copies/mL at Week 24 as determined by the United States (US) Food and Drug Administration (FDA)-defined snapshot algorithm
- Phase 3: The proportion of participants with HIV-1 RNA < 50 copies/mL at Week 48 as determined by the US FDA-defined snapshot algorithm
Secondary endpoints 7
- The proportion of participants with HIV-1 RNA < 50 copies/mL at Weeks 12 and 48 as determined by the US FDA-defined snapshot algorithm
- The change from baseline in log10 HIV-1 RNA and CD4 cell count at Weeks 12, 24, and 48
- The proportion of participants experiencing treatment-emergent adverse events (TEAEs), and treatment-emergent laboratory abnormalities through Weeks 12, 24, and 48
- PK parameters (Cmax, Tmax, Ctau, and AUCtau, as applicable) of GS-1720 and lenacapavir (LEN)
- Phase 3:The proportion of participants with HIV-1 RNA < 50 copies/mL at Week 96 as determined by the US FDA-defined snapshot algorithm
- The change from baseline in log10 HIV-1 RNA and CD4 cell count at Weeks 48 and 96
- The proportion of participants experiencing TEAEs, and treatment-emergent laboratory abnormalities through Weeks 48 and 96
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
PRD11631094 · Product
- Active substance
- GS-4182
- Other product name
- GS-4182 300mg tablets
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 600 mg milligram(s)
- Max treatment duration
- 48 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- GILEAD SCIENCES INC.
- Paediatric formulation
- No
- Orphan designation
- No
PRD11631093 · Product
- Active substance
- GS-1720
- Other product name
- GS-1720 325mg tablets
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 650 mg milligram(s)
- Max total dose
- 1300 mg milligram(s)
- Max treatment duration
- 48 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- GILEAD SCIENCES INC.
- Paediatric formulation
- No
- Orphan designation
- No
Comparator 1
Biktarvy 50 mg/200 mg/25 mg film-coated tablets
PRD6357588 · Product
- Active substance
- Emtricitabine
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 5099920099925 mg milligram(s)
- Max total dose
- 5099920099925 mg milligram(s)
- Max treatment duration
- 48 Week(s)
- Authorisation status
- Authorised
- ATC code
- J05AR20 — -
- Marketing authorisation
- EU/1/18/1289/001
- MA holder
- GILEAD SCIENCES IRELAND UNLIMITED COMPANY
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Gilead Sciences Inc.
- Sponsor organisation
- Gilead Sciences Inc.
- Address
- 333 Lakeside Drive
- City
- Foster City
- Postcode
- 94404-1147
- Country
- United States
Scientific contact point
- Organisation
- Gilead Sciences Inc.
- Contact name
- EU CT Support
Public contact point
- Organisation
- Gilead Sciences Inc.
- Contact name
- EU CT Support
Third parties 8
| Organisation | City, country | Duties |
|---|---|---|
| Seq-it GmbH & Co. KG ORG-100049739
|
Kaiserslautern, Germany | Other |
| Labcorp Drug Development Inc. ORG-100051241
|
Princeton, United States | Other |
| Monogram Biosciences Inc. ORG-100043273
|
South San Francisco, United States | Other |
| Signant Health Global LLC ORG-100040604
|
Blue Bell, United States | Other, Interactive response technologies (IRT) |
| Fisher Clinical Services Inc. ORG-100014726
|
Allentown, United States | Code 14 |
| PPD Development LP ORG-100011560
|
Wilmington, United States | On site monitoring, Code 12, Code 13, Code 2, Code 5 |
| Icon Clinical Research Limited ORG-100008322
|
Dublin 18, Ireland | Other |
| Medidata Solutions Inc. ORG-100016256
|
New York, United States | E-data capture |
Locations
5 EU/EEA countries · 27 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ended | 27 | 5 |
| Poland | Ended | 37 | 6 |
| Portugal | Ended | 38 | 5 |
| Romania | Ended | 36 | 5 |
| Spain | Ended | 48 | 6 |
| Rest of world
China, South Africa, Saudi Arabia, United Kingdom, Canada, United States, Chile, Puerto Rico, Turkey
|
— | 489 | — |
Investigational sites
Klinikum rechts der Isar der TU Muenchen AöR
Klinik und Poliklinik for lnnere Medizin II, Ismaninger Strasse 22, Au-Haidhausen, Munich
Medizinische Hochschule Hannover
Klinik für Rheumatologie und Immunologie, Carl-Neuberg-Strasse 1, Gross Buchholz, Hanover
ICH Study Center GmbH & Co. KG
n/a, Grindelallee 35, Rotherbaum, Hamburg
Universitaetsklinikum Essen AöR
Klinik für Dermatologie, Venerologie und Allergologie, HPSTD-Ambulanz, Hufelandstrasse 55, Holsterhausen, Essen
Universitaetsklinikum Bonn AöR
Medizinische Klinik und Poliklinik I, Immunologische Studienambulanz, Venusberg-Campus 1, Venusberg, Bonn
Uniwersytet Jagiellonski Collegium Medicum
Poradnia Nabytych Niedoborów Odporności, Ul. Jana I Jedrzeja Sniadeckich 10, 31-531, Cracow
Wojewodzki Szpital Obserwacyjno-Zakazny Im Tadeusza Browicza
Oddział Internistyczno-Zakaźny i Niedoborów Odpornościowych, Ul. Sw. Floriana 12, 85-030, Bydgoszcz
Samodzielny Publiczny Wojewodzki Szpital Zespolony W Szczecinie
Poradnia Nabytych Niedoborów Immunologicznych, Ul. Arkonska 4, 71-455, Szczecin
Punkt Zdrowia Hlebowicz Jakubowski Lekarze sp. p.
N/A, Ul. Jana Kochanowskiego 114, 80-405, Gdansk
Wojewodzki Szpital Zakazny W Warszawie SPZOZ
Poradnia Profilaktyczno-Lecznicza, Ul. Wolska 37, 01-201, Warsaw
Wojewodzki Specjalistyczny Szpital Im Dr Wl Bieganskiego
Oddział Kliniczny Chorób Zakaźnych i Hepatologii, odcinek nabytego niedoboru odporności, Ul. Gen. Karola Kniaziewicza 1/5, 91-347, Lodz
Unidade Local De Saude De Lisboa Ocidental E.P.E.
Department of Infectious Diseases - Hospital Egas Moniz, Rua Da Junqueira 126, 1349-019, Lisbon
Unidade Local De Saude De Santo Antonio E.P.E.
Infectious Diseases Unit, Largo Professor Abel Salazar, 4050-011, Porto
Unidade Local De Saude De Santa Maria E.P.E.
Infectious Diseases Department - Hospital Santa Maria, Avenida Professor Egas Moniz, 1649-035, Lisbon
Unidade Local De Saude De Amadora Sintra E.P.E.
Serviço de Infeciologia, Itinerario Complementar 19, 2720-276, Amadora
Unidade Local de Saude de Sao Joao E.P.E.
Serviço de Doenças Infeciosas - Hospital de São João, Alameda Professor Hernani Monteiro, 4200-319, Porto
Institutul National De Boli Infectioase Prof.Dr.Matei Bals
Infectious Diseases, Strada Dr. Calistrat Grozovici Nr. 1, 021105, Bucharest
Spitalul Clinic De Urgenta Prof Dr Agrippa Ionescu
Infectious Diseases, 149th Ic Bratianu Street, 077015, Balotesti
Spitalul Clinic De Boli Infectioase Constanta
Infectious Diseases, Bulevardul Ferdinand 100, 900709, Constanta
Clinical Hospital Of Infectious Diseases And Pneumophysiology Dr.Victor Babes Timisoara
Infectious Diseases, Strada Adam Gheorghe Nr. 13, 300310, Timisoara
Spitalul Clinic De Boli Infectioase Cluj-Napoca
Infectious Diseases, Strada Moldovan Iuliu 23, 400348, Cluj-Napoca
Hospital Clinic De Barcelona
Unidad de Enfermedades Infecciosas, Calle Villarroel 170, 08036, Barcelona
Hospital Clinico San Carlos
Servicio de Medicina Interna, Calle Del Profesor Martín Lagos S/n, 28040, Madrid
Hospital Arnau De Vilanova De Valencia
Servicio de Medicina Interna, Calle De San Clemente 12, 46015, Valencia
Hospital Universitario Virgen De La Victoria
Servicio de Medicina Interna, Calle Del Arroyo Teatinos S/N, 29010, Malaga
Hospital Alvaro Cunqueiro
Servicio de Medicina Interna, Estrada Clara Campoamor No 341, 36312, Vigo
Hospital Universitario Fundacion Jimenez Diaz
Unidad de Enfermedades Infecciosas, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Germany | 2025-03-03 | 2025-03-19 | 2025-06-06 | ||
| Poland | 2025-03-28 | 2025-04-01 | 2025-06-06 | ||
| Portugal | 2025-03-21 | 2025-04-09 | 2025-06-06 | ||
| Romania | 2025-03-28 | 2025-05-01 | 2025-06-06 | ||
| Spain | 2025-03-11 | 2025-03-13 | 2025-06-06 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 5 · Art. 38 CTR
Temporary halt TH-86431
- Halt date
- 2025-06-06
- Member states concerned
- Portugal
- Publication date
- 2025-06-12
- Reason
- Safety related (clinical or pre-clinical results)
- Explanation
- This temporary half of the trial is in relation to the USM submitted on 10 June 2026 (reference ID US-86044).
- Follow-up measures
- All participants must stop taking GS-1720 and/or GS-4182 as soon as possible and return to the site to complete an early study drug discontinuation (ESDD) according to the applicable protocol.
- Participants who discontinue GS-1720 and/or GS-4182 should remain in the study without receiving study drug and complete the necessary follow-up procedures according to the applicable protocol. If clinically appropriate (i.e., decline in CD4 and/or ALC), participants should be followed until their CD4 and/or ALC counts return to baseline.
- Participants in the comparator arm should be discontinued from the study after completing the necessary follow-up procedures according to the applicable protocol.
- In Study GS-US-695-6509 (WONDERS 1), participants who discontinue GS-1720 and GS-4182 should restart their prior antiretroviral regimen or initiate another appropriate standard of care regimen at the discretion of the investigator.
- In Study GS-US-695-7156 (WONDERS 2), participants who discontinue GS-1720 and GS-4182 should initiate another appropriate antiretroviral regimen at the discretion of the investigator, according to standard of care. - Benefit-risk balance changed
- Yes
- Treatment stopped
- Yes
Temporary halt TH-86430
- Halt date
- 2025-06-06
- Member states concerned
- Germany
- Publication date
- 2025-06-12
- Reason
- Safety related (clinical or pre-clinical results)
- Explanation
- This temporary half of the trial is in relation to the USM submitted on 10 June 2026 (reference ID US-86044).
- Follow-up measures
- All participants must stop taking GS-1720 and/or GS-4182 as soon as possible and return to the site to complete an early study drug discontinuation (ESDD) according to the applicable protocol.
- Participants who discontinue GS-1720 and/or GS-4182 should remain in the study without receiving study drug and complete the necessary follow-up procedures according to the applicable protocol. If clinically appropriate (i.e., decline in CD4 and/or ALC), participants should be followed until their CD4 and/or ALC counts return to baseline.
- Participants in the comparator arm should be discontinued from the study after completing the necessary follow-up procedures according to the applicable protocol.
- In Study GS-US-695-6509 (WONDERS 1), participants who discontinue GS-1720 and GS-4182 should restart their prior antiretroviral regimen or initiate another appropriate standard of care regimen at the discretion of the investigator.
- In Study GS-US-695-7156 (WONDERS 2), participants who discontinue GS-1720 and GS-4182 should initiate another appropriate antiretroviral regimen at the discretion of the investigator, according to standard of care. - Benefit-risk balance changed
- Yes
- Treatment stopped
- Yes
Temporary halt TH-86434
- Halt date
- 2025-06-06
- Member states concerned
- Poland
- Publication date
- 2025-06-12
- Reason
- Safety related (clinical or pre-clinical results)
- Explanation
- This temporary half of the trial is in relation to the USM submitted on 10 June 2026 (reference ID US-86044).
- Follow-up measures
- All participants must stop taking GS-1720 and/or GS-4182 as soon as possible and return to the site to complete an early study drug discontinuation (ESDD) according to the applicable protocol.
- Participants who discontinue GS-1720 and/or GS-4182 should remain in the study without receiving study drug and complete the necessary follow-up procedures according to the applicable protocol. If clinically appropriate (i.e., decline in CD4 and/or ALC), participants should be followed until their CD4 and/or ALC counts return to baseline.
- Participants in the comparator arm should be discontinued from the study after completing the necessary follow-up procedures according to the applicable protocol.
- In Study GS-US-695-6509 (WONDERS 1), participants who discontinue GS-1720 and GS-4182 should restart their prior antiretroviral regimen or initiate another appropriate standard of care regimen at the discretion of the investigator.
- In Study GS-US-695-7156 (WONDERS 2), participants who discontinue GS-1720 and GS-4182 should initiate another appropriate antiretroviral regimen at the discretion of the investigator, according to standard of care. - Benefit-risk balance changed
- Yes
- Treatment stopped
- Yes
Temporary halt TH-86433
- Halt date
- 2025-06-06
- Member states concerned
- Spain
- Publication date
- 2025-06-12
- Reason
- Safety related (clinical or pre-clinical results)
- Explanation
- This temporary half of the trial is in relation to the USM submitted on 10 June 2026 (reference ID US-86044).
- Follow-up measures
- All participants must stop taking GS-1720 and/or GS-4182 as soon as possible and return to the site to complete an early study drug discontinuation (ESDD) according to the applicable protocol.
- Participants who discontinue GS-1720 and/or GS-4182 should remain in the study without receiving study drug and complete the necessary follow-up procedures according to the applicable protocol. If clinically appropriate (i.e., decline in CD4 and/or ALC), participants should be followed until their CD4 and/or ALC counts return to baseline.
- Participants in the comparator arm should be discontinued from the study after completing the necessary follow-up procedures according to the applicable protocol.
- In Study GS-US-695-6509 (WONDERS 1), participants who discontinue GS-1720 and GS-4182 should restart their prior antiretroviral regimen or initiate another appropriate standard of care regimen at the discretion of the investigator.
- In Study GS-US-695-7156 (WONDERS 2), participants who discontinue GS-1720 and GS-4182 should initiate another appropriate antiretroviral regimen at the discretion of the investigator, according to standard of care. - Benefit-risk balance changed
- Yes
- Treatment stopped
- Yes
Temporary halt TH-86432
- Halt date
- 2025-06-06
- Member states concerned
- Romania
- Publication date
- 2025-06-12
- Reason
- Safety related (clinical or pre-clinical results)
- Explanation
- This temporary half of the trial is in relation to the USM submitted on 10 June 2026 (reference ID US-86044).
- Follow-up measures
- All participants must stop taking GS-1720 and/or GS-4182 as soon as possible and return to the site to complete an early study drug discontinuation (ESDD) according to the applicable protocol.
- Participants who discontinue GS-1720 and/or GS-4182 should remain in the study without receiving study drug and complete the necessary follow-up procedures according to the applicable protocol. If clinically appropriate (i.e., decline in CD4 and/or ALC), participants should be followed until their CD4 and/or ALC counts return to baseline.
- Participants in the comparator arm should be discontinued from the study after completing the necessary follow-up procedures according to the applicable protocol.
- In Study GS-US-695-6509 (WONDERS 1), participants who discontinue GS-1720 and GS-4182 should restart their prior antiretroviral regimen or initiate another appropriate standard of care regimen at the discretion of the investigator.
- In Study GS-US-695-7156 (WONDERS 2), participants who discontinue GS-1720 and GS-4182 should initiate another appropriate antiretroviral regimen at the discretion of the investigator, according to standard of care. - Benefit-risk balance changed
- Yes
- Treatment stopped
- Yes
Urgent safety measures 1 · Art. 54 CTR
Urgent safety measure US-86044
- Event date
- 2025-06-06
- Submission date
- 2025-06-10
- In response to
- UNEXPECTED
- Member states affected
- Germany, Portugal, Romania, Spain, Poland
- Event description
- On June 6, 2025 afternoon PST, the FDA placed a full clinical hold on all clinical trials in which participants are receiving GS-1720 and/or GS-4182.This hold is subsequent to the notification of an unexpected event (UE) reported on 06 June 2025 (ex-US countries) regarding a safety signal of CD4+ T-lymphocyte (CD4)/absolute lymphocyte count (ALC) declines for patients receiving GS-1720+GS-4182.
- Measures taken
- With the safety and wellbeing of our study participants being paramount, Gilead has made the decision to stop all GS-1720 and/or GS-4182 dosing in any study participant and screening and enrollment of new participants are not permitted. As a result of this decision, the following
actions are warranted:
1. All participants must stop taking GS-1720 and/or GS-4182 as soon as possible and return to the site to complete an early study drug discontinuation (ESDD) according to the applicable protocol.
2. Participants who discontinue GS-1720 and/or GS-4182 should remain in the study without receiving study drug and complete the necessary follow-up procedures according to the applicable protocol. If clinically appropriate (i.e., decline in CD4 and/or ALC), participants should be followed until their CD4 and/or ALC counts return to baseline.
3. Participants in the comparator arm should be discontinued from the study after completing the necessary follow-up procedures according to the applicable protocol.
4.In Study GS-US-695-6509 (WONDERS 1), participants who discontinue GS-1720 and GS-4182 should restart their prior antiretroviral regimen or initiate another appropriate standard of care regimen at the discretion of the investigator.
Unexpected events 1 · Art. 53 CTR
Note: SUSARs are reported via EudraVigilance, not CTIS — events shown here are CTIS-public notifications only.
Unexpected event UE-85679
- Event date
- 2025-05-07
- Date aware
- 2025-05-22
- Submission date
- 2025-06-06
- Member states affected
- Germany, Portugal, Romania, Spain, Poland
- Clinical procedures
- Administration of study drug
- Event description
- statistically significant difference in mean CD4+ T-lymphocyte (CD4) count change from baseline between the GS-1720+GS-4182 and the Biktarvy (BVY) treatment groups and a statistically
significant decline in mean CD4 counts from baseline in the GS-1720+GS-4182 group
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 51 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2024-512505-66-00_Redacted | 1.2 |
| Protocol (for publication) | D4_Patient facing documents_HIVTSQs | 1 |
| Protocol (for publication) | D4_Patient facing documents_HIVTSQs_DE | 1 |
| Protocol (for publication) | D4_Patient facing documents_HIVTSQs_ES | 1 |
| Protocol (for publication) | D4_Patient facing documents_HIVTSQs_PL | 1 |
| Protocol (for publication) | D4_Patient facing documents_HIVTSQs_PT | 1 |
| Protocol (for publication) | D4_Patient facing documents_HIVTSQs_RO | 1 |
| Protocol (for publication) | D4_Patient facing documents_Modified Berger HIV Stigma | 1 |
| Protocol (for publication) | D4_Patient facing documents_Modified Berger HIV Stigma Scale_DE | 1 |
| Protocol (for publication) | D4_Patient facing documents_Modified Berger HIV Stigma Scale_ES | 1 |
| Protocol (for publication) | D4_Patient facing documents_Modified Berger HIV Stigma Scale_PL | 1 |
| Protocol (for publication) | D4_Patient facing documents_Modified Berger HIV Stigma Scale_PT | 1 |
| Protocol (for publication) | D4_Patient facing documents_Modified Berger HIV Stigma Scale_RO | 1 |
| Recruitment arrangements (for publication) | K1_GS-US-695-7156_Addendum_to_Recruitment_Informed_Consent_Procedure_DE_Public | n/a |
| Recruitment arrangements (for publication) | K1_GS-US-695-7156_Recruitment-Arrangement_DE_Public | n/a |
| Recruitment arrangements (for publication) | K1_GS-US-695-7156_Recruitment-Arrangements_ES_Public | n/a |
| Recruitment arrangements (for publication) | K1_GS-US-695-7156_Recruitment-Arrangements_PT_Public | N/A |
| Recruitment arrangements (for publication) | K1_GS-US-695-7156_Recruitment-Arrangements_ROU_Public | 1 |
| Recruitment arrangements (for publication) | K1_GS-US-695-7156_Recruitment-Informed-Consent-Procedure_PL_Polish_Public | n/a |
| Subject information and informed consent form (for publication) | L_GS-US-695-7156_Main_ICF_ROU_English_Public | 2.0 |
| Subject information and informed consent form (for publication) | L_GS-US-695-7156_Main_ICF_ROU_Romanian_Public | 2.0 |
| Subject information and informed consent form (for publication) | L_GS-US-695-7156_Optional_Prescreening_Rapid_HIV_Test_ICF_ROU_English_Public | 2.0 |
| Subject information and informed consent form (for publication) | L_GS-US-695-7156_Optional_Prescreening_Rapid_HIV_Test_ICF_ROU_Romanian_Public | 2.0 |
| Subject information and informed consent form (for publication) | L_GS-US-695-7156_Optional_XX_Phase_2_ICF_ROU_English_Public | 2.0 |
| Subject information and informed consent form (for publication) | L_GS-US-695-7156_Optional_XX_Phase_2_ICF_ROU_Romanian_Public | 2.0 |
| Subject information and informed consent form (for publication) | L_GS-US-695-7156_Partner_Pregnancy_ICF_ROU_English_Public | 2.0 |
| Subject information and informed consent form (for publication) | L_GS-US-695-7156_Partner_Pregnancy_ICF_ROU_Romanian_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_GS-US-695-7156_Addendum-Extended-Follow- up-ICF_PL_Polish_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_GS-US-695-7156_Addendum-Extended-Follow-up-ICF_PT_Portuguese_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_GS-US-695-7156_Future Research ICF_DE_German_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_GS-US-695-7156_ICF_Main_PL_Polish_Public | 2 |
| Subject information and informed consent form (for publication) | L1_GS-US-695-7156_ICF_optional-xx_PL_Polish_Public | 2 |
| Subject information and informed consent form (for publication) | L1_GS-US-695-7156_ICF_pregnant-partner_PL_Polish_Public | 2 |
| Subject information and informed consent form (for publication) | L1_GS-US-695-7156_ICF-prescreening_PL_Polish_Public | 2 |
| Subject information and informed consent form (for publication) | L1_GS-US-695-7156_Main ICF_DE_German_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_GS-US-695-7156_Main_ICF_ES_Spanish_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_GS-US-695-7156_Main-ICF_PT_Portuguese_clean_Public | 2.1 |
| Subject information and informed consent form (for publication) | L1_GS-US-695-7156_Optional-Presecreen-HIV-Test-ICF_PT_Portuguese_Public | 2.1 |
| Subject information and informed consent form (for publication) | L1_GS-US-695-7156_Optional-XX ICF_DE_German_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_GS-US-695-7156_Optional-XX-ICF_PT_Portuguese_Public | 2.1 |
| Subject information and informed consent form (for publication) | L1_GS-US-695-7156_Pregnancy-Baby-FUP-ICF_PT_Portuguese_Public | 2.1 |
| Subject information and informed consent form (for publication) | L1_GS-US-695-7156_Pregnant-Participant-and-Partner ICF_DE_German_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_GS-US-695-7156_prescreening-hiv-test_ICF_DE_German_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_GS-US-695-7156_XXX ICF_DE_German_Public | 2.1 |
| Subject information and informed consent form (for publication) | L2_GS-US-695-7156_Pregnant_Partner_ICF_ES_Spanish_Public | 2.0 |
| Subject information and informed consent form (for publication) | L3_GS-US-695-7156_Optional_Pre-screening_ICF_ES_Spanish_Public | 2.0 |
| Subject information and informed consent form (for publication) | L4_GS-US-695-7156_Optional_XX_ICF_ES_Spanish_Public | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2024-512505-66-00_ES_redacted | Amd 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2024-512505-66-00_PL_redacted | Amd 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2024-512505-66-00_PT_redacted | Amd 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2024-512505-66-00_RO_redacted | Amd 1 |
Application history
7 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-16 | Germany | Acceptable 2025-02-07
|
2025-02-12 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-02-27 | Acceptable 2025-02-07
|
2025-02-27 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-03-21 | Germany | Acceptable | 2025-04-01 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-04-02 | Germany | Acceptable | 2025-04-02 |
| 5 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-04-25 | Acceptable | 2025-05-19 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-09-17 | Acceptable | 2025-10-06 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-09-17 | Acceptable | 2025-10-29 |