Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
634
Countries
4
Sites
12
HIV-1 Infection
To evaluate the efficacy of switching to oral weekly islatravir (ISL; MK-8591)/lenacapavir (LEN; GS-6207) tablet regimen versus continuing standard of care in virologically suppressed people with HIV (PWH) at Week 48.
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
- 27 Jan 2025 → ongoing
- Decision date (initial)
- 2025-01-09
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Gilead Sciences Inc
External identifiers
- EU CT number
- 2024-514047-28-00
- ClinicalTrials.gov
- NCT06630299
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Pharmacokinetic, Safety, Therapy
To evaluate the efficacy of switching to oral weekly islatravir (ISL; MK-8591)/lenacapavir (LEN; GS-6207) tablet regimen versus continuing standard of care in virologically suppressed people with HIV (PWH) at Week 48.
Secondary objectives 2
- To evaluate the efficacy of switching to oral weekly ISL/LEN in virologically suppressed people with HIV at Weeks 48 and 96
- To evaluate the safety and tolerability of oral weekly ISL/LEN
Conditions and MedDRA coding
HIV-1 Infection
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.1 | LLT | 10068341 | HIV-1 infection | 10021881 |
Regulatory references
- Scientific advice from competent authorities
- European Medicines Agency
- Plan to share IPD
- No
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Participants 18 years of age or older at screening and able to understand and give written informed consent.
- HIV-1 RNA < 50 copies/mL for ≥ 6 months before screening, as documented by: a) One HIV-1 RNA < 50 copies/mL immediately preceding the 24 week period prior to screening. b) Within 24 weeks prior to screening, if HIV-1 RNA results are available, all levels must be < 50 copies/mL. c) During the 6 to 12 months period prior to screening, transient detectable viremia ≥ 50 copies/mL is acceptable (“blip”), as long as it is not confirmed on 2 consecutive visits.
- Plasma HIV-1 RNA levels < 50 copies/mL at screening.
- Are receiving guideline-recommended standard of care treatment such as International Antiviral Society (IAS), Department of Health and Human Services (DHHS), European AIDS Clinical Society (EACS) consisting of 2 or 3 ARVs for ≥ 6 months prior to screening and willing to continue until Day 1. Participants in Treatment Group 2 must also be willing to continue their standard of care through at least Week 96. a) INSTI combined with 1 or 2 NRTIs (B/F/TAF, DTG/ABC/3TC, DTG+TXF/FTC, DTG/TDF/3TC, DTG/3TC, RAL+TXF/FTC, RAL+TDF/3TC, EVG/c/TXF/FTC), or b) Boosted PI combined with 2 NRTIs (D/C/F/TAF, boosted DRV+TXF/FTC, boosted DRV+TDF/3TC), or c) NNRTI combined with 2 NRTIs (DOR/TDF/3TC, DOR+TXF/FTC, DOR+TDF/3TC, RPV/TXF/FTC, RPV+TXF/FTC, RPV+TDF/3TC). Notes: RAL can be taken either once or twice daily; all other agents are to be taken once daily, including and single tablet regimen. TXF = TAF or TDF. Boosted PI taken once daily with cobicistat or ritonavir.
- Participants assigned female at birth and of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified methods of contraception as described in Appendix 11.5.
Exclusion criteria 18
- Prior virologic failure.
- History of or current clinical decompensated liver cirrhosis (eg, ascites, encephalopathy, or variceal bleeding).
- Active malignancy requiring acute systemic therapy.
- Abnormal electrocardiogram (ECG) at the screening visit that is clinically significant as determined by the investigator.
- Treatment < 3 months prior to screening or anticipated treatment during the study period with immunosuppressant therapies, hydroxyurea, foscarnet, radiation, or cytotoxic chemotherapeutic agents without approval from sponsor prior to randomization. Agents disallowed in Section 5.3 may not be considered for sponsor approval. (See Appendix 11.8.2 for United Kingdom [UK]-specific requirements for this criterion).
- Prior use of, or exposure to, ISL or LEN.
- Active, serious infections requiring parenteral therapy within 30 days before randomization.
- Active tuberculosis infection.
- Acute hepatitis within 30 days before randomization.
- HBV infection, as determined below at the screening visit: a) Positive HBV surface antigen OR b) Positive HBV core antibody and negative HBV surface antibody. Note: Participants found to be susceptible to HBV infection (eg, negative hepatitis B surface antibody at the screening visit, regardless of prior HBV vaccination history) should be recommended to receive HBV vaccination
- Active hepatitis C virus (HCV) coinfection, defined as detectable HCV RNA. Note: particpants with prior/inactive HCV infection (defined as undetectable HCV RNA) may be enrolled.
- Any of the following laboratory values at screening: 1. Creatinine clearance (CLcr) ≤ 30 mL/min according to the Cockcroft-Gault formula 2. Alanine aminotransferase (ALT) > 5 x upper limit of normal (ULN) 3. Direct bilirubin > 1.5 x ULN 4. Platelets < 50,000/μL 5. Hemoglobin < 8.0 g/dL
- Participation or planned participation in any other clinical study (including observational studies) without prior approval from the sponsor.
- Known hypersensitivity to any of the study drugs, their metabolites, or formulation excipients.
- 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 dosing requirements.
- Participants of childbearing potential (as defined in Appendix 11.5) who have a positive serum pregnancy test at screening or positive urine and serum pregnancy tests at Day 1 prior to study drug administration.
- Participants who plan to continue breastfeeding during the study.
- Requirement for ongoing therapy or use of any prohibited medications listed in Section 5.3 within 30 days prior to screening through the last dose of study drug.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The proportion of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48 as determined by the United States (US) Food and Drug Administration (FDA)-defined snapshot algorithm
Secondary endpoints 4
- Proportion of Participants with HIV-1 RNA ≥ 50 copies/mL at Week 96 as Determined by the US FDA-defined Snapshot Algorithm
- Proportion of Participants with HIV-1 RNA < 50 copies/mL at Week 48 and 96 as Determined by the US FDA-defined Snapshot Algorithm
- The change from baseline in CD4+ T-cell count at Weeks 48 and 96
- The proportion of participants discontinuing ISL/LEN due to treatment-emergent adverse events (AEs)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
PRD11488102 · Product
- Active substance
- Lenacapavir
- Other product name
- 2/300 ISLATRAVIR/LENACAPAVIR TABLET FDC
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 00 DF dosage form
- Max total dose
- 00 DF dosage form
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- GILEAD SCIENCES INC.
- Paediatric formulation
- No
- Orphan designation
- No
PRD11488101 · Product
- Active substance
- Lenacapavir
- Other product name
- 0.5/300 ISLATRAVIR/LENACAPAVIR TABLET FDC
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 00 DF dosage form
- Max total dose
- 00 DF dosage form
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- GILEAD SCIENCES INC.
- Paediatric formulation
- No
- Orphan designation
- No
Comparator 24
SCP265346 · ATC
- Active substance
- Rilpivirine
- Substance synonyms
- TMC278
- Route of administration
- ORAL
- Max daily dose
- 00 DF dosage form
- Max total dose
- 00 DF dosage form
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- J05AG05 — RILPIVIRINE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP32518772 · ATC
- Active substance
- Doravirine
- Substance synonyms
- MK-1439
- Route of administration
- ORAL USE
- Max daily dose
- 00 DF dosage form
- Max total dose
- 00 DF dosage form
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- J05AG06 — DORAVIRINE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP26619544 · ATC
- Active substance
- Emtricitabine
- Route of administration
- ORAL USE
- Max daily dose
- 00 DF dosage form
- Max total dose
- 00 DF dosage form
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- J05AR22 — EMTRICITABINE, TENOFOVIR ALAFENAMIDE, DARUNAVIR AND COBICISTAT
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP62267903 · ATC
- Active substance
- Emtricitabine
- Route of administration
- ORAL USE
- Max daily dose
- 00 DF dosage form
- Max total dose
- 00 DF dosage form
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- J05AR18 — EMTRICITABINE, TENOFOVIR ALAFENAMIDE, ELVITEGRAVIR AND COBICISTAT
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP36747772 · ATC
- Active substance
- Lamivudine
- Route of administration
- ORAL USE
- Max daily dose
- 00 DF dosage form
- Max total dose
- 00 DF dosage form
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- J05AR25 — LAMIVUDINE AND DOLUTEGRAVIR
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP219875 · ATC
- Active substance
- Emtricitabine
- Route of administration
- ORAL USE
- Max daily dose
- 00 DF dosage form
- Max total dose
- 00 DF dosage form
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- J05AR08 — EMTRICITABINE, TENOFOVIR DISOPROXIL AND RILPIVIRINE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP25147753 · ATC
- Active substance
- Raltegravir
- Substance synonyms
- MK-0518
- Route of administration
- ORAL USE
- Max daily dose
- 00 DF dosage form
- Max total dose
- 00 DF dosage form
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- J05AJ01 — RALTEGRAVIR
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP32489478 · ATC
- Active substance
- Lamivudine
- Route of administration
- ORAL USE
- Max daily dose
- 00 DF dosage form
- Max total dose
- 00 DF dosage form
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- J05AR24 — LAMIVUDINE, TENOFOVIR DISOPROXIL AND DORAVIRINE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP13237790 · ATC
- Active substance
- Emtricitabine
- Route of administration
- ORAL
- Max daily dose
- 00 DF dosage form
- Max total dose
- 00 DF dosage form
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- J05AR19 — EMTRICITABINE, TENOFOVIR ALAFENAMIDE AND RILPIVIRINE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP154508 · ATC
- Active substance
- Ritonavir
- Route of administration
- ORAL USE
- Max daily dose
- 00 DF dosage form
- Max total dose
- 00 DF dosage form
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- J05AE03 — RITONAVIR
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP12506478 · ATC
- Active substance
- Emtricitabine
- Route of administration
- ORAL USE
- Max daily dose
- 00 DF dosage form
- Max total dose
- 00 DF dosage form
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- J05AR03 — TENOFOVIR DISOPROXIL AND EMTRICITABINE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
—
SCP180063 · ATC
- Route of administration
- ORAL USE
- Max daily dose
- 00 DF dosage form
- Max total dose
- 00 DF dosage form
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- J05AE10 — DARUNAVIR
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP258704 · ATC
- Active substance
- Emtricitabine
- Route of administration
- ORAL USE
- Max daily dose
- 00 DF dosage form
- Max total dose
- 00 DF dosage form
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- J05AR09 — EMTRICITABINE, TENOFOVIR DISOPROXIL, ELVITEGRAVIR AND COBICISTAT
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP70716164 · ATC
- Active substance
- Abacavir
- Route of administration
- ORAL USE
- Max daily dose
- 00 DF dosage form
- Max total dose
- 00 DF dosage form
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- J05AR13 — LAMIVUDINE, ABACAVIR AND DOLUTEGRAVIR
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP170243 · ATC
- Active substance
- Cobicistat
- Substance synonyms
- GS-9350
- Route of administration
- ORAL USE
- Max daily dose
- 00 DF dosage form
- Max total dose
- 00 DF dosage form
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V03AX03 — COBICISTAT
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP19343691 · ATC
- Active substance
- Dolutegravir
- Substance synonyms
- GSK1349572
- Route of administration
- ORAL USE
- Max daily dose
- 00 DF dosage form
- Max total dose
- 00 DF dosage form
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- J05AJ03 — DOLUTEGRAVIR
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP31283932 · ATC
- Active substance
- Emtricitabine
- Route of administration
- ORAL USE
- Max daily dose
- 00 DF dosage form
- Max total dose
- 00 DF dosage form
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- J05AR20 — EMTRICITABINE, TENOFOVIR ALAFENAMIDE AND BICTEGRAVIR
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP12493294 · ATC
- Active substance
- Emtricitabine
- Route of administration
- ORAL USE
- Max daily dose
- 00 DF dosage form
- Max total dose
- 00 DF dosage form
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- J05AR17 — EMTRICITABINE AND TENOFOVIR ALAFENAMIDE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP141950893 · ATC
- Active substance
- Darunavir
- Route of administration
- ORAL USE
- Max daily dose
- 00 DF dosage form
- Max total dose
- 00 DF dosage form
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- J05AR14 — DARUNAVIR AND COBICISTAT
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP14406941 · ATC
- Active substance
- Abacavir Sulfate
- Substance synonyms
- Abacavir hemisulfate, ABACAVIR SULPHATE
- Route of administration
- ORAL USE
- Max daily dose
- 00 DF dosage form
- Max total dose
- 00 DF dosage form
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- J05AR02 — LAMIVUDINE AND ABACAVIR
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP17542550 · ATC
- Active substance
- Tenofovir Alafenamide
- Route of administration
- ORAL USE
- Max daily dose
- 00 DF dosage form
- Max total dose
- 00 DF dosage form
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- J05AF13 — TENOFOVIR ALAFENAMIDE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP184299 · ATC
- Active substance
- Emtricitabine
- Route of administration
- ORAL USE
- Max daily dose
- 00 DF dosage form
- Max total dose
- 00 DF dosage form
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- J05AF09 — EMTRICITABINE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP163943 · ATC
- Active substance
- Lamivudine
- Route of administration
- ORAL USE
- Max daily dose
- 00 DF dosage form
- Max total dose
- 00 DF dosage form
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- J05AF05 — LAMIVUDINE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Viread 123 mg film-coated tablets
PRD3567161 · Product
- Active substance
- Tenofovir Disoproxil
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 00 DF dosage form
- Max total dose
- 00 DF dosage form
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- J05AF07 — TENOFOVIR DISOPROXIL
- Marketing authorisation
- EU/1/01/200/004
- MA holder
- GILEAD SCIENCES IRELAND UNLIMITED COMPANY
- MA country
- Iceland
- 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 5
| Organisation | City, country | Duties |
|---|---|---|
| PPD Development LP ORG-100011560
|
Wilmington, United States | Other, Code 5 |
| Labcorp Central Laboratory Services LP ORG-100032236
|
Indianapolis, United States | Other |
| Signant Health LLC ORG-100040732
|
Blue Bell, United States | Interactive response technologies (IRT) |
| Yprime LLC ORG-100042888
|
Malvern, United States | Other |
| Scout Clinical ORG-100042228
|
Dallas, United States | Other |
Locations
4 EU/EEA countries · 12 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ongoing, recruitment ended | 22 | 4 |
| Netherlands | Ongoing, recruitment ended | 7 | 2 |
| Poland | Ongoing, recruitment ended | 9 | 2 |
| Spain | Ongoing, recruitment ended | 38 | 4 |
| Rest of world
Thailand, United States, South Africa, United Kingdom, Japan, Australia, Taiwan, Argentina, Switzerland, Puerto Rico
|
— | 558 | — |
Investigational sites
Medizinische Hochschule Hannover
Klinik für Rheumatologie und Immunologie, Carl-Neuberg-Strasse 1, Gross Buchholz, Hanover
MVZ Munchen Am Goetheplatz
MUC Research GmbH, Waltherstrasse 32, Ludwigsvorstadt-Isarvorstadt, Munich
Dr. Scholten & Schneeweiß GbR
N/A, Richard-Wagner-Strasse 13-17, 50674, Cologne
Mannheimer Onkologie Praxis
N/A, Q5 14-22, 68161 Mannheim, Mannheim
Amsterdam UMC Stichting
Infectious Diseases, Meibergdreef 9, 1105 AZ, Amsterdam
Leids Universitair Medisch Centrum (LUMC)
Infectious Diseases, Albinusdreef 2, 2333 ZA, Leiden
Wroclawskie Centrum Zdrowia Samodzielny Publiczny Zaklad Opieki Zdrowotnej
Ośrodek Profilaktyczno-Leczniczy Chorób Zakaźnych i Terapii Uzależnień, Ul Wszystkich Swietych 2, 50-136, Wroclaw
Samodzielny Publiczny Wojewodzki Szpital Zespolony W Szczecinie
Poradnia Nabytych Niedoborów Immunologicznych, Ul. Arkonska 4, 71-455, Szczecin
University Hospital Virgen Del Rocio S.L.
Internal medicine- Infectious Diseases, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital Universitario 12 De Octubre
Internal medicine- Infectious Diseases, Avenida De Cordoba Sn, 28041, Madrid
Hospital Universitario La Paz
Internal medicine- Infectious Diseases, Paseo De La Castellana 261, 28046, Madrid
Hospital Germans Trias I Pujol
Internal medicine- Infectious Diseases, Carretera Canyet 1a Planta, 08916, Badalona
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 | 2025-01-27 | 2025-01-28 | 2025-04-30 | ||
| Netherlands | 2025-03-03 | 2025-03-11 | 2025-04-23 | ||
| Poland | 2025-03-26 | 2025-03-27 | 2025-04-14 | ||
| Spain | 2025-01-29 | 2025-02-04 | 2025-04-15 |
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_2024-514047-28-00_Redacted | 2 |
| Recruitment arrangements (for publication) | K1_GS-US-563-5926_Addendum_to_Recruitment-Arrangements_DE_Public | 1.0 |
| Recruitment arrangements (for publication) | K1_GS-US-563-5926_Flyer_ES_Spanish_Public | n/a |
| Recruitment arrangements (for publication) | K1_GS-US-563-5926_Recruitment-Arrangements_DE_Public | 1.0 |
| Recruitment arrangements (for publication) | K1_GS-US-563-5926_Recruitment-Arrangements_ES_Public | n/a |
| Recruitment arrangements (for publication) | K1_GS-US-563-5926_Recruitment-Arrangements_NL_Public | N/A |
| Recruitment arrangements (for publication) | K1_GS-US-563-5926_Recruitment-Arrangments_PL_Polish_Public | N/A |
| Recruitment arrangements (for publication) | K1_GS-US-563-5926_Recruitment-Arrangments_PL_Polish_tc_NotPublic | N/A |
| Recruitment arrangements (for publication) | K1_GS-US-563-5926_Study-Flyer_PL_Polish_Public | n/a |
| Recruitment arrangements (for publication) | K2_GS-US-563-5926_Recruitment-Material-Study-Flyer_NL_Dutch_Public | n/a |
| Recruitment arrangements (for publication) | K2_GS-US-563-5926_Study-Flyer_DE_German_Public | n/a |
| Subject information and informed consent form (for publication) | L1_GS-US-563-5926_Main-ICF_DE_German_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_GS-US-563-5926_Main-ICF_ES_Spanish_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_GS-US-563-5926_Main-ICF_PL_Polish_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_GS-US-563-5926_Optional-Future-Research-ICF_DE_German_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_GS-US-563-5926_Preg-Con-ICF_ES_Spanish_Public | 3 |
| Subject information and informed consent form (for publication) | L1_GS-US-563-5926_Preg-Cont_ICF_DE_German_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_GS-US-563-5926_Pregnancy-ICF_PL_Polish_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_GS-US-563-5926_SIS-and-ICF-main_NL_Dutch_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_GS-US-563-5926_SIS-and-ICF-pregnancy-continuation_NL_Dutch_Public | 3.0 |
| Subject information and informed consent form (for publication) | L2_GS-US-563-5926_EQ-5D-5L_NL_Dutch_Public | 1.0 |
| Subject information and informed consent form (for publication) | L2_GS-US-563-5926_Gilead-2-item-preference-questionnaire_NL_Dutch_Public | 1.0 |
| Subject information and informed consent form (for publication) | L2_GS-US-563-5926_HAT-QoL-SF_NL_Dutch_Public | 1.0 |
| Subject information and informed consent form (for publication) | L2_GS-US-563-5926_HIV-DAQ-HIV-PP-R-HIV-PP-RC_NL_Dutch_Public | 1.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2 SmPC_Biktarvy | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2 SmPC_Delstrigo | 3 |
| Summary of Product Characteristics (SmPC) (for publication) | E2 SmPC_Descovy | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2 SmPC_Edurant | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2 SmPC_Eviplera | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2 SmPC_Genvoya | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2 SmPC_Truvada | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2 SmPC_tybost | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Emtriva | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Epivir | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Kivexa | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Rezolsta | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Viread | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Dovato | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Isentress | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Odefsey | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Pifeltro | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Prezista(darunavir) | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Ritonavir | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Ritonavir_V01 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Stribild | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Symtuza | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Tivicay | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Triumeq | 3 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2024-514047-28-00_ES_Redacted | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2024-514047-28-00_NL_Redacted | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2024-514047-28-00_PL_Redacted | 2 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-06 | Germany | Acceptable 2025-01-07
|
2025-01-09 |
| 2 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-02-18 | Germany | Acceptable 2025-04-07
|
2025-04-08 |
| 3 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-05-14 | Germany | Acceptable 2025-07-04
|
2025-07-07 |
| 4 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-07-23 | Germany | Acceptable 2025-09-08
|
2025-09-09 |
| 5 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-11-20 | Germany | Acceptable 2026-02-27
|
2026-02-27 |