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| Name | Class |
|---|---|
| Gilead Sciences | INDUSTRY |
| Janssen Pharmaceuticals | INDUSTRY |
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The main purpose of this study is to compare two different types of HIV treatments, in terms of effectiveness and improvement of side effects, for patients who are diagnosed with a more advanced HIV infection. Patients with advanced HIV infections are otherwise known as 'late presenters'.
There are many effective treatments for HIV available; however, for late presenting patients the investigators do not know which type of treatment performs best. This is the first large study to compare treatments for patients in this situation, and the investigators hope that the results of this study will help doctors decide which treatments to use in the future.
The two different types of treatment the investigators are comparing both contain a mixture of drugs that work together to combat HIV:
The Boosted Protease Inhibitor combination (PI) which is a combination tablet containing: darunavir, cobicistat, emtricitabine and tenofovir alafenamide. It was approved for use in Europe under the brand name Symtuza®.
The Integrase Inhibitor combination (INI). Which is a combination tablet containing: bictegravir, emtricitabine and tenofovir alafenamide. This is a a newer combination which was approved for use in Europe in June 2018 under the brand name of Biktarvy®.
The main difference between the two treatments is how each one fights a HIV infection. They both stop a part of the virus from working (i.e. inhibit it), to prevent it from making copies of itself. The PI treatment contains drugs to stop the protease part of the virus, whereas the INI treatment contains drugs to stop the integrase part.
In recent studies, it appears that treatments containing integrase inhibitors may be better for late presenting patients. They have been shown to quickly bring down the amount of virus in the body, and the side effects may be more acceptable to late presenters.
To compare the two treatments, half of the participants on this study will be given the PI treatment, and the other half will be given the INI treatment.
The effectiveness of HIV antiretroviral therapy (ART) has consistently improved over the years. This is largely due to newer drugs having improved antiviral effectiveness and more tolerable side effect profiles; resulting in better viral suppression and improved treatment adherence. On the other hand, most recent clinical trials look at the effectiveness of ART in patients with less advanced disease. These patients usually suffer from less related diseases, drug-drug interactions, and other risks for treatment failure. Outside of these trials, the number of patients who present to clinic with a more developed advanced HIV infection, known as 'late presenters', remains high across Europe. Trials for these patients have tended to focus on the time of starting treatment and the management of infections.
Much less is known about which ART treatments perform best for these late presenting patients; particularly in terms of virus suppression, immune system recovery, side effects and improvement of AIDs related diseases. No specific drug combinations have been compared in appropriate clinical trials before, and the international guidelines for first line treatment judge all therapies as equal standard of care for these patients.
The investigators anticipate that Integrase inhibitor containing regimes may be better suited to patients with advanced disease, due to their beneficial side-effect profile and ability to rapidly decrease viral load levels. Therefore the investigators are conducting this clinical trial to compare an integrase inhibitor regime, against a protease inhibitor regime in patients with advanced HIV infection. The aim of the study is to demonstrate the non-inferiority of Biktarvy® against Symtuza®.
Patients will be recruited from sites across Europe, and randomized onto either arm of the study. After randomisation onto either treatment regime, patients will attend approximately 9 follow-up visits over the course of a year. During these visits, patients will be asked to complete two questionnaires, to assess their quality of life and HIV symptoms. They will also be asked to provide a number of blood samples. These samples are to ensure that the patient is not resistant to the study drug and that their disease is not worsening. Samples to test for study drug resistance will be shipped to a laboratory for analysis in the even that the patient experiences virological failure.
Biktarvy® will be supplied from Gilead and Symtuza® will be provided by Janssen Pharmaceuticals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biktarvy | Experimental | Bictegravir is an inhibitor of HIV-1 integrase that is being evaluated for the treatment of HIV-1 infection. Biktarvy® received marketing authorisation valid throughout the European Union (EU) in June 2018. Biktarvy is a combination of bictegravir, emtricitabine, and tenofovir (B/F/TAF). Method of administration: One combined B 50mg/F 200mg/TAF 25mg tablet taken orally once daily for up to 48 weeks without regard to food. |
|
| Symtuza | Experimental | Symtuza® is a boosted PI indicated for the treatment of HIV-1 infection. Symtuza® received marketing authorisation valid throughout the EU in September 2017. Symtuza is a combination of darunavir, cobicistat, emtricitabine and tenofovir alafenamide (D/C/F/TAF) Method of administration: One combined D 800mg/C 150mg/F 200mg/TAF 10mg tablet taken orally once daily for up to 48 weeks with the addition of food. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biktarvy | Drug | Integrase inhibitor used to treat HIV-1 infection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Failure | Composite outcome: treatment failure due to either virological or clinical reasons. Virological reasons can either be insufficient virological response or viral rebound. Clinical reasons can be death related to HIV/AIDS/opportunistic infection or severe bacterial infection, new or recurrent AIDS defining event, any serious non-AIDS defining event or clinically relevant adverse events of any grade or immune reconstitution inflammatory syndrome requiring treatment | Earliest at 12 weeks, latest 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients With HIV-RNA Viral Load <50 Copies/mL | at week 24, 36, 48 | Week 24, 36 and 48 |
| Time to Reach CD4 (Cluster of Differentiation 4) Count >200/µL | Through study completion, up to 48 weeks. |
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Inclusion Criteria:
The ability to understand and sign a written informed consent form (ICF) and must be willing to comply with all study requirements.
Male or non-pregnant, non-lactating females†.
Age ≥ 18 years.
Have documented, untreated HIV-1 infection with either:
AIDS with any CD4 cell count (AIDS-defining conditions are listed within Appendix 3).
Or
Severe bacterial infection (BI)‡ and must have a CD4 cell count < 200/μl within 28 days prior to study entry§.
Or
Any symptoms or no symptoms and must have a CD4 cell count < 100/μL within 28 days prior to study entry and must have an entry HIV viral load > 1000 copies/mL.
Or
Currently receiving treatment for OI**. i. Subjects with other serious OIs, including other AIDS-defining and AIDS-related OIs for which appropriate therapy other than ART exists are eligible, but Investigator approval must be obtained. ii. Current OI treatment can have been discontinued prior to start of ART.
Have an entry HIV viral load > 1000 copies/mL
Have the ability to take oral medications.
Females of childbearing potential and heterosexually active males must be willing to use a highly effective method of contraception and be willing to continue practising these birth control methods during the trial and for at least 30 days after the last dose of study medication. See Appendix 7 for further details.
Such methods include:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Georg Behrens | Hannover Medical School | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Tropical Medicine | Antwerp | Belgium | ||||
| CHU Saint-Pierre |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22748590 | Background | DeJesus E, Rockstroh JK, Henry K, Molina JM, Gathe J, Ramanathan S, Wei X, Yale K, Szwarcberg J, White K, Cheng AK, Kearney BP; GS-236-0103 Study Team. Co-formulated elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate versus ritonavir-boosted atazanavir plus co-formulated emtricitabine and tenofovir disoproxil fumarate for initial treatment of HIV-1 infection: a randomised, double-blind, phase 3, non-inferiority trial. Lancet. 2012 Jun 30;379(9835):2429-2438. doi: 10.1016/S0140-6736(12)60918-0. | |
| 23306000 |
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Number of Subjects Screened: 475
Number of Subjects Enrolled: 447
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| ID | Title | Description |
|---|---|---|
| FG000 | Biktarvy | Bictegravir is an inhibitor of HIV-1 integrase that is being evaluated for the treatment of HIV-1 infection. Biktarvy® received marketing authorisation valid throughout the European Union (EU) in June 2018. Biktarvy is a combination of bictegravir, emtricitabine, and tenofovir (B/F/TAF). Method of administration: One combined B 50mg/F 200mg/TAF 25mg tablet taken orally once daily for up to 48 weeks without regard to food. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 11, 2024 |
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| Symtuza |
| Drug |
Protease inhibitor used to treat HIV-1 infection |
|
| Proportion of Patients With CD4 Cell Count <200 and < 350μL at Week 4, 8, 12, 24, 36, 48 | 4, 8, 12, 24, 36, 48 weeks |
| CD4/CD8 (Cluster of Differentiation 8) Ratio | CD4/CD8 ratio at week 4, 8, 12, 24, 36, 48 | Week 4, 8, 12, 24, 36, 48 |
| Incidence of Immune Reconstitution Inflammatory Syndrome | Incidence of Immune Reconstitution Inflammatory Syndrome | Week 48 |
| Number of Participants With Hospitalisation or Relapse of Specific Opportunistic or Bacterial Infection | Start/Stop of hospitalization for any reason Start/Stop of opportunistic infections as listed within Appendix 3 (AIDS defining events according to https://www.cdc.gov/mmwr/preview/mmwrhtml/rr5710a2.htm) Start/Stop of severe BI, which consists of any of bacterial pneumonia, invasive bacterial infection (IBI) or any bacterial infectious disorder with grade 3 severity or requiring unscheduled hospital admission. An IBI is defined as the isolation of a bacterial organism from a normally sterile body site, or for bacterial nucleic acid to be detected at a normally sterile body site. Sterile body sites include blood, cerebrospinal fluid, pleural fluid, pericardial fluid, peritoneal fluid, joint fluid, bone aspirate, or a deep tissue abscess. | Week 48 |
| Number of Participants With Treatment-related Adverse Events as Assessed by Division of AIDS Adverse Event (AE) Grading Table Corrected Version 2.1-July 2017 | Week 48 |
| ART and OI/BI Treatment Changes and Dose Modifications Due to Toxicities and DDI With ART, and IRIS Through Week 48 | Antiretroviral therapy and opportunistic or bacterial infection treatment changes and dose modifications due to toxicities and drug-drug interaction with antiretroviral therapy, and Immune Reconstitution Inflammatory Syndrome | Week 48 |
| Health Care Resource Use, Including Number of Participants With Critical Care and Emergency Room Visits | Week 48 |
| QOL and Functional Status Outcomes, Including Overall Self-reported QOL and Functional Status Compared in the Two Groups at Week 48 | EQ-5D-3L (European Quality of life - 5 Dimensions - 3 Levels) and HIV Symptoms Index questionnaires will be completed by patients throughout the study to assess any change throughout their treatment Quality of life (EQ-5D-3L questionnaire) Scale is VAS Score which runs from 0 (worst health imaginable) to 100 (best health imaginable). We report the mean change from Baseline to W48. The HIV Symptom Index score is the sum of frequency ratings for the 20 selected symptoms; the score could range from 0 to 80 (80 being worst score). We report the mean change from Baseline to W48. | Week 48 |
| Discontinuation or Modification of Study Medication Due to Insufficient Virological Response or Resistance Mutation Development | Discontinuation or modification of the single tablet regimen due virological reasons defined as a) Insufficient virological response, either:
a. Rebound of HIV-1 RNA to >200 copies/mL after having achieved HIV-1 RNA <50 copies/mL b. Rebound of HIV RNA by >1 log 10 copies/mL from nadir value, for patients whose viral load has never been suppressed below 50 copies/mL | Week 48 |
| Duration of Hospitalisations | Duration of hospitalization for any reason | Week 48 |
| Brussels |
| Belgium |
| University Hospital Ghent | Ghent | Belgium |
| Hopital Europeen Marseille | Marseille | France |
| Groupe Hospitalier Sud Ile-de-France (Melun) | Melun | France |
| Hôpital Gui de Chauliac | Montpellier | France |
| CHU de Nantes | Nantes | France |
| Hopital Lariboisiere | Paris | France |
| Hopital Saint-Louis | Paris | France |
| Hôpital Saint Antoine | Paris | France |
| Pitié-Salpêtrière Hospital | Paris | France |
| Medizinische Klinik und Poliklinik Universitätsklinikum Bonn | Bonn | Germany |
| University Hospital Koln | Cologne | Germany |
| Goethe University Hospital Frankfurt | Frankfurt | Germany |
| University Hospital Geissen | Geißen | Germany |
| ICH Study Center Gmbh & Co. KG | Hamburg | Germany |
| Medizinische Hochschule Hannover | Hanover | Germany |
| University Hospital Klinikum rechts der Isar der TUM | Munich | Germany |
| Mater Misericordiae University Hospital | Dublin | Ireland |
| St Vincent's University Hospital | Dublin | Ireland |
| Luigi Sacco Hospital | Milan | Italy |
| Ospedale San Raffaele | Milan | Italy |
| ASST Santi Paolo | Milan | Italy |
| Clinica of Infectious Diseases | Modena | Italy |
| INMI Lazzaro Spallanzani, Rome | Rome | Italy |
| Hospital General Universatario Alicante | Alicante | Spain |
| Hospital Bellvitge | Barcelona | Spain |
| Hospital Clinic (Helios Building) | Barcelona | Spain |
| Hospital de la Santa Creu i Sant Pau | Barcelona | Spain |
| Hospital del Mar | Barcelona | Spain |
| Hospital Trias i Pujol | Barcelona | Spain |
| Hospital Universitari Vall d'Herbon | Barcelona | Spain |
| Hospital General Universitatrio de Elche | Elche | Spain |
| Hospital 12 Octubre | Madrid | Spain |
| Hospital de la Princesa | Madrid | Spain |
| Hospital Ramon y Cajal | Madrid | Spain |
| Hospital Universitatrio La Paz | Madrid | Spain |
| Hospital Virgen de la Victoria | Málaga | Spain |
| Royal Bournemouth Hospital | Bournemouth | United Kingdom |
| Southmead Hospital | Bristol | United Kingdom |
| Leeds Teaching Hospital | Leeds | United Kingdom |
| Barts Health | London | United Kingdom |
| Chelsea and Westminister | London | United Kingdom |
| Guy's Hospital | London | United Kingdom |
| Homerton University Hospital | London | United Kingdom |
| Imperial College Healthcare Trust | London | United Kingdom |
| Kings College London | London | United Kingdom |
| Mortimer Market Centre | London | United Kingdom |
| Royal Free Hospital | London | United Kingdom |
| St George's Hospital | London | United Kingdom |
| University Hospital Lewisham | London | United Kingdom |
| North Manchester General Hospital | Manchester | United Kingdom |
| Sheffield Teaching Hospital | Sheffield | United Kingdom |
| Background |
| Raffi F, Rachlis A, Stellbrink HJ, Hardy WD, Torti C, Orkin C, Bloch M, Podzamczer D, Pokrovsky V, Pulido F, Almond S, Margolis D, Brennan C, Min S; SPRING-2 Study Group. Once-daily dolutegravir versus raltegravir in antiretroviral-naive adults with HIV-1 infection: 48 week results from the randomised, double-blind, non-inferiority SPRING-2 study. Lancet. 2013 Mar 2;381(9868):735-43. doi: 10.1016/S0140-6736(12)61853-4. Epub 2013 Jan 8. |
| 24195548 | Background | Walmsley SL, Antela A, Clumeck N, Duiculescu D, Eberhard A, Gutierrez F, Hocqueloux L, Maggiolo F, Sandkovsky U, Granier C, Pappa K, Wynne B, Min S, Nichols G; SINGLE Investigators. Dolutegravir plus abacavir-lamivudine for the treatment of HIV-1 infection. N Engl J Med. 2013 Nov 7;369(19):1807-18. doi: 10.1056/NEJMoa1215541. |
| Background | Sax et al. Phase 3 Randomized, Controlled, Clinical Trial of Bictegravir Coformulated With FTC/TAF in a Fixed-Dose Combination vs Dolutegravir + FTC/TAF in Treatment-Naïve HIV-1-Positive Adults: Week 48 Results. 9th IAS Conference on HIV Science; Paris, France; July 23-26, 2017 |
| Background | Gallant et al. A phase 3 randomized controlled clinical trial of bictegravir in a fixed dose combination, B/F/TAF, vs ABC/DTG/3TC in treatment-naïve adults at week 48. 9th IAS Conference on HIV Science; Paris, France; July 23-26, 2017. MOAB0105LB |
| 23537210 | Background | Camoni L, Raimondo M, Regine V, Salfa MC, Suligoi B; regional representatives of the HIV Surveillance System. Late presenters among persons with a new HIV diagnosis in Italy, 2010-2011. BMC Public Health. 2013 Mar 27;13:281. doi: 10.1186/1471-2458-13-281. |
| 24047970 | Background | Montlahuc C, Guiguet M, Abgrall S, Daneluzzi V, de Salvador F, Launay O, Martinez V, Partisani M, Pradier C, Rouveix E, Valin N, Grabar S, Costagliola D; French Hospital Database ANRS CO4 cohort. Impact of late presentation on the risk of death among HIV-infected people in France (2003-2009). J Acquir Immune Defic Syndr. 2013 Oct 1;64(2):197-203. doi: 10.1097/QAI.0b013e31829cfbfa. |
| 20561080 | Background | Antinori A, Coenen T, Costagiola D, Dedes N, Ellefson M, Gatell J, Girardi E, Johnson M, Kirk O, Lundgren J, Mocroft A, D'Arminio Monforte A, Phillips A, Raben D, Rockstroh JK, Sabin C, Sonnerborg A, De Wolf F; European Late Presenter Consensus Working Group. Late presentation of HIV infection: a consensus definition. HIV Med. 2011 Jan;12(1):61-4. doi: 10.1111/j.1468-1293.2010.00857.x. |
| 27557878 | Background | Raffetti E, Postorino MC, Castelli F, Casari S, Castelnuovo F, Maggiolo F, Di Filippo E, D'Avino A, Gori A, Ladisa N, Di Pietro M, Sighinolfi L, Zacchi F, Torti C. The risk of late or advanced presentation of HIV infected patients is still high, associated factors evolve but impact on overall mortality is vanishing over calendar years: results from the Italian MASTER Cohort. BMC Public Health. 2016 Aug 25;16(1):878. doi: 10.1186/s12889-016-3477-z. |
| 22267463 | Background | Sobrino-Vegas P, Rodriguez-Urrego J, Berenguer J, Caro-Murillo AM, Blanco JR, Viciana P, Moreno S, Bernardino I, del Amo J; CoRIS. Educational gradient in HIV diagnosis delay, mortality, antiretroviral treatment initiation and response in a country with universal health care. Antivir Ther. 2012;17(1):1-8. doi: 10.3851/IMP1939. |
| 26624933 | Background | Late presenters working group in COHERE in EuroCoord; Mocroft A, Lundgren J, Antinori A, Monforte Ad, Brannstrom J, Bonnet F, Brockmeyer N, Casabona J, Castagna A, Costagliola D, De Wit S, Fatkenheuer G, Furrer H, Jadand C, Johnson A, Lazanas M, Leport C, Moreno S, Mussini C, Obel N, Post F, Reiss P, Sabin C, Skaletz-Rorowski A, Suarez-Loano I, Torti C, Warszawski J, Wittkop L, Zangerle R, Chene G, Raben D, Kirk O. Late presentation for HIV care across Europe: update from the Collaboration of Observational HIV Epidemiological Research Europe (COHERE) study, 2010 to 2013. Euro Surveill. 2015;20(47). doi: 10.2807/1560-7917.ES.2015.20.47.30070. |
| 22010915 | Background | Abdool Karim SS, Naidoo K, Grobler A, Padayatchi N, Baxter C, Gray AL, Gengiah T, Gengiah S, Naidoo A, Jithoo N, Nair G, El-Sadr WM, Friedland G, Abdool Karim Q. Integration of antiretroviral therapy with tuberculosis treatment. N Engl J Med. 2011 Oct 20;365(16):1492-501. doi: 10.1056/NEJMoa1014181. |
| 22010913 | Background | Blanc FX, Sok T, Laureillard D, Borand L, Rekacewicz C, Nerrienet E, Madec Y, Marcy O, Chan S, Prak N, Kim C, Lak KK, Hak C, Dim B, Sin CI, Sun S, Guillard B, Sar B, Vong S, Fernandez M, Fox L, Delfraissy JF, Goldfeld AE; CAMELIA (ANRS 1295-CIPRA KH001) Study Team. Earlier versus later start of antiretroviral therapy in HIV-infected adults with tuberculosis. N Engl J Med. 2011 Oct 20;365(16):1471-81. doi: 10.1056/NEJMoa1013911. |
| 19440326 | Background | Zolopa A, Andersen J, Powderly W, Sanchez A, Sanne I, Suckow C, Hogg E, Komarow L. Early antiretroviral therapy reduces AIDS progression/death in individuals with acute opportunistic infections: a multicenter randomized strategy trial. PLoS One. 2009;4(5):e5575. doi: 10.1371/journal.pone.0005575. Epub 2009 May 18. |
| 19005269 | Background | Mussini C, Manzardo C, Johnson M, Monforte Ad, Uberti-Foppa C, Antinori A, Gill MJ, Sighinolfi L, Borghi V, Lazzarin A, Miro JM, Sabin C; Late Presenter Investigators. Patients presenting with AIDS in the HAART era: a collaborative cohort analysis. AIDS. 2008 Nov 30;22(18):2461-9. doi: 10.1097/QAD.0b013e328314b5f1. |
| 29444582 | Background | Demarest J, Underwood M, St Clair M, Dorey D, Brown D, Zolopa A. Short Communication: Dolutegravir-Based Regimens Are Active in Integrase Strand Transfer Inhibitor-Naive Patients with Nucleoside Reverse Transcriptase Inhibitor Resistance. AIDS Res Hum Retroviruses. 2018 Apr;34(4):343-346. doi: 10.1089/AID.2017.0184. Epub 2018 Mar 22. |
| Background | Wijting I et al. Integrase Inhibitors are an Independent Risk Factor for IRIS: An ATHENA Cohort Study. Conference on Retroviruses and Opportunistic Infections. February 2017. Seattle, WA, USA. Abstract 731. |
| Background | Dutertre M et al. Initiation of ART Based on Integrase Inhibitors Increases the Risk of IRIS. Conference on Retroviruses and Opportunistic Infections. February 2017. Seattle, WA, USA. Abstract 732. |
| 29173177 | Background | Psichogiou M, Basoulis D, Tsikala-Vafea M, Vlachos S, Kapelios CJ, Daikos GL. Integrase Strand Transfer Inhibitors and the Emergence of Immune Reconstitution Inflammatory Syndrome (IRIS). Curr HIV Res. 2017;15(6):405-410. doi: 10.2174/1570162X15666171122155708. |
| 29278532 | Background | Hill AM, Mitchell N, Hughes S, Pozniak AL. Risks of cardiovascular or central nervous system adverse events and immune reconstitution inflammatory syndrome, for dolutegravir versus other antiretrovirals: meta-analysis of randomized trials. Curr Opin HIV AIDS. 2018 Mar;13(2):102-111. doi: 10.1097/COH.0000000000000445. |
| 28753637 | Background | Paredes R, Tzou PL, van Zyl G, Barrow G, Camacho R, Carmona S, Grant PM, Gupta RK, Hamers RL, Harrigan PR, Jordan MR, Kantor R, Katzenstein DA, Kuritzkes DR, Maldarelli F, Otelea D, Wallis CL, Schapiro JM, Shafer RW. Collaborative update of a rule-based expert system for HIV-1 genotypic resistance test interpretation. PLoS One. 2017 Jul 28;12(7):e0181357. doi: 10.1371/journal.pone.0181357. eCollection 2017. |
| Background | Levy et al. ANRS 146 - GeSIDA 7211 OPTIMAL phase III trial: maraviroc plus cART in advanced HIV-1-infected individuals. Journal Of The International Aids Society (Vol. 20, Pp. 6-7) |
| 27068399 | Background | Slama L, Landman R, Assoumou L, Benalycherif A, Samri A, Joly V, Pialoux G, Valin N, Cabie A, Duvivier C, Lambert-Niclot S, Marcelin AG, Peytavin G, Costagliola D, Girard PM; IMEA 040 DATA Study Group. Efficacy and safety of once-daily ritonavir-boosted atazanavir or darunavir in combination with a dual nucleos(t)ide analogue backbone in HIV-1-infected combined ART (cART)-naive patients with severe immunosuppression: a 48 week, non-comparative, randomized, multicentre trial (IMEA 040 DATA trial). J Antimicrob Chemother. 2016 Aug;71(8):2252-61. doi: 10.1093/jac/dkw103. Epub 2016 Apr 10. |
| 41344354 | Derived | Behrens GMN, Assoumou L, Liegeon G, Antinori A, Mican R, Genderini FG, Post FA, Rockstroh JK, Hamzah L, Domingo P, Curran A, Laguno M, Fletcher C, Moody J, Pozniak A; NEAT-ID Foundation; LAPTOP Study Team. Integrase versus protease inhibitor therapy in advanced HIV disease (LAPTOP): a multicountry, randomised, open-label, non-inferiority trial. Lancet Infect Dis. 2026 May;26(5):510-521. doi: 10.1016/S1473-3099(25)00681-4. Epub 2025 Dec 1. |
| FG001 | Symtuza | Symtuza® is a boosted PI indicated for the treatment of HIV-1 infection. Symtuza® received marketing authorisation valid throughout the EU in September 2017. Symtuza is a combination of darunavir, cobicistat, emtricitabine and tenofovir alafenamide (D/C/F/TAF) Method of administration: One combined D 800mg/C 150mg/F 200mg/TAF 10mg tablet taken orally once daily for up to 48 weeks with the addition of food. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Biktarvy | Bictegravir is an inhibitor of HIV-1 integrase that is being evaluated for the treatment of HIV-1 infection. Biktarvy® received marketing authorisation valid throughout the European Union (EU) in June 2018. Biktarvy is a combination of bictegravir, emtricitabine, and tenofovir (B/F/TAF). Method of administration: One combined B 50mg/F 200mg/TAF 25mg tablet taken orally once daily for up to 48 weeks without regard to food. |
| BG001 | Symtuza | Symtuza® is a boosted PI indicated for the treatment of HIV-1 infection. Symtuza® received marketing authorisation valid throughout the EU in September 2017. Symtuza is a combination of darunavir, cobicistat, emtricitabine and tenofovir alafenamide (D/C/F/TAF) Method of administration: One combined D 800mg/C 150mg/F 200mg/TAF 10mg tablet taken orally once daily for up to 48 weeks with the addition of food. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | >18 years | Median | Inter-Quartile Range | Years |
| ||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | White, Black, Other | Count of Participants | Participants | No |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Treatment Failure | Composite outcome: treatment failure due to either virological or clinical reasons. Virological reasons can either be insufficient virological response or viral rebound. Clinical reasons can be death related to HIV/AIDS/opportunistic infection or severe bacterial infection, new or recurrent AIDS defining event, any serious non-AIDS defining event or clinically relevant adverse events of any grade or immune reconstitution inflammatory syndrome requiring treatment | Each row represents a different analysis using different patient numbers, dependent on mITT or PP analysis | Posted | Count of Participants | Participants | Earliest at 12 weeks, latest 48 weeks |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Proportion of Patients With HIV-RNA Viral Load <50 Copies/mL | at week 24, 36, 48 | Posted | Count of Participants | Participants | Week 24, 36 and 48 |
|
| |||||||||||||||||||||||||||||||
| Secondary | Time to Reach CD4 (Cluster of Differentiation 4) Count >200/µL | Posted | Count of Participants | Participants | Through study completion, up to 48 weeks. |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Proportion of Patients With CD4 Cell Count <200 and < 350μL at Week 4, 8, 12, 24, 36, 48 | Number analysed differs due to:
| Posted | Count of Participants | Participants | 4, 8, 12, 24, 36, 48 weeks |
|
| |||||||||||||||||||||||||||||||
| Secondary | CD4/CD8 (Cluster of Differentiation 8) Ratio | CD4/CD8 ratio at week 4, 8, 12, 24, 36, 48 | Number analysed differs due to:
| Posted | Mean | Standard Error | Ratio | Week 4, 8, 12, 24, 36, 48 |
|
| |||||||||||||||||||||||||||||
| Secondary | Incidence of Immune Reconstitution Inflammatory Syndrome | Incidence of Immune Reconstitution Inflammatory Syndrome | Posted | Count of Participants | Participants | Week 48 |
|
| |||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Hospitalisation or Relapse of Specific Opportunistic or Bacterial Infection | Start/Stop of hospitalization for any reason Start/Stop of opportunistic infections as listed within Appendix 3 (AIDS defining events according to https://www.cdc.gov/mmwr/preview/mmwrhtml/rr5710a2.htm) Start/Stop of severe BI, which consists of any of bacterial pneumonia, invasive bacterial infection (IBI) or any bacterial infectious disorder with grade 3 severity or requiring unscheduled hospital admission. An IBI is defined as the isolation of a bacterial organism from a normally sterile body site, or for bacterial nucleic acid to be detected at a normally sterile body site. Sterile body sites include blood, cerebrospinal fluid, pleural fluid, pericardial fluid, peritoneal fluid, joint fluid, bone aspirate, or a deep tissue abscess. | Posted | Count of Participants | Participants | Week 48 |
| ||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment-related Adverse Events as Assessed by Division of AIDS Adverse Event (AE) Grading Table Corrected Version 2.1-July 2017 | Posted | Count of Participants | Participants | Week 48 |
|
| ||||||||||||||||||||||||||||||||
| Secondary | ART and OI/BI Treatment Changes and Dose Modifications Due to Toxicities and DDI With ART, and IRIS Through Week 48 | Antiretroviral therapy and opportunistic or bacterial infection treatment changes and dose modifications due to toxicities and drug-drug interaction with antiretroviral therapy, and Immune Reconstitution Inflammatory Syndrome | Posted | Count of Participants | Participants | Week 48 |
| ||||||||||||||||||||||||||||||||
| Secondary | Health Care Resource Use, Including Number of Participants With Critical Care and Emergency Room Visits | Posted | Count of Participants | Participants | Week 48 |
|
| ||||||||||||||||||||||||||||||||
| Secondary | QOL and Functional Status Outcomes, Including Overall Self-reported QOL and Functional Status Compared in the Two Groups at Week 48 | EQ-5D-3L (European Quality of life - 5 Dimensions - 3 Levels) and HIV Symptoms Index questionnaires will be completed by patients throughout the study to assess any change throughout their treatment Quality of life (EQ-5D-3L questionnaire) Scale is VAS Score which runs from 0 (worst health imaginable) to 100 (best health imaginable). We report the mean change from Baseline to W48. The HIV Symptom Index score is the sum of frequency ratings for the 20 selected symptoms; the score could range from 0 to 80 (80 being worst score). We report the mean change from Baseline to W48. | Posted | Mean | Standard Error | Questionnaire Score | Week 48 |
| |||||||||||||||||||||||||||||||
| Secondary | Discontinuation or Modification of Study Medication Due to Insufficient Virological Response or Resistance Mutation Development | Discontinuation or modification of the single tablet regimen due virological reasons defined as a) Insufficient virological response, either:
a. Rebound of HIV-1 RNA to >200 copies/mL after having achieved HIV-1 RNA <50 copies/mL b. Rebound of HIV RNA by >1 log 10 copies/mL from nadir value, for patients whose viral load has never been suppressed below 50 copies/mL | Posted | Count of Participants | Participants | Week 48 |
| ||||||||||||||||||||||||||||||||
| Secondary | Duration of Hospitalisations | Duration of hospitalization for any reason | Posted | Median | 95% Confidence Interval | Days | Week 48 |
|
|
The AE reporting period was from consent until the subject's final study visit (Week 52). In addition, any untoward event that may occur subsequent to the reporting period that the Investigator assessed as possibly, probably or definitely related to the study drug medication was reported as an AE.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Biktarvy | Bictegravir is an inhibitor of HIV-1 integrase that is being evaluated for the treatment of HIV-1 infection. Biktarvy® received marketing authorisation valid throughout the European Union (EU) in June 2018. Biktarvy is a combination of bictegravir, emtricitabine, and tenofovir (B/F/TAF). Method of administration: One combined B 50mg/F 200mg/TAF 25mg tablet taken orally once daily for up to 48 weeks without regard to food. | 9 | 220 | 52 | 220 | 111 | 220 |
| EG001 | Symtuza | Symtuza® is a boosted PI indicated for the treatment of HIV-1 infection. Symtuza® received marketing authorisation valid throughout the EU in September 2017. Symtuza is a combination of darunavir, cobicistat, emtricitabine and tenofovir alafenamide (D/C/F/TAF) Method of administration: One combined D 800mg/C 150mg/F 200mg/TAF 10mg tablet taken orally once daily for up to 48 weeks with the addition of food. | 3 | 222 | 54 | 222 | 120 | 222 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Acute appendicitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Acute renal failure | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Alcohol intoxication | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Altered state of consciousness | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Atypical mycobacterial pneumonia | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Balance disorder | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Systematic Assessment |
| |
| Behavioural disorder | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Bicytopenia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Bilateral pneumonia | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Breast ductal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cardiac ischemia | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cellulitis of toe | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Clostridium colitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Clostridium difficile sepsis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| CMV pneumonitis recurrent | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| CMV retinitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| CNS-IRIS | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cognitive impairment | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Community acquired pneumonia | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Condyloma excision | Surgical and medical procedures | MedDRA (Unspecified) | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cryptococcal meningitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cytomegalovirus infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cytomegalovirus infection reactivation | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cytomegalovirus viraemia | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Diffuse large B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Systematic Assessment |
| |
| Diplopia | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| DRESS syndrome | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Drug eruption NOS | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Drug-induced hepatotoxicity | Hepatobiliary disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Epiglottitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Fever | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Fever of unknown origin | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Gonococcal arthritis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Granulomatous disease | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Haemophilus pneumonia | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hepatopathy | Hepatobiliary disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| HIV encephalopathy | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| HIV with persistent generalized adenopathy | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hypercalcemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Immune reconstitution inflammatory syndrome | Immune system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Immune reconstitution syndrome | Immune system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Infection mycobacterium avium | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Intestinal pseudo-obstruction | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Intra-abdominal abscess | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| IRIS associated Kaposi's sarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Systematic Assessment |
| |
| Kaposi sarcoma inflammatory cytokine syndrome | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Kaposi's sarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Systematic Assessment |
| |
| Knee surgery NOS | Surgical and medical procedures | MedDRA (Unspecified) | Systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Lymphocytic meningitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Mastoiditis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Mediastinal lymphadenopathy | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Mediastinal mass | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Methemoglobinemia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Monkeypox | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Mycobacterial infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Mycobacterial infection NOS | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Mycobacterium avium complex immune restoration disease | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Mycobacterium avium complex infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Mycobacterium avium complex lymphadenitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Oesophageal candidiasis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Opportunistic infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pancolitis | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pneumocystis jirovecii infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pneumocystis jirovecii pneumonia | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pneumocystis pneumonia | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pneumocystosis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Polytrauma | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Posterior uveitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Progressive multifocal leukoencephalopathy | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pseudomonas infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pulmonary tuberculosis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Purulent pericarditis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pustular rash | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Reiter syndrome | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Renal calculi | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Renal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Respiratory infection | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Rhinovirus infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Rhodococcus equi infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| SARS-CoV-2 infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Septic arthritis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Skin rash | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Systematic Assessment |
| |
| Stereotactic needle biopsy of breast | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Stomach flu | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Swelling (r) testicle | Reproductive system and breast disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Thrombosis leg | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Toxoplasmosis recurrent | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Transcervical fracture, open | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Traumatic shock | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Tuberculosis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Upper gastrointestinal bleeding | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Viral pneumonia | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Visual acuity lost | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Respiratory infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Alcohol intoxication acute | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Drug Overdose | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Drug rash | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Fever | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Weight gain | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Oral Candiasis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
The open-label design may have influenced AE reporting, although objective outcomes were adjudicated The 48-week follow-up limits insight into long-term outcomes such as metabolic effects, weight gain, and virological durability.
Excluding patients with active tuberculosis or cryptococcal meningitis restricts applicability to high-risk subgroups.
The predominantly European cohort may not reflect PWAD in regions with higher burdens of opportunistic infections.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Project Manager | Research Organisation (KC) Ltd | +44 (0) 7508 439711 | LAPTOP@rokcservices.com |
| Aug 7, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000654125 | bictegravir, emtricitabine, tenofovir alafenamide, drug combination |
| C000632565 | symtuza |
Not provided
Not provided
Not provided
| Male |
|
| Spain |
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| France |
|
| Belgium |
|
| Italy |
|
| Germany |
|
| Ireland |
|
| Asian |
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| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| PP analysis |
|
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| Participants |
|
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| Participants |
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| Counts |
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| Participants |
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