Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE3
Total Enrollment
447 participants
Study Classification
INTERVENTIONAL
Study Start Date
2019-03-05
Study Completion Date
2024-06-17
Brief Summary
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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.
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.
Detailed Description
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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.
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.
Conditions
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HIV/AIDS
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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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.
Group Type
EXPERIMENTAL
Biktarvy
Intervention Type
DRUG
Integrase inhibitor used to treat HIV-1 infection
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.
Group Type
EXPERIMENTAL
Symtuza
Intervention Type
DRUG
Protease inhibitor used to treat HIV-1 infection
Interventions
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Biktarvy
Integrase inhibitor used to treat HIV-1 infection
Intervention Type
DRUG
Symtuza
Protease inhibitor used to treat HIV-1 infection
Intervention Type
DRUG
Eligibility Criteria
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Inclusion Criteria
1. The ability to understand and sign a written informed consent form (ICF) and must be willing to comply with all study requirements.
2. Male or non-pregnant, non-lactating females†.
3. Age ≥ 18 years.
4. Have documented, untreated HIV-1 infection with either:
1. AIDS with any CD4 cell count (AIDS-defining conditions are listed within Appendix 3).
Or
2. Severe bacterial infection (BI)‡ and must have a CD4 cell count \< 200/μl within 28 days prior to study entry§.
Or
3. 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
4. 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.
5. Have an entry HIV viral load \> 1000 copies/mL
6. Have the ability to take oral medications.
7. 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:
* True abstinence from penile-vaginal intercourse, when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods), and withdrawal are not acceptable methods of contraception).
* Non-hormonal Intrauterine device or non-hormonal intrauterine system that meets the effectiveness criteria as stated in the product label.
* Male partner sterilization prior to the female subject's entry into the study, and this male is the sole partner for that subject.
* Combined (oestrogen and progesterone containing) hormonal contraception associated with the inhibition of ovulation\*:
* Oral
* Intravaginal
* Transdermal
* Bilateral tubal occlusion
2. Male or non-pregnant, non-lactating females†.
3. Age ≥ 18 years.
4. Have documented, untreated HIV-1 infection with either:
1. AIDS with any CD4 cell count (AIDS-defining conditions are listed within Appendix 3).
Or
2. Severe bacterial infection (BI)‡ and must have a CD4 cell count \< 200/μl within 28 days prior to study entry§.
Or
3. 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
4. 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.
5. Have an entry HIV viral load \> 1000 copies/mL
6. Have the ability to take oral medications.
7. 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:
* True abstinence from penile-vaginal intercourse, when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods), and withdrawal are not acceptable methods of contraception).
* Non-hormonal Intrauterine device or non-hormonal intrauterine system that meets the effectiveness criteria as stated in the product label.
* Male partner sterilization prior to the female subject's entry into the study, and this male is the sole partner for that subject.
* Combined (oestrogen and progesterone containing) hormonal contraception associated with the inhibition of ovulation\*:
* Oral
* Intravaginal
* Transdermal
* Bilateral tubal occlusion
Exclusion Criteria
1. Any therapeutic ARV which commenced less than 2 weeks prior to screening and which was taken for more than 48 hours
2. Systemic cancer chemotherapy within 30 days prior to study entry, or current treatment for cancer (with the exception of Kaposi's sarcoma) or lymphoma.
3. Current or anticipated use of contraindicated medications (see Summary of Product Characteristics (SmPC) for Symtuza® and Biktarvy®) or anticipated systemic chemotherapy during study enrolment (administration of any contraindicated medication must be discontinued at least 30 days prior to the baseline visit and for the duration of the study).
4. Known resistance to the components of study medications (see section 6.1.3 for more details).
5. History or symptoms of advanced renal and/or hepatic impairment. Such as, kidney failure requiring dialysis; eGFR \<30 mL/min; hepatic transaminases (AST and ALT) \> 5 x upper limit of normal (ULN); or, platelet count \<50,000.
6. Current drug or alcohol use that, in the opinion of the Investigator, would cause interference with the study.
7. Cryptococcal meningitis or active TB, or current or expected treatment requiring Rifampicin or Rifabutin (patients with expected latent TB will have a TB test (IGRAs e.g. ELISPOT, QuantiFERON etc.) at their screening visit).
8. History or presence of allergy to the study drugs or their components, or drugs of their class.
9. Using any concomitant therapy disallowed as per the product labelling for the study drugs.
10. Any investigational drug within 30 days prior to the study drug administration.
11. Patients with severe (Child Pugh class C) hepatic impairment.
12. Women who are pregnant, breastfeeding or plan to become pregnant or breastfeed during the study.
2. Systemic cancer chemotherapy within 30 days prior to study entry, or current treatment for cancer (with the exception of Kaposi's sarcoma) or lymphoma.
3. Current or anticipated use of contraindicated medications (see Summary of Product Characteristics (SmPC) for Symtuza® and Biktarvy®) or anticipated systemic chemotherapy during study enrolment (administration of any contraindicated medication must be discontinued at least 30 days prior to the baseline visit and for the duration of the study).
4. Known resistance to the components of study medications (see section 6.1.3 for more details).
5. History or symptoms of advanced renal and/or hepatic impairment. Such as, kidney failure requiring dialysis; eGFR \<30 mL/min; hepatic transaminases (AST and ALT) \> 5 x upper limit of normal (ULN); or, platelet count \<50,000.
6. Current drug or alcohol use that, in the opinion of the Investigator, would cause interference with the study.
7. Cryptococcal meningitis or active TB, or current or expected treatment requiring Rifampicin or Rifabutin (patients with expected latent TB will have a TB test (IGRAs e.g. ELISPOT, QuantiFERON etc.) at their screening visit).
8. History or presence of allergy to the study drugs or their components, or drugs of their class.
9. Using any concomitant therapy disallowed as per the product labelling for the study drugs.
10. Any investigational drug within 30 days prior to the study drug administration.
11. Patients with severe (Child Pugh class C) hepatic impairment.
12. Women who are pregnant, breastfeeding or plan to become pregnant or breastfeed during the study.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Gilead Sciences
INDUSTRY
Sponsor Role
collaborator
Janssen Pharmaceuticals
INDUSTRY
Sponsor Role
collaborator
NEAT ID Foundation
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Georg Behrens
Role: STUDY_DIRECTOR
Hannover Medical School
Locations
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Institute of Tropical Medicine
Antwerp, , Belgium
Site Status
CHU Saint-Pierre
Brussels, , Belgium
Site Status
University Hospital Ghent
Ghent, , Belgium
Site Status
Hopital Europeen Marseille
Marseille, , France
Site Status
Groupe Hospitalier Sud Ile-de-France (Melun)
Melun, , France
Site Status
Hôpital Gui de Chauliac
Montpellier, , France
Site Status
CHU de Nantes
Nantes, , France
Site Status
Hopital Lariboisiere
Paris, , France
Site Status
Hopital Saint-Louis
Paris, , France
Site Status
Hôpital Saint Antoine
Paris, , France
Site Status
Pitié-Salpêtrière Hospital
Paris, , France
Site Status
Medizinische Klinik und Poliklinik Universitätsklinikum Bonn
Bonn, , Germany
Site Status
University Hospital Koln
Cologne, , Germany
Site Status
Goethe University Hospital Frankfurt
Frankfurt, , Germany
Site Status
University Hospital Geissen
Geißen, , Germany
Site Status
ICH Study Center Gmbh & Co. KG
Hamburg, , Germany
Site Status
Medizinische Hochschule Hannover
Hanover, , Germany
Site Status
University Hospital Klinikum rechts der Isar der TUM
Munich, , Germany
Site Status
Mater Misericordiae University Hospital
Dublin, , Ireland
Site Status
St Vincent's University Hospital
Dublin, , Ireland
Site Status
Luigi Sacco Hospital
Milan, , Italy
Site Status
Ospedale San Raffaele
Milan, , Italy
Site Status
ASST Santi Paolo
Milan, , Italy
Site Status
Clinica of Infectious Diseases
Modena, , Italy
Site Status
INMI Lazzaro Spallanzani, Rome
Rome, , Italy
Site Status
Hospital General Universatario Alicante
Alicante, , Spain
Site Status
Hospital Bellvitge
Barcelona, , Spain
Site Status
Hospital Clinic (Helios Building)
Barcelona, , Spain
Site Status
Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Site Status
Hospital del Mar
Barcelona, , Spain
Site Status
Hospital Trias i Pujol
Barcelona, , Spain
Site Status
Hospital Universitari Vall d'Herbon
Barcelona, , Spain
Site Status
Hospital General Universitatrio de Elche
Elche, , Spain
Site Status
Hospital 12 Octubre
Madrid, , Spain
Site Status
Hospital de la Princesa
Madrid, , Spain
Site Status
Hospital Ramon y Cajal
Madrid, , Spain
Site Status
Hospital Universitatrio La Paz
Madrid, , Spain
Site Status
Hospital Virgen de la Victoria
Málaga, , Spain
Site Status
Royal Bournemouth Hospital
Bournemouth, , United Kingdom
Site Status
Southmead Hospital
Bristol, , United Kingdom
Site Status
Leeds Teaching Hospital
Leeds, , United Kingdom
Site Status
Barts Health
London, , United Kingdom
Site Status
Chelsea and Westminister
London, , United Kingdom
Site Status
Guy's Hospital
London, , United Kingdom
Site Status
Homerton University Hospital
London, , United Kingdom
Site Status
Imperial College Healthcare Trust
London, , United Kingdom
Site Status
Kings College London
London, , United Kingdom
Site Status
Mortimer Market Centre
London, , United Kingdom
Site Status
Royal Free Hospital
London, , United Kingdom
Site Status
St George's Hospital
London, , United Kingdom
Site Status
University Hospital Lewisham
London, , United Kingdom
Site Status
North Manchester General Hospital
Manchester, , United Kingdom
Site Status
Sheffield Teaching Hospital
Sheffield, , United Kingdom
Site Status
Countries
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Belgium
France
Germany
Ireland
Italy
Spain
United Kingdom
References
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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.
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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
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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
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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)
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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.
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BACKGROUND
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. 2025 Dec 1:S1473-3099(25)00681-4. doi: 10.1016/S1473-3099(25)00681-4. Online ahead of print.
Reference Type
DERIVED
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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NEAT44
Identifier Type: -
Identifier Source: org_study_id