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Human Immunodeficiency Virus

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1. Dolutegravir/lamivudine (Dovato) - Human Immunodeficiency Virus type 1 (HIV-1)

Dolutegravir/lamivudine (Dovato) - Human Immunodeficiency Virus type 1 (HIV-1) Final Appraisal Recommendation Advice No: 0220 – February 2020 Dolutegravir/lamivudine (Dovato ® ) 50 mg/300 mg film-coated tablets Limited submission by ViiV Healthcare UK Ltd In reaching the above recommendation AWMSG has taken account of the appraisal documentation prepared by the AWMSG Secretariat (reference number 3659), which includes the AWMSG Secretariat Assessment Report (ASAR), the Preliminary Appraisal (...) Recommendation (PAR) and the applicant company’s response to the PAR, clinical expert opinion (where available), the views of patients/patient carers (where available) and the lay member perspective. This recommendation has been ratified by Welsh Government and will be considered for review every three years. Recommendation of AWMSG Dolutegravir/lamivudine (Dovato ® ) is recommended as an option for use within NHS Wales for the treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection in adults

2020 All Wales Medicines Strategy Group

2. Dolutegravir/rilpivirine (Juluca) for the treatment of human immunodeficiency virus type 1 (HIV-1)

Dolutegravir/rilpivirine (Juluca) for the treatment of human immunodeficiency virus type 1 (HIV-1) AWMSG SECRETARIAT ASSESSMENT REPORT Dolutegravir/rilpivirine (Juluca ® ) 50 mg/25 mg film-coated tablet Reference number: 2850 FULL SUBMISSION This report has been prepared by the All Wales Therapeutics & Toxicology Centre (AWTTC). Please direct any queries to AWTTC: All Wales Therapeutics & Toxicology Centre (AWTTC) University Hospital Llandough Penlan Road Llandough Vale of Glamorgan CF64 2XX (...) /rilpivirine (Juluca ® ? ) 50 mg/25 mg film-coated tablet 1.0 KEY FACTS Assessment details Dolutegravir/rilpivirine (Juluca ® ? ) for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults who are virologically suppressed (HIV-1 RNA 50 copies/ml but lower than 200 copies/ml in the past 12 months 11 . Previous antiretroviral therapy regimens of two nucleoside reverse transcriptase inhibitors plus a third medicine (a non-nucleoside reverse transcriptase inhibitor, an integrase

2019 All Wales Medicines Strategy Group

3. Doravirine (Pifeltro) - for the treatment of adults infected with human immunodeficiency virus-1 (HIV-1)

Doravirine (Pifeltro) - for the treatment of adults infected with human immunodeficiency virus-1 (HIV-1) Search Page - Drug and Health Product Register Language selection Search and menus Search Search website Search Topics menu You are here: Summary Basis of Decision - - Health Canada Expand all Summary Basis of Decision (SBD) for Contact: Summary Basis of Decision (SBD) documents provide information related to the original authorization of a product. The for is located below. Recent Activity

2019 Health Canada - Drug and Health Product Register

4. Lopinavir/ritonavir (Kaletra) - human immunodeficiency virus (HIV-1) infected children aged from 14 days to less than 2 years old.

Lopinavir/ritonavir (Kaletra) - human immunodeficiency virus (HIV-1) infected children aged from 14 days to less than 2 years old. Lopinavir/ritonavir (Kaletra ® ). Reference number 3557 Page 1 of 3 Enc 7 Appx 2 AWMSG Secretariat Assessment Report – Limited submission Lopinavir/ritonavir (Kaletra ® ) 80 mg/20 mg oral solution Company: AbbVie Ltd. Licensed indication under consideration: In combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (...) antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infected children aged from 14 days to less than 2 years old. Lopinavir/ritonavir oral solution is already licensed for use in patients aged 2 years and over in the same indication and is included on Welsh health board formularies. Marketing authorisation for this older age group was granted before 1 October 2010, and was not appraised by the All Wales Medicines Strategy Group (AWMSG) as it did not meet the criteria

2018 All Wales Medicines Strategy Group

5. Darunavir/cobicistat/emtricitabine/tenofovir alafenamide (Symtuza) - Human immunodeficiency virus type 1 (HIV-1) infection in adults and adolescents

Darunavir/cobicistat/emtricitabine/tenofovir alafenamide (Symtuza) - Human immunodeficiency virus type 1 (HIV-1) infection in adults and adolescents Darunavir/cobicistat/emtricitabine/tenofovir alafenamide (Symtuza ® ). Reference number 2418. Page 1 of 3 Enc 9 Appx 2 AWMSG Secretariat Assessment Report – Limited submission Darunavir/cobicistat/emtricitabine/tenofovir alafenamide (Symtuza ®? ) 800 mg/150 mg/200 mg/10 mg film-coated tablet Company: Janssen-Cilag Ltd Licensed indication under (...) consideration: Treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and adolescents (aged 12 years and older with body weight at least 40 kg). ? This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. Marketing authorisation date: 26 September 2017 Comparator(s) ? Darunavir/cobicistat (Rezolsta ® ) in combination with emtricitabine

2018 All Wales Medicines Strategy Group

6. Bictegravir/emtricitabine/tenofovir alafenamide (Biktarvy) adults infected with human immunodeficiency virus-1 (HIV-1)

Bictegravir/emtricitabine/tenofovir alafenamide (Biktarvy) adults infected with human immunodeficiency virus-1 (HIV-1) AWMSG SECRETARIAT ASSESSMENT REPORT Bictegravir/emtricitabine/tenofovir alafenamide (Biktarvy ® ) 50 mg/200 mg/25 mg film-coated tablets Reference number: 3414 FULL SUBMISSION This report has been prepared by the All Wales Therapeutics & Toxicology Centre (AWTTC). Please direct any queries to AWTTC: All Wales Therapeutics & Toxicology Centre (AWTTC) University Hospital (...) from the date of the Final Appraisal Recommendation. AWMSG Secretariat Assessment Report Bictegravir/emtricitabine/tenofovir alafenamide (Biktarvy ® ? ) 50 mg/200 mg/25 mg film-coated tablets 1.0 KEY FACTS Assessment details Bictegravir/emtricitabine/tenofovir alafenamide (Biktarvy ® ? ) for the treatment of adults infected with human immunodeficiency virus-1 (HIV-1) without present or past evidence of viral resistance to the integrase inhibitor class, emtricitabine or tenofovir. ?This medicinal

2018 All Wales Medicines Strategy Group

7. Bictegravir, emtricitabine and tenofovir alafenamide (Biktarvy) - for the treatment of human immunodeficiency virus-1 (HIV-1)

Bictegravir, emtricitabine and tenofovir alafenamide (Biktarvy) - for the treatment of human immunodeficiency virus-1 (HIV-1) Search Page - Drug and Health Product Register Language selection Search and menus Search Search website Search Topics menu You are here: Summary Basis of Decision - - Health Canada Expand all Summary Basis of Decision (SBD) for Contact: Summary Basis of Decision (SBD) documents provide information related to the original authorization of a product. The for is located

2018 Health Canada - Drug and Health Product Register

8. Dolutegravir lamivudine (Dovato) - human immunodeficiency virus type 1 (HIV-1)

Dolutegravir lamivudine (Dovato) - human immunodeficiency virus type 1 (HIV-1) Published 9 September 2019 1 Product update SMC2205 dolutegravir 50mg / lamivudine 300mg film-coated tablets (Dovato®) ViiV Healthcare Ltd 9 August 2019 The Scottish Medicines Consortium (SMC) has completed its assessment of the above product and advises NHS Boards and Area Drug and Therapeutic Committees (ADTCs) on its use in NHSScotland. The advice is summarised as follows: ADVICE: following an abbreviated (...) submission dolutegravir / lamivudine (Dovato®) is accepted for use within NHSScotland. Indication under review: for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and adolescents above 12 years of age weighing at least 40kg, with no known or suspected resistance to the integrase inhibitor class, or lamivudine. In patients for whom this two-drug combination regimen is appropriate dolutegravir / lamivudine (Dovato®) offers a single tablet at no additional cost compared

2019 Scottish Medicines Consortium

9. Management of newborns born to women with HIV (Human Immunodeficiency Virus) infection

Management of newborns born to women with HIV (Human Immunodeficiency Virus) infection Management of newborns born to women with HIV (Human Immunodeficiency Virus) infection Document ID CHQ-GDL-01243 Version no. 3.1 Approval date 28/05/2019 Executive sponsor Executive Director Medical Services Effective date 28/05/2019 Author/custodian Infectious Diseases Physician - Infection Management and Prevention services Review date 28/05/2021 Supercedes 3.0 Applicable to All Children’s Health Queensland (...) staff Authorisation Executive Director Clinical Services (QCH) Purpose This guideline provides best practice recommendations for obstetricians, paediatricians, neonatologists and Human Immunodeficient Virus (HIV) physicians regarding management of infants born to women with HIV infection. Scope This Guideline provides information for all Children’s Health Queensland (CHQ) employees (permanent, temporary and casual) and all organisations and individuals acting as its agents (including Visiting

2019 Queensland Health

10. Doravirine/lamivudine/tenofovir disoproxil (Delstrigo) - Treatment of adults infected with human immunodeficiency virus 1

Doravirine/lamivudine/tenofovir disoproxil (Delstrigo) - Treatment of adults infected with human immunodeficiency virus 1 Published 11 February 2019 Statement of advice SMC2163 doravirine 100mg / lamivudine 300mg / tenofovir disoproxil 245mg film-coated tablets (Delstrigo®) Merck Sharp & Dohme Limited 11 January 2019 ADVICE: in the absence of a submission from the holder of the marketing authorisation doravirine / lamivudine / tenofovir disoproxil (Delstrigo®) is not recommended for use within (...) NHSScotland. Indication under review: Treatment of adults infected with human immunodeficiency virus 1 without past or present evidence of resistance to the non-nucleoside reverse transcriptase inhibitor class, lamivudine, or tenofovir. The holder of the marketing authorisation has not made a submission to SMC regarding this product in this indication. As a result we cannot recommend its use within NHSScotland. Advice context: No part of this advice may be used without the whole of the advice being quoted

2019 Scottish Medicines Consortium

11. Doravirine (Pifeltro) - treatment of adults infected with human immunodeficiency virus 1

Doravirine (Pifeltro) - treatment of adults infected with human immunodeficiency virus 1 Published 11 February 2019 Statement of advice SMC2162 doravirine 100mg film-coated tablets (Pifeltro®) Merck Sharp & Dohme Limited 11 January 2019 ADVICE: in the absence of a submission from the holder of the marketing authorisation doravirine (Pifeltro®) is not recommended for use within NHSScotland. Indication under review: In combination with other antiretroviral medicinal products, for the treatment (...) of adults infected with human immunodeficiency virus 1 without past or present evidence of resistance to the non-nucleoside reverse transcriptase inhibitor class. The holder of the marketing authorisation has not made a submission to SMC regarding this product in this indication. As a result we cannot recommend its use within NHSScotland. Advice context: No part of this advice may be used without the whole of the advice being quoted in full. This advice represents the view of the Scottish Medicines

2019 Scottish Medicines Consortium

12. Human Immunodeficiency Virus (HIV) Infection: Screening

Human Immunodeficiency Virus (HIV) Infection: Screening Recommendation | United States Preventive Services Taskforce Toggle navigation Main navigation Main navigation Recommendation Pregnant persons The USPSTF recommends that clinicians screen for HIV infection in all pregnant persons, including those who present in labor or at delivery whose HIV status is unknown. A Adolescents and adults aged 15 to 65 years The USPSTF recommends that clinicians screen for HIV infection in adolescents (...) . In addition, ART treatment in pregnant persons living with HIV and use of other precautions substantially decrease the risk of transmission to the fetus, newborn, or infant. Abbreviations: ACOG=American College of Obstetricians and Gynecologists; AIDS=acquired immunodeficiency syndrome; ART=antiretroviral therapy; CDC=Centers for Disease Prevention and Control; HIV= human immunodeficiency virus; STI=sexually transmitted infection. For a summary of the evidence systematically reviewed in making

2019 U.S. Preventive Services Task Force

13. Prevention of Human Immunodeficiency Virus (HIV) Infection: Preexposure Prophylaxis

Prevention of Human Immunodeficiency Virus (HIV) Infection: Preexposure Prophylaxis Recommendation | United States Preventive Services Taskforce Toggle navigation Main navigation Main navigation Recommendation Persons at high risk of HIV acquisition The USPSTF recommends that clinicians offer preexposure prophylaxis (PrEP) with effective antiretroviral therapy to persons who are at high risk of HIV acquisition. A View the Clinical Summary in Population Persons at high risk of HIV acquisition (...) Once-daily oral treatment with combined tenofovir disoproxil fumarate and emtricitabine is the only formulation of PrEP currently approved by the US Food and Drug Administration for use in the United States in persons at risk of sexual acquisition of HIV infection. Relevant USPSTF Recommendations The USPSTF has issued recommendations on behavioral counseling to reduce risk of STIs and on screening for HIV infection. Abbreviations: HIV=human immunodeficiency virus; STI=sexually transmitted infection

2019 U.S. Preventive Services Task Force

14. Dolutegravir (Tivicay) - Human Immunodeficiency Virus (HIV)

Dolutegravir (Tivicay) - Human Immunodeficiency Virus (HIV) Final Appraisal Recommendation Advice No: 2017 – October 2017 Dolutegravir (Tivicay ® ) 10 mg, 25 mg and 50 mg film-coated tablets Limited submission by ViiV Healthcare UK Ltd Additional note(s): ? This advice incorporates and replaces the existing AWMSG recommendation on dolutegravir (Tivicay ® ) for the treatment of Human Immunodeficiency Virus (HIV) infected adults and adolescents above 12 years of age (Advice number 2314 (...) anti-retroviral medicinal products for the treatment of Human Immunodeficiency Virus (HIV) infected adults, adolescents and children above 6 years of age. This recommendation applies only in circumstances where the approved Wales Patient Access Scheme (WPAS) is utilised or where the list/contract price is equivalent or lower than the WPAS price.

2017 All Wales Medicines Strategy Group

15. Prenatal and Perinatal Human Immunodeficiency Virus Testing - Expanded Recommendations

Prenatal and Perinatal Human Immunodeficiency Virus Testing - Expanded Recommendations Prenatal and Perinatal Human Immunodeficiency Virus Testing - Expanded Recommendations - ACOG Menu ▼ Prenatal and Perinatal Human Immunodeficiency Virus Testing - Expanded Recommendations Page Navigation ▼ INTERIM UPDATE Number 752 (Replaces Committee Opinion No. 635, June 2015) Committee on Obstetric Practice HIV Expert Work Group This Committee Opinion was developed by the American College of Obstetricians (...) by those organizations. The American College of Obstetricians and Gynecologists has neither solicited nor accepted any commercial involvement in the development of the content of this published product. INTERIM UPDATE: This Committee Opinion is updated as highlighted to reflect a limited, focused change in the language and evidence regarding opt-out testing, repeat testing, rapid testing, and hepatitis A testing. Prenatal and Perinatal Human Immunodeficiency Virus Testing ABSTRACT: Given the enormous

2018 American College of Obstetricians and Gynecologists

16. Labor and Delivery Management of Women With Human Immunodeficiency Virus Infection

Labor and Delivery Management of Women With Human Immunodeficiency Virus Infection Labor and Delivery Management of Women With Human Immunodeficiency Virus Infection - ACOG Menu ▼ Labor and Delivery Management of Women With Human Immunodeficiency Virus Infection Page Navigation ▼ Number 751 (Replaces Committee Opinion No. 234, May 2000) Committee on Obstetric Practice HIV Expert Work Group The Society for Maternal–Fetal Medicine endorses this document. This Committee Opinion was developed (...) with other organizations, conflict of interest disclosures by representatives of the other organizations are addressed by those organizations. The American College of Obstetricians and Gynecologists has neither solicited nor accepted any commercial involvement in the development of the content of this published product. Labor and Delivery Management of Women With Human Immunodeficiency Virus Infection ABSTRACT: This Committee Opinion is being revised to provide updated guidance on the management

2018 American College of Obstetricians and Gynecologists

17. Dolutegravir rilpivirine (Juluca) - For the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults who are virologically suppressed (HIV-1 RNA copies <50 copies/mL) on a stable antiretroviral regimen

Dolutegravir rilpivirine (Juluca) - For the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults who are virologically suppressed (HIV-1 RNA copies <50 copies/mL) on a stable antiretroviral regimen Published 10 September 2018 1 dolutegravir 50mg / rilpivirine 25mg film-coated tablets (Juluca ® ) SMC2091 ViiV Healthcare Ltd. 10 August 2018 The Scottish Medicines Consortium (SMC) has completed its assessment of the above product and advises NHS Boards and Area Drug (...) and Therapeutic Committees (ADTCs) on its use in NHS Scotland. The advice is summarised as follows: ADVICE: following a full submission dolutegravir / rilpivirine film-coated tablet (Juluca ® ) is accepted for use within NHSScotland. Indication under review: The treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults who are virologically-suppressed (HIV-1 RNA 50 copies/mL in the 6-month period before screening and no more than one instance of viral load >50 copies/mL but <200 copies/mL

2018 Scottish Medicines Consortium

18. Raltegravir (Isentress) - human immunodeficiency virus in neonates

Raltegravir (Isentress) - human immunodeficiency virus in neonates Published 9 July 2018 Statement of Advice: raltegravir 100mg granules for oral suspension (Isentress ® ) SMC2101 Merck Sharp & Dohme Limited 8 June 2018 ADVICE: in the absence of a submission from the holder of the marketing authorisation raltegravir (Isentress ® ) is not recommended for use within NHSScotland. Indication under review: in combination with other anti-retroviral medicinal products in the treatment of human (...) immunodeficiency virus in neonates. The holder of the marketing authorisation has not made a submission to SMC regarding this product in this setting. As a result we cannot recommend its use within NHSScotland. Advice context: No part of this advice may be used without the whole of the advice being quoted in full. This advice represents the view of the Scottish Medicines Consortium. It is provided to inform the considerations of Area Drug & Therapeutics Committees and NHS Boards in Scotland in determining

2018 Scottish Medicines Consortium

19. Elvitegravir / cobicistat / emtricitabine / tenofovir alafenamide (Genvoya) - human immunodeficiency virus-1 (HIV-1)

Elvitegravir / cobicistat / emtricitabine / tenofovir alafenamide (Genvoya) - human immunodeficiency virus-1 (HIV-1) Published 12 March 2018 Statement of Advice: elvitegravir 150mg / cobicistat 150mg / emtricitabine 200mg / tenofovir alafenamide 10mg (Genvoya ® ) SMC No 1323/18 Gilead Sciences Ltd 9 February 2018 ADVICE: in the absence of a submission from the holder of the marketing authorisation elvitegravir / cobicistat / emtricitabine / tenofovir alafenamide (Genvoya ® ) is not recommended (...) for use within NHS Scotland. Indication under review: Treatment of human immunodeficiency virus-1 (HIV-1) infection without any known mutations associated with resistance to the integrase inhibitor class, emtricitabine or tenofovir in children aged from 6 years and with body weight at least 25 kg for whom alternative regimens are unsuitable due to toxicities. The holder of the marketing authorisation has not made a submission to SMC regarding this product in this setting. As a result we cannot

2018 Scottish Medicines Consortium

20. Efficacy of a Clinic-Based Safer Sex Program for Human Immunodeficiency Virus-Uninfected and Human Immunodeficiency Virus-Infected Young Black Men Who Have Sex With Men: A Randomized Controlled Trial. (Abstract)

Efficacy of a Clinic-Based Safer Sex Program for Human Immunodeficiency Virus-Uninfected and Human Immunodeficiency Virus-Infected Young Black Men Who Have Sex With Men: A Randomized Controlled Trial. To test the efficacy of a single-session, clinic-based intervention designed to promote condom use among young black men who have sex with men (YBMSM).Six hundred YBMSM were enrolled in a randomized controlled trial, using a 12-month observation period. An intent-to-treat analysis was performed (...) , with multiple imputation for missing data.Compared with the reference group, human immunodeficiency virus (HIV)-infected men in the intervention group had 64% greater odds of reporting consistent condom use for anal receptive sex over 12 months (estimated odds ratio, 1.64; 95% confidence interval, 1.23-2.17, P = 0.001). Also, compared with the reference group, HIV-uninfected men in the intervention group had more than twice the odds of reporting consistent condom use for anal receptive sex over 12 months

2019 Sexually transmitted diseases Controlled trial quality: uncertain

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