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Prevention of Secondary Infection in HIV

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

=pages/medicines/human/medici nes/004449/human_med_002263.jsp&mid=WC0b01ac058001d124. Accessed Jul 2018. 3. Campbell-Yesufu OT, and Gandhi RT. Update on human immunodeficiency virus (HIV)-2 infection. Clinical Infectious Diseases. 2011;52(6):780-787. 4. British HIV Association. Guidelines for the treatment of HIV-1-positive adults with antiretroviral therapy 2015 (2016 interim update). Available at: http://www.bhiva.org/HIV-1-treatment-guidelines.aspx. 5. Gilead Sciences Ltd. Biktarvy ® . Summary (...) 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

2018 All Wales Medicines Strategy Group

2. 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

3. A Study to Assess the Efficacy of a Heterologous Prime/Boost Vaccine Regimen of Ad26.Mos4.HIV and Aluminum Phosphate-Adjuvanted Clade C gp140 in Preventing Human Immunodeficiency Virus (HIV) -1 Infection in Women in Sub-Saharan Africa

A Study to Assess the Efficacy of a Heterologous Prime/Boost Vaccine Regimen of Ad26.Mos4.HIV and Aluminum Phosphate-Adjuvanted Clade C gp140 in Preventing Human Immunodeficiency Virus (HIV) -1 Infection in Women in Sub-Saharan Africa A Study to Assess the Efficacy of a Heterologous Prime/Boost Vaccine Regimen of Ad26.Mos4.HIV and Aluminum Phosphate-Adjuvanted Clade C gp140 in Preventing Human Immunodeficiency Virus (HIV) -1 Infection in Women in Sub-Saharan Africa - Full Text View (...) - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please remove one or more studies before adding more. A Study to Assess the Efficacy of a Heterologous Prime/Boost Vaccine Regimen of Ad26.Mos4.HIV and Aluminum Phosphate-Adjuvanted Clade C gp140 in Preventing Human Immunodeficiency Virus (HIV) -1

2017 Clinical Trials

4. Safety and Efficacy of Dolutegravir/Lamivudine (DTG/3TC) in Therapy-naive Human Immunodeficiency Virus-1 (HIV-1) Infected Adolescents

Safety and Efficacy of Dolutegravir/Lamivudine (DTG/3TC) in Therapy-naive Human Immunodeficiency Virus-1 (HIV-1) Infected Adolescents Safety and Efficacy of Dolutegravir/Lamivudine (DTG/3TC) in Therapy-naive Human Immunodeficiency Virus-1 (HIV-1) Infected Adolescents - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You (...) have reached the maximum number of saved studies (100). Please remove one or more studies before adding more. Safety and Efficacy of Dolutegravir/Lamivudine (DTG/3TC) in Therapy-naive Human Immunodeficiency Virus-1 (HIV-1) Infected Adolescents The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. of clinical studies and talk to your health care provider before

2018 Clinical Trials

5. A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 Followed by PNEUMOVAXâ„¢23 in Adults Infected With Human Immunodeficiency Virus (HIV) (V114-018/PNEU-WAY)

A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 Followed by PNEUMOVAXâ„¢23 in Adults Infected With Human Immunodeficiency Virus (HIV) (V114-018/PNEU-WAY) A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 Followed by PNEUMOVAX™23 in Adults Infected With Human Immunodeficiency Virus (HIV) (V114-018/PNEU-WAY) - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results (...) information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please remove one or more studies before adding more. A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 Followed by PNEUMOVAX™23 in Adults Infected With Human Immunodeficiency Virus (HIV) (V114-018/PNEU-WAY) The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study

2018 Clinical Trials

6. A Study of 2 Different Regimens of Tetravalent Ad26.Mos4.HIV Prime Followed by Boost With Modified Vaccinia Ankara (MVA)-Mosaic OR Ad26.Mos4.HIV Plus a Combination of Mosaic and Clade C gp140 Protein in Human Immunodeficiency Virus (HIV) Type 1 Infected A

A Study of 2 Different Regimens of Tetravalent Ad26.Mos4.HIV Prime Followed by Boost With Modified Vaccinia Ankara (MVA)-Mosaic OR Ad26.Mos4.HIV Plus a Combination of Mosaic and Clade C gp140 Protein in Human Immunodeficiency Virus (HIV) Type 1 Infected A A Study of 2 Different Regimens of Tetravalent Ad26.Mos4.HIV Prime Followed by Boost With Modified Vaccinia Ankara (MVA)-Mosaic OR Ad26.Mos4.HIV Plus a Combination of Mosaic and Clade C gp140 Protein in Human Immunodeficiency Virus (HIV) Type (...) Vaccinia Ankara (MVA)-Mosaic OR Ad26.Mos4.HIV Plus a Combination of Mosaic and Clade C gp140 Protein in Human Immunodeficiency Virus (HIV) Type 1 Infected Adults on Suppressive Antiretroviral Treatment The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. of clinical studies and talk to your health care provider before participating. Read our for details

2017 Clinical Trials

7. TAILoR (TelmisArtan and InsuLin Resistance in Human Immunodeficiency Virus [HIV]): An Adaptive-design, Dose-ranging Phase IIb Randomized Trial of Telmisartan for the Reduction of Insulin Resistance in HIV-positive Individuals on Combination Antiretroviral Full Text available with Trip Pro

TAILoR (TelmisArtan and InsuLin Resistance in Human Immunodeficiency Virus [HIV]): An Adaptive-design, Dose-ranging Phase IIb Randomized Trial of Telmisartan for the Reduction of Insulin Resistance in HIV-positive Individuals on Combination Antiretroviral Combination antiretroviral therapy results in metabolic abnormalities which increase cardiovascular disease risk. We evaluated whether telmisartan reduces insulin resistance in human immunodeficiency virus (HIV)-positive individuals (...) on antiretrovirals.We conducted a multicenter, randomized, open-label, dose-ranging controlled trial of telmisartan. Participants with HIV infection receiving combination antiretroviral therapy were randomized equally to either no intervention (control) or 20, 40, or 80 mg telmisartan once daily. The adaptive design allowed testing of all dose(s) of telmisartan in stage I, with the promising dose(s) being taken into stage II. The primary outcome measure was reduction in homeostasis model assessment of insulin

2019 Clinical Infectious Diseases Controlled trial quality: uncertain

8. Incidence of Human Immunodeficiency Virus-1 (HIV-1) Infection in HIV-1 Uninfected High Risk Men Who Have Sex With Men

Incidence of Human Immunodeficiency Virus-1 (HIV-1) Infection in HIV-1 Uninfected High Risk Men Who Have Sex With Men Incidence of Human Immunodeficiency Virus-1 (HIV-1) Infection in HIV-1 Uninfected High Risk Men Who Have Sex With Men - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number (...) of saved studies (100). Please remove one or more studies before adding more. Incidence of Human Immunodeficiency Virus-1 (HIV-1) Infection in HIV-1 Uninfected High Risk Men Who Have Sex With Men The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our for details. ClinicalTrials.gov Identifier: NCT03310515 Recruitment Status : Completed First Posted

2017 Clinical Trials

9. Efficacy, Safety and Tolerability Study of Long-acting Cabotegravir Plus Long-acting Rilpivirine (CAB LA + RPV LA) in Human-immunodeficiency Virus-1 (HIV-1) Infected Adults

Efficacy, Safety and Tolerability Study of Long-acting Cabotegravir Plus Long-acting Rilpivirine (CAB LA + RPV LA) in Human-immunodeficiency Virus-1 (HIV-1) Infected Adults Efficacy, Safety and Tolerability Study of Long-acting Cabotegravir Plus Long-acting Rilpivirine (CAB LA + RPV LA) in Human-immunodeficiency Virus-1 (HIV-1) Infected Adults - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information (...) . Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please remove one or more studies before adding more. Efficacy, Safety and Tolerability Study of Long-acting Cabotegravir Plus Long-acting Rilpivirine (CAB LA + RPV LA) in Human-immunodeficiency Virus-1 (HIV-1) Infected Adults The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does

2017 Clinical Trials

10. Safety and Efficacy Study of GSK2838232 in Human Immunodeficiency Virus (HIV)-1 Infected Adults

Safety and Efficacy Study of GSK2838232 in Human Immunodeficiency Virus (HIV)-1 Infected Adults Safety and Efficacy Study of GSK2838232 in Human Immunodeficiency Virus (HIV)-1 Infected Adults - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please remove one (...) or more studies before adding more. Safety and Efficacy Study of GSK2838232 in Human Immunodeficiency Virus (HIV)-1 Infected Adults The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our for details. ClinicalTrials.gov Identifier: NCT03045861 Recruitment Status : Completed First Posted : February 8, 2017 Last Update Posted : June 12, 2018 Sponsor

2017 Clinical Trials

11. Pomalidomide in Treating Patients With Kaposi Sarcoma and Human Immunodeficiency Virus Infection

and human immunodeficiency virus (HIV) infection. Biological therapies, such as pomalidomide, may stimulate the immune system in different ways and stop tumor cells from growing and it may also block the growth of new blood vessels necessary for tumor growth. Condition or disease Intervention/treatment Phase Human Immunodeficiency Virus 1 Positive Skin Kaposi Sarcoma Other: Laboratory Biomarker Analysis Drug: Pomalidomide Phase 2 Detailed Description: PRIMARY OBJECTIVES: I. To determine if pomalidomide (...) ] The binomial proportion and its 95% exact confidence interval will be used to estimate the proportion of participants who experience a grade 3 or higher toxicity. Secondary Outcome Measures : Changes in CD4 T cell count [ Time Frame: Baseline to up to 30 days after last dose of study drug ] Changes in CD4 counts and human immunodeficiency virus (HIV) viral load will be evaluated using generalized estimating equations. Changes in HIV viral load as measured by HIV quantitative polymerase chain reaction

2018 Clinical Trials

12. Phase 2b, Open-label, Multicenter, Rollover Study to Assess Antiviral Activity and Safety of Long-acting Cabotegravir (CAB LA) Plus Long-acting Rilpivirine (RPV LA), Administered Every 2 Months (Q2M), in Human Immunodeficiency Virus (HIV)- Positive Subjec

Phase 2b, Open-label, Multicenter, Rollover Study to Assess Antiviral Activity and Safety of Long-acting Cabotegravir (CAB LA) Plus Long-acting Rilpivirine (RPV LA), Administered Every 2 Months (Q2M), in Human Immunodeficiency Virus (HIV)- Positive Subjec Phase 2b, Open-label, Multicenter, Rollover Study to Assess Antiviral Activity and Safety of Long-acting Cabotegravir (CAB LA) Plus Long-acting Rilpivirine (RPV LA), Administered Every 2 Months (Q2M), in Human Immunodeficiency Virus (HIV (...) ) Plus Long-acting Rilpivirine (RPV LA), Administered Every 2 Months (Q2M), in Human Immunodeficiency Virus (HIV)- Positive Subjects From the LATTE Study The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. of clinical studies and talk to your health care provider before participating. Read our for details. ClinicalTrials.gov Identifier: NCT03639311 Recruitment

2018 Clinical Trials

13. A Safety, Tolerability, Acceptability, and Pharmacokinetic (PK) Study of Cabotegravir (CAB) in Healthy Human Immunodeficiency Virus (HIV)-Uninfected Chinese Men

: No Product Manufactured in and Exported from the U.S.: Yes Keywords provided by ViiV Healthcare: GSK1265744 Pre-Exposure Prophylaxis Human immunodeficiency virus Cabotegravir Pharmacokinetics Additional relevant MeSH terms: Layout table for MeSH terms HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases (...) A Safety, Tolerability, Acceptability, and Pharmacokinetic (PK) Study of Cabotegravir (CAB) in Healthy Human Immunodeficiency Virus (HIV)-Uninfected Chinese Men A Safety, Tolerability, Acceptability, and Pharmacokinetic (PK) Study of Cabotegravir (CAB) in Healthy Human Immunodeficiency Virus (HIV)-Uninfected Chinese Men - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study

2018 Clinical Trials

14. A systematic review of human immunodeficiency virus (HIV)/sexually transmitted infection (STI) prevention interventions in entertainment/alcohol-serving establishments and brothels targeting heterosexual men who engage in casual or paid sex

A systematic review of human immunodeficiency virus (HIV)/sexually transmitted infection (STI) prevention interventions in entertainment/alcohol-serving establishments and brothels targeting heterosexual men who engage in casual or paid sex Print | PDF PROSPERO This information has been provided by the named contact for this review. CRD has accepted this information in good faith and registered the review in PROSPERO. CRD bears no responsibility or liability for the content of this registration (...) by Jablonski scale; continuous; Jablonski score. ">Data to be extracted: secondary outcome(s) Example: 1st author, year of publication, language, journal. ">Data to be extracted: other as well as a to meta-analysis of pre-clinical studies are available. Example: A meta‐analysis will be performed for all outcome measures reported in 10 or more articles. For subgroup analysis a minimum of 8 studies per subgroup is required. If meta‐analysis is not possible, data will be reported through a descriptive summary

2017 PROSPERO

15. Gynecologic Care for Women and Adolescents With Human Immunodeficiency Virus

to the institution or type of practice. Gynecologic Care for Women and Adolescents With Human Immunodeficiency Virus In the United States in 2013, there were an estimated 226,000 women and adolescents living with human immunodeficiency virus (HIV) infection ( ). Women with HIV are living longer, healthier lives, so the need for routine and problem-focused gynecologic care has increased. The purpose of this document is to educate clinicians about basic health screening and care, family planning, prepregnancy care (...) without HIV. However, co-infected patients may have a delay in resolution of symptoms and may require more prolonged therapy (24). Syphilis Women infected with HIV should be screened with syphilis testing at entry to care and at least annually thereafter. Interpretation of treponemal and nontreponemal serologic test results for syphilis does not differ between HIV-infected and noninfected women. Human immunodeficiency virus may be associated with a higher risk of false-positive nontreponemal serologic

2016 American College of Obstetricians and Gynecologists

16. A randomized controlled trial of azithromycin and sulphadoxine-pyrimethamine as prophylaxis against malaria in pregnancy among human immunodeficiency virus-positive women. (Abstract)

A randomized controlled trial of azithromycin and sulphadoxine-pyrimethamine as prophylaxis against malaria in pregnancy among human immunodeficiency virus-positive women. Malaria and human immunodeficiency virus (HIV) infections in pregnancy are important and major contributing factors to maternal morbidity and mortality in sub-Saharan Africa. Prevention of malaria in HIV-positive pregnant woman will reduce the burden of malaria-HIV comorbidity. The objective of this study was to compare (...) effects and safety of azithromycin (AZ) with sulphadoxine-pyrimethamine (SP) for intermittent preventive therapy for malaria in HIV-positive pregnant women.We performed a randomized, controlled, open-label pregnancy trial of 140 HIV-positive pregnant patients attending antenatal clinics at the University College Hospital and Adeoyo Maternity Teaching Hospital, Ibadan, Nigeria. Participants were enrolled from a gestational age of 16 weeks and randomized to receive AZ or SP. The primary outcome

2019 Transactions of the Royal Society of Tropical Medicine & Hygiene Controlled trial quality: predicted high

17. Switch Study to Evaluate Dolutegravir Plus Lamivudine in Virologically Suppressed Human Immunodeficiency Virus Type 1 Positive Adults (TANGO)

health care provider before participating. Read our for details. ClinicalTrials.gov Identifier: NCT03446573 Recruitment Status : Recruiting First Posted : February 27, 2018 Last Update Posted : November 28, 2018 See Sponsor: ViiV Healthcare Collaborator: GlaxoSmithKline Information provided by (Responsible Party): ViiV Healthcare Study Details Study Description Go to Brief Summary: The aim of the study is to establish if human immunodeficiency virus type 1 (HIV-1) infected adult subjects with current (...) Switch Study to Evaluate Dolutegravir Plus Lamivudine in Virologically Suppressed Human Immunodeficiency Virus Type 1 Positive Adults (TANGO) Switch Study to Evaluate Dolutegravir Plus Lamivudine in Virologically Suppressed Human Immunodeficiency Virus Type 1 Positive Adults (TANGO) - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save

2018 Clinical Trials

18. A chart review of human immunodeficiency virus status in patients admitted with psychosis in Durban, South Africa Full Text available with Trip Pro

A chart review of human immunodeficiency virus status in patients admitted with psychosis in Durban, South Africa Comorbid human immunodeficiency virus (HIV) infection among patients with psychotic disorders is associated with a poorer outcome. Understanding the association of HIV infection with demographic and clinical variables may provide clues to modify risk factors and outcomes.To describe and compare the socio-demographic and clinical profile of patients admitted with psychotic disorders (...) with and without HIV infection.A retrospective chart review of 100 adult patients consecutively admitted with psychosis and HIV infection and compared to 101 patients with psychosis without HIV infection.HIV-infected patients with psychotic disorders were more likely to be females (74.0%), younger than 50 years (94.0%) and less likely to have secondary education than HIV- negative patients with psychotic disorders (56.0% vs. 72.0%). HIV-infected patients were also less likely to be diagnosed as having

2018 The South African journal of psychiatry : SAJP : the journal of the Society of Psychiatrists of South Africa

19. Sexual risk during pregnancy and postpartum periods among HIV-infected and -uninfected South African women: Implications for primary and secondary HIV prevention interventions. Full Text available with Trip Pro

Sexual risk during pregnancy and postpartum periods among HIV-infected and -uninfected South African women: Implications for primary and secondary HIV prevention interventions. HIV acquisition in pregnancy and breastfeeding contributes significantly toward pediatric HIV infection. However, little is known about how sexual behavior changes during pregnancy and postpartum periods which will help develop targeted HIV prevention and transmission interventions, including pre-exposure prophylaxis (...) had increased odds of reporting condomless sex at last sex (aOR = 2.96;95%CI = 1.84-4.78) and ever having condomless sex in past 3-months (aOR = 2.65;95%CI = 1.30-5.44) adjusting for age, HIV status, and sex frequency compared to postpartum women.We identified that sexual behaviors and risk behaviors were high and changing during pregnancy and postpartum periods, presenting challenges to primary and secondary HIV prevention efforts, including PrEP delivery to pregnant and breastfeeding women.

2018 PLoS ONE

20. National Multicenter Trial Evaluating Two Treatments in Patients With Primary Human Immunodeficiency Virus (HIV-1) Infection

National Multicenter Trial Evaluating Two Treatments in Patients With Primary Human Immunodeficiency Virus (HIV-1) Infection National Multicenter Trial Evaluating Two Treatments in Patients With Primary Human Immunodeficiency Virus (HIV-1) Infection - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached (...) the maximum number of saved studies (100). Please remove one or more studies before adding more. National Multicenter Trial Evaluating Two Treatments in Patients With Primary Human Immunodeficiency Virus (HIV-1) Infection (OPTIPRIM-2) The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our for details. ClinicalTrials.gov Identifier: NCT02987530 Recruitment

2016 Clinical Trials

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