Methodological issues in the use of composite endpoints in clinical trials: examples from the HIV field (Q37692734)

22 August 2017

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title

Methodological issues in the use of composite endpoints in clinical trials: examples from the HIV field (English)

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22 August 2017

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4

Caroline Sabin

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Linda Wittkop

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Linda Wittkop

1

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Rodolphe Thiébaut

10

object named as

Rodolphe Thiébaut

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22 August 2017

7

Andrew Phillips

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22 August 2017

8

Genevieve Chêne

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22 August 2017

Colette Smith

2

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22 August 2017

Zoe Fox

3

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22 August 2017

Laura Richert

5

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22 August 2017

Jean-Pierre Aboulker

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22 August 2017

Abdel Babiker

9

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22 August 2017

NEAT-WP4

11

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22 August 2017

1 February 2010

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22 August 2017

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22 August 2017

7

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22 August 2017

19-35

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22 August 2017

1

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British HIV Association guidelines for the treatment of HIV-1-infected adults with antiretroviral therapy 2008

22 August 2017

1 reference

https://api.crossref.org/works/10.1177%2F1740774509356117

Antiretroviral treatment of adult HIV infection: 2008 recommendations of the International AIDS Society-USA panel

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1740774509356117

Correlates of lending needles/syringes among HIV-seropositive injection drug users

21 January 2018

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https://api.crossref.org/works/10.1177%2F1740774509356117

Non-AIDS-defining deaths and immunodeficiency in the era of combination antiretroviral therapy

21 January 2018

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https://api.crossref.org/works/10.1177%2F1740774509356117

The KLEAN study of fosamprenavir-ritonavir versus lopinavir-ritonavir, each in combination with abacavir-lamivudine, for initial treatment of HIV infection over 48 weeks: a randomised non-inferiority trial

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1740774509356117

A randomized trial of the angiotensin-receptor blocker valsartan in chronic heart failure

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1740774509356117

Methodologic discussions for using and interpreting composite endpoints are limited, but still identify major concerns

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1740774509356117

Validity of composite end points in clinical trials

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1740774509356117

Combination of isosorbide dinitrate and hydralazine in blacks with heart failure

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1740774509356117

Three- vs four-drug antiretroviral regimens for the initial treatment of HIV-1 infection: a randomized controlled trial

21 January 2018

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https://api.crossref.org/works/10.1177%2F1740774509356117

Virologic and regimen termination surrogate end points in AIDS clinical trials

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1740774509356117

Treatment with amprenavir alone or amprenavir with zidovudine and lamivudine in adults with human immunodeficiency virus infection. AIDS Clinical Trials Group 347 Study Team.

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1740774509356117

Class-sparing regimens for initial treatment of HIV-1 infection

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1740774509356117

Design and analysis of clinical trials with a bivariate failure time endpoint, with application to AIDS Clinical Trials Group Study A5142

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1740774509356117

Methods of correcting for multiple testing: operating characteristics

21 January 2018

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https://api.crossref.org/works/10.1177%2F1740774509356117

On closed testing procedures with special reference to ordered analysis of variance

21 January 2018

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https://api.crossref.org/works/10.1177%2F1740774509356117

Drug development strategies for salvage therapy: conflicts and solutions

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1740774509356117

Drug switching and virologic-based endpoints in trials of antiretroviral drugs for HIV infection.

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1740774509356117

Abacavir-lamivudine-zidovudine vs indinavir-lamivudine-zidovudine in antiretroviral-naive HIV-infected adults: A randomized equivalence trial

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1740774509356117

Continued indinavir versus switching to indinavir/ritonavir in HIV-infected patients with suppressed viral load

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1740774509356117

Intention-to-treat vs. on-treatment analyses of clinical trial data: experience from a study of pyrimethamine in the primary prophylaxis of toxoplasmosis in HIV-infected patients. ANRS 005/ACTG 154 Trial Group.

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1740774509356117

Trials to assess equivalence: the importance of rigorous methods

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1740774509356117

Reporting of noninferiority and equivalence randomized trials: an extension of the CONSORT statement

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1740774509356117

Designing and interpreting HIV noninferiority trials in naive and experienced patients

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1740774509356117

Problems with use of composite end points in cardiovascular trials: systematic review of randomised controlled trials

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1740774509356117

Composite outcomes in cardiovascular research: a survey of randomized trials

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1740774509356117

Efficacy and safety of emtricitabine vs stavudine in combination therapy in antiretroviral-naive patients: a randomized trial

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1740774509356117

Randomized, double-blind comparison of two nelfinavir doses plus nucleosides in HIV-infected patients (Agouron study 511).

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1740774509356117

A practical approach to adjusting for attrition bias in HIV clinical trials with serial marker responses

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1740774509356117

Composite outcomes in randomized trials: greater precision but with greater uncertainty?

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1740774509356117

Polychemotherapy for early breast cancer: an overview of the randomised clinical trials with quality-adjusted survival analysis

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1740774509356117

Lopinavir/ritonavir monotherapy or plus zidovudine and lamivudine in antiretroviral-naive HIV-infected patients.

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1740774509356117

Induction therapy with trizivir plus efavirenz or lopinavir/ritonavir followed by trizivir alone in naive HIV-1-infected adults.

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1740774509356117

Efficacy and tolerability of long-term efavirenz plus nucleoside reverse transcriptase inhibitors for HIV-1 infection.

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1740774509356117

Rapid and durable antiretroviral effect of the HIV-1 Integrase inhibitor raltegravir as part of combination therapy in treatment-naive patients with HIV-1 infection: results of a 48-week controlled study

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1740774509356117

Tenofovir DF, emtricitabine, and efavirenz vs. zidovudine, lamivudine, and efavirenz for HIV.

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1740774509356117

Virological and immunological outcomes at 3 years after starting antiretroviral therapy with regimens containing non-nucleoside reverse transcriptase inhibitor, protease inhibitor, or both in INITIO: open-label randomised trial.

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1740774509356117

Induction with abacavir/lamivudine/zidovudine plus efavirenz for 48 weeks followed by 48-week maintenance with abacavir/lamivudine/zidovudine alone in antiretroviral-naive HIV-1-infected patients

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1740774509356117

Efficacy and safety of tenofovir DF vs stavudine in combination therapy in antiretroviral-naive patients: a 3-year randomized trial

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1740774509356117

Comparison of first-line antiretroviral therapy with regimens including nevirapine, efavirenz, or both drugs, plus stavudine and lamivudine: a randomised open-label trial, the 2NN Study

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1740774509356117

Once-daily versus twice-daily lamivudine, in combination with zidovudine and efavirenz, for the treatment of antiretroviral-naive adults with HIV infection: a randomized equivalence trial

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1740774509356117

SOLO: 48-week efficacy and safety comparison of once-daily fosamprenavir /ritonavir versus twice-daily nelfinavir in naive HIV-1-infected patients

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1740774509356117

Abacavir once or twice daily combined with once-daily lamivudine and efavirenz for the treatment of antiretroviral-naive HIV-infected adults: results of the Ziagen Once Daily in Antiretroviral Combination Study.

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1740774509356117

Comparison of two once-daily regimens with a regimen consisting of nelfinavir, didanosine, and stavudine in antiretroviral therapy-naïve adults: 48-week results from the Antiretroviral Regimen Evaluation Study (ARES).

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1740774509356117

A randomized trial comparing the efficacy and tolerability of two HAART strategies at two years in antiretroviral naive patients.

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1740774509356117

Lopinavir-ritonavir monotherapy versus lopinavir-ritonavir and two nucleosides for maintenance therapy of HIV.

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1740774509356117

Durable efficacy of tipranavir-ritonavir in combination with an optimised background regimen of antiretroviral drugs for treatment-experienced HIV-1-infected patients at 48 weeks in the Randomized Evaluation of Strategic Intervention in multi-drug r

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1740774509356117

Efficacy and safety of TMC125 (etravirine) in treatment-experienced HIV-1-infected patients in DUET-2: 24-week results from a randomised, double-blind, placebo-controlled trial.

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1740774509356117

Efficacy and safety of darunavir-ritonavir at week 48 in treatment-experienced patients with HIV-1 infection in POWER 1 and 2: a pooled subgroup analysis of data from two randomised trials

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1740774509356117

Atazanavir plus ritonavir or saquinavir, and lopinavir/ritonavir in patients experiencing multiple virological failures

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1740774509356117

Long-term efficacy and safety of tipranavir boosted with ritonavir in HIV-1-infected patients failing multiple protease inhibitor regimens: 80-week data from a phase 2 study

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1740774509356117

Durable efficacy of enfuvirtide over 48 weeks in heavily treatment-experienced HIV-1-infected patients in the T-20 versus optimized background regimen only 1 and 2 clinical trials

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1740774509356117

Efficacy and safety of darunavir-ritonavir compared with that of lopinavir-ritonavir at 48 weeks in treatment-experienced, HIV-infected patients in TITAN: a randomised controlled phase III trial

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1740774509356117

Efficacy and safety of TMC125 (etravirine) in treatment-experienced HIV-1-infected patients in DUET-1: 24-week results from a randomised, double-blind, placebo-controlled trial.

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1740774509356117

Randomized controlled trial of once-daily tenofovir, lamivudine, and lopinavir/ritonavir versus remaining on the same regimen in virologically suppressed HIV-infected patients on their first PI-containing HAART regimen.

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1740774509356117

Efficacy and safety of atazanavir-based highly active antiretroviral therapy in patients with virologic suppression switched from a stable, boosted or unboosted protease inhibitor treatment regimen: the SWAN Study (AI424-097) 48-week results

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1740774509356117

Safety and efficacy of the HIV-1 integrase inhibitor raltegravir (MK-0518) in treatment-experienced patients with multidrug-resistant virus: a phase II randomised controlled trial

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1740774509356117

Intensification of a triple-nucleoside regimen with tenofovir or efavirenz in HIV-1-infected patients with virological suppression

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1740774509356117

Efficacy and safety of a once-daily fixed-dose combination of abacavir/lamivudine compared with abacavir twice daily and lamivudine once daily as separate entities in antiretroviral-experienced HIV-1-infected patients (CAL30001 Study).

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1740774509356117

Lopinavir/ritonavir as single-drug therapy for maintenance of HIV-1 viral suppression: 48-week results of a randomized, controlled, open-label, proof-of-concept pilot clinical trial (OK Study).

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1740774509356117

A randomized controlled trial investigating the efficacy and safety of switching from a protease inhibitor to nevirapine in patients with undetectable viral load.

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1740774509356117

Antiretroviral treatment simplification with 3 NRTIs or 2 NRTIs plus nevirapine in HIV-1-infected patients treated with successful first-line HAART.

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1740774509356117

Abacavir, efavirenz, didanosine, with or without hydroxyurea, in HIV-infected adults failing initial nucleoside/protease inhibitor-containing regimens

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1740774509356117

Didanosine in HIV-1-infected patients experiencing failure of antiretroviral therapy: a randomized placebo-controlled trial

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1740774509356117

Efficacy and safety of etravirine (TMC125) in patients with highly resistant HIV-1: primary 24-week analysis

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1740774509356117

21 January 2018

Identifiers

DOI

10.1177/1740774509356117

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22 August 2017

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