A pilot, prospective, open-label simplification study to evaluate the safety, efficacy, and pharmacokinetics of once-daily lopinavir-ritonavir monotherapy in HIV-HCV coinfected patients: the MONOCO study.

Abstract:

BACKGROUND:A safe, effective, easy-to-dose antiretroviral therapy that minimizes hepatic complication risk is essential in optimizing HIV-HCV treatment. Nucleoside-sparing boosted protease inhibitor monotherapy may achieve this goal. METHODS:A prospective, open-label pilot simplification study of once-daily lopinavir/ritonavir (LPV/r) monotherapy in HIV-HCV coinfected patients was conducted in patients on HAART with undetectable HIV RNA for ≥6 months. The primary outcome was maintenance of HIV RNA<50 copies/mL through week 48. HIV RNA, immune measures, metabolic markers, and pharmacokinetics were assessed. RESULTS:Twenty participants received once-daily LPV/r monotherapy. Mean baseline age was 46.9 years and CD4 467 cells/L. By per protocol analysis, 71.4% (95% CI, 45.4-88.3) remained on once-daily LPV/r monotherapy with virologic suppression at week 48. Virologic breakthrough (HIV RNA>50 copies/mL on 2 consecutive measures) occurred in 7 patients (mean standard error [SE] time to breakthrough, 38.3 [4.8] weeks). Resuppression occurred with improved adherence in 2 participants and improved adherence plus addition of nucleosides in 2 others. LPV C min was <1 mg/L in 8 patients and was associated with virologic breakthrough in 2 cases but with no development of resistance. No clinically significant changes in CD4, lipids, or glucose were noted. Three participants developed transient≥5-fold liver enzyme elevations. None of 9 severe adverse events were LPV/r- or liver-related. Six discontinued participation for withdrawal of consent (n=1), poor adherence (n=3), or drug intolerance (n=2). CONCLUSIONS:Once-daily LPV/r monotherapy in HIV-HCV coinfected individuals offers a safe and effective approach to the management of the HIV infection, with a predictable pharmacokinetic profile.

journal_name

HIV Clin Trials

journal_title

HIV clinical trials

authors

Cooper C,la Porte C,Tossonian H,Sampalis J,Ackad N,Conway B

doi

10.1310/hct1304-179

subject

Has Abstract

pub_date

2012-07-01 00:00:00

pages

179-88

issue

4

eissn

1528-4336

issn

1945-5771

pii

E0375654W3K11225

journal_volume

13

pub_type

临床试验,杂志文章
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    更新日期:2015-03-01 00:00:00

  • Improved survival in HIV-associated diffuse large B-cell lymphoma with the addition of rituximab to chemotherapy in patients receiving highly active antiretroviral therapy.

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    doi:10.1310/hct0803-132

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    更新日期:2007-05-01 00:00:00

  • Database-supported teleconferencing: an additional clinical mentoring tool to assist a multinational company HIV/AIDS treatment program in Africa.

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    journal_title:HIV clinical trials

    pub_type: 杂志文章

    doi:10.1310/hct0705-255

    authors: Clevenbergh P,Van der Borght SF,van Cranenburgh K,Janssens V,Kitenge Lubangi C,Gahimbaza L,Lange JM,Rinke de Wit TF,Rijckborst H

    更新日期:2006-09-01 00:00:00

  • Salvage therapy with amprenavir and ritonavir: prospective study in 17 heavily pretreated patients.

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    pub_type: 临床试验,杂志文章

    doi:10.1310/RFT5-7N0M-8C5G-0TL2

    authors: Arvieux C,Tattevin P,Souala FM,Jaccard P,Ruffault A,Bentué-Ferrer D,Tribut O,Chapplain JM,Dupont M,Bouvier C,Michelet C

    更新日期:2002-03-01 00:00:00

  • Serious renal impairment occurs rarely with use of tenofovir DF.

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    journal_title:HIV clinical trials

    pub_type: 杂志文章,多中心研究

    doi:10.1310/2taj-qpd1-tyae-qak5

    authors: Scott JD,Wolfe PR,Bolan RK,Guyer B

    更新日期:2006-03-01 00:00:00

  • Granulocyte-macrophage colony-stimulating factor (GM-CSF) restores allostimulatory function to accessory cells in patients with AIDS.

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    journal_title:HIV clinical trials

    pub_type: 临床试验,杂志文章

    doi:10.1310/HP8B-NF27-VFWA-80YX

    authors: Bernstein ZP,Brooks SP,Chanan-Khan A,Gollnick SO,Gilbert MJ,Miller KC,Tomasi TB

    更新日期:2002-05-01 00:00:00

  • Evolution of genotypic resistance algorithms and their impact on the interpretation of clinical trials: an OPTIMA trial substudy.

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    journal_title:HIV clinical trials

    pub_type: 杂志文章

    doi:10.1310/hct0805-293

    authors: Desai S,Kyriakides T,Holodniy M,Al-Salman J,Griffith B,Kozal M

    更新日期:2007-09-01 00:00:00

  • Darier disease associated with HIV infection: a case report.

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    journal_title:HIV clinical trials

    pub_type: 杂志文章

    doi:10.1310/hct1201-48

    authors: Emadi SN,Izadi M,Poursaleh Z,Akhavan-Moghaddam J,Barikbin B,Emadi SE

    更新日期:2011-01-01 00:00:00

  • Long-term outcome of HIV-infected patients with multinucleoside-resistant genotypes.

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    journal_title:HIV clinical trials

    pub_type: 杂志文章

    doi:10.1310/X618-KWKJ-WCTQ-LQ2L

    authors: Gallego O,d Mendoza C,Labarga P,Altisent C,González J,García-Alcalde I,Valer L,Valencia E,Soriano V

    更新日期:2003-11-01 00:00:00

  • Protease-sparing regimen in a real-life practice with naïve patients: an equal opportunity approach?

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    journal_title:HIV clinical trials

    pub_type: 临床试验,杂志文章

    doi:10.1310/2V0B-HDWC-AGWR-H56M

    authors: Corales RB,Shrestha NK,Taege AJ,Isada CM,Rehm SJ,Schmitt SK,Gordon SM,Mawhorter SD

    更新日期:2001-01-01 00:00:00

  • HIV production from purified monocytes isolated from antiretroviral-naïve and protease inhibitor-treated HIV-1-infected patients.

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    journal_title:HIV clinical trials

    pub_type: 杂志文章

    doi:10.1310/EF26-V3PC-AG5X-FCF4

    authors: Kazanjian P,Adams D,Tate S,Newman G

    更新日期:2002-11-01 00:00:00

  • Resistance to antiretroviral agents in individuals with HIV-1 non-B subtypes.

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    journal_title:HIV clinical trials

    pub_type: 杂志文章,评审

    doi:10.1310/7bwp-0x7f-nxna-qrnp

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  • Lipid profile during pregnancy in HIV-infected women.

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    pub_type: 杂志文章

    doi:10.1310/hct0704-184

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    更新日期:2006-07-01 00:00:00

  • Tuberculosis and HIV infection: epidemiology, immunology, and treatment.

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    journal_title:HIV clinical trials

    pub_type: 杂志文章,评审

    doi:10.1310/TUNH-UAKU-N0E4-1PXF

    authors: Schluger NW,Burzynski J

    更新日期:2001-07-01 00:00:00

  • A meta-analysis of six placebo-controlled trials of thiazolidinedione therapy for HIV lipoatrophy.

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    journal_title:HIV clinical trials

    pub_type: 杂志文章,meta分析

    doi:10.1310/hct1101-39

    authors: Raboud JM,Diong C,Carr A,Grinspoon S,Mulligan K,Sutinen J,Rozenbaum W,Cavalcanti RB,Wand H,Costagliola D,Walmsley S,Glitazone and Lipoatrophy Meta-Analysis Working Group.

    更新日期:2010-01-01 00:00:00

  • Antiretroviral treatment regimen outcomes among HIV-infected prisoners.

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    journal_title:HIV clinical trials

    pub_type: 杂志文章

    doi:10.1310/hct0804-205

    authors: Springer SA,Friedland GH,Doros G,Pesanti E,Altice FL

    更新日期:2007-07-01 00:00:00

  • Clinically stable treatment-experienced adults receiving tenofovir and didanosine.

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    journal_title:HIV clinical trials

    pub_type: 临床试验,杂志文章

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    authors: Di Biagio A,Beltrame A,Cenderello G,Ferrea G,De Maria A

    更新日期:2006-01-01 00:00:00

  • The insufficient suppression of viral load by saquinavir hard gel is reversible: a retrospective cohort study.

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    journal_title:HIV clinical trials

    pub_type: 临床试验,杂志文章

    doi:10.1310/KED4-8TW3-4ARG-HFC5

    authors: Jensen-Fangel S,Kirk O,Blaxhult A,Gerstoft J,Pedersen C,Black FT,Lundgren JD,Obel N

    更新日期:2001-03-01 00:00:00

  • Tenofovir/emtricitabine/efavirenz plus rosuvastatin decrease serum levels of inflammatory markers more than antiretroviral drugs alone in antiretroviral therapy-naive HIV-infected patients.

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    journal_title:HIV clinical trials

    pub_type: 杂志文章

    doi:10.1310/hct1501-1

    authors: Calza L,Vanino E,Salvadori C,Manfredi R,Colangeli V,Cascavilla A,Di Bari MA,Motta R,Viale P

    更新日期:2014-01-01 00:00:00

  • Site nurse-initiated adherence and symptom support telephone calls for HIV-positive individuals starting antiretroviral therapy, ACTG 5031: substudy of ACTG 384.

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    journal_title:HIV clinical trials

    pub_type: 杂志文章,随机对照试验

    doi:10.1310/hct1405-235

    authors: Robbins GK,Testa MA,Su M,Safren SA,Morse G,Lammert S,Shafer RW,Reynolds NR,Chesney MA

    更新日期:2013-09-01 00:00:00

  • Can Probiotics Reduce Inflammation and Enhance Gut Immune Health in People Living with HIV: Study Designs for the Probiotic Visbiome for Inflammation and Translocation (PROOV IT) Pilot Trials.

    abstract:OBJECTIVES:Despite substantial improvements in HIV outcomes with combination antiretroviral therapy (cART), morbidity and mortality remain above population norms. The gut mucosal immune system is not completely restored by cART, and the resultant microbial translocation may contribute to chronic inflammation, inadequat...

    journal_title:HIV clinical trials

    pub_type: 临床试验,杂志文章,多中心研究,随机对照试验

    doi:10.1080/15284336.2016.1184827

    authors: Kim CJ,Walmsley SL,Raboud JM,Kovacs C,Coburn B,Rousseau R,Reinhard R,Rosenes R,Kaul R

    更新日期:2016-07-01 00:00:00

  • Maximizing participant retention in a phase 2B HIV prevention trial in Kampala, Uganda: The MTN-003 (VOICE) Study.

    abstract:BACKGROUND:The success of longitudinal trials depends greatly on using effective strategies to retain participants and ensure internal validity, maintain sufficient statistical power, and provide for the generalizability of study results. OBJECTIVE:This paper describes the challenges and specific strategies used to re...

    journal_title:HIV clinical trials

    pub_type: 杂志文章,多中心研究,随机对照试验

    doi:10.1080/15284336.2018.1513711

    authors: Wynne J,Muwawu R,Mubiru MC,Kamira B,Kemigisha D,Nakyanzi T,Kabwigu S,Nakabiito C,Kiweewa Matovu F

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  • Randomized, placebo-controlled trial of product R, a peptide-nucleic acid immunomodulator, in the treatment of adults infected with HIV.

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    journal_title:HIV clinical trials

    pub_type: 临床试验,杂志文章,随机对照试验

    doi:10.1310/N34A-653T-ABF5-8Q1R

    authors: Levett PN,Hirschman SZ,Roach TC,Broome H,Alexander RJ,Fraser HS

    更新日期:2002-07-01 00:00:00

  • Sustained efficacy of nevirapine in combination with two nucleoside analogues in the treatment of HIV-infected patients: a 48-week retrospective multicenter study.

    abstract:BACKGROUND:Nevirapine, a nonnucleoside analogue, has demonstrated suppression of human immunodeficiency virus (HIV) replication alone and in combination therapy. However, the durable suppression of HIV with nevirapine when used along with other nucleosides in HIV-infected patients who are treated in clinical practice n...

    journal_title:HIV clinical trials

    pub_type: 杂志文章,多中心研究

    doi:10.1310/4nb4-1gx6-4xvk-pbgl

    authors: Allan PS,Arumainayagam J,Harindra V,Tobin J,Browning M,Yoganathan K,Wade A,Das S

    更新日期:2003-07-01 00:00:00

  • Pharmacokinetic characterization of different dose combinations of coadministered tipranavir and ritonavir in healthy volunteers.

    abstract:PURPOSE:To characterize the steady-state pharmacokinetic combination of the nonpeptidic protease inhibitor tipranavir (TPV) with ritonavir (RTV) in 95 healthy adult volunteers, a phase 1, single-center, open-label, randomized, parallel-group trial was conducted. METHOD:Participants received 250-mg self-emulsifying dru...

    journal_title:HIV clinical trials

    pub_type: 临床试验,杂志文章,随机对照试验

    doi:10.1310/RRX7-49ME-27V7-MWWV

    authors: MacGregor TR,Sabo JP,Norris SH,Johnson P,Galitz L,McCallister S

    更新日期:2004-11-01 00:00:00

  • Rilpivirine versus efavirenz in HIV-1-infected subjects receiving emtricitabine/tenofovir DF: pooled 96-week data from ECHO and THRIVE Studies.

    abstract:OBJECTIVES:Week 96 efficacy and safety of the non-nucleoside reverse transcriptase inhibitor (NNRTI) rilpivirine (RPV) was compared to efavirenz (EFV) in subset of 1,096 subjects who received emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) in pooled data from 2 phase 3 studies. METHODS:ECHO and THRIVE are double...

    journal_title:HIV clinical trials

    pub_type: 杂志文章,随机对照试验

    doi:10.1310/hct1403-81

    authors: Nelson MR,Elion RA,Cohen CJ,Mills A,Hodder SL,Segal-Maurer S,Bloch M,Garner W,Guyer B,Williams S,Chuck S,Vanveggel S,Deckx H,Stevens M

    更新日期:2013-05-01 00:00:00

  • Efficacy of an educational and counseling intervention on adherence to highly active antiretroviral therapy: French prospective controlled study.

    abstract:PURPOSE:The objective was to evaluate the impact of an intervention for improving adherence to antiretroviral therapies (HAART) in HIV-infected patients. METHOD:We designed a prospective, controlled, randomized trial to assess the impact of an educational and counseling intervention in addition to standard of care. At...

    journal_title:HIV clinical trials

    pub_type: 临床试验,杂志文章,随机对照试验

    doi:10.1310/brbv-3941-h1pp-ndry

    authors: Pradier C,Bentz L,Spire B,Tourette-Turgis C,Morin M,Souville M,Rebillon M,Fuzibet JG,Pesce A,Dellamonica P,Moatti JP

    更新日期:2003-03-01 00:00:00

  • Monthly unannounced pill counts for monitoring HIV treatment adherence: tests for self-monitoring and reactivity effects.

    abstract:BACKGROUND:Unannounced home-based pill counts conducted in person or on the telephone are reliable and valid for monitoring medication adherence. However, expecting to have one's pills counted, organizing medications for pill counts, and increased attention from the person conducting the pill counts may have reactive e...

    journal_title:HIV clinical trials

    pub_type: 临床试验,杂志文章

    doi:10.1310/hct1106-325

    authors: Kalichman SC,Amaral C,Swetsze C,Eaton L,Kalichman MO,Cherry C,Detorio M,Caliendo AM,Schinazi RF

    更新日期:2010-11-01 00:00:00

  • Relationship between low bone mineral density and highly active antiretroviral therapy including protease inhibitors in HIV-infected patients.

    abstract:PURPOSE:The objectives of this study were to determine the prevalence of osteopenia and the factors associated with its presence in HIV-infected patients under highly active antiretroviral therapy (HAART) and to assess the changes of bone mineral density (BMD) in a population followed prospectively. METHOD:BMD was ass...

    journal_title:HIV clinical trials

    pub_type: 杂志文章

    doi:10.1310/4X0H-UVMJ-BHYW-CPFB

    authors: Fernández-Rivera J,García R,Lozano F,Macías J,García-García JA,Mira JA,Corzo JE,Gómez-Mateos J,Rueda A,Sánchez-Burson J,Pineda JA

    更新日期:2003-09-01 00:00:00

  • Effect of baseline characteristics on the efficacy and safety of once-daily darunavir/ ritonavir in HIV-1-infected, treatment-naïve ARTEMIS patients at week 96.

    abstract:OBJECTIVES:ARTEMIS demonstrated significantly greater efficacy of once-daily darunavir/ritonavir (DRV/r) 800/100 mg versus lopinavir/ritonavir 800/200 mg (total daily dose) in treatment-naïve, HIV-1-infected patients at week 96. The influence of baseline characteristics on efficacy and safety was analyzed in DRV/r pati...

    journal_title:HIV clinical trials

    pub_type: 杂志文章,随机对照试验

    doi:10.1310/hct1206-313

    authors: Fourie J,Flamm J,Rodriguez-French A,Kilby D,Domingo P,Lazzarin A,Ballesteros J,Sosa N,Van De Casteele T,DeMasi R,Spinosa-Guzman S,Lavreys L

    更新日期:2011-11-01 00:00:00