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 Trialsjournal_title
HIV clinical trialsauthors
Cooper C,la Porte C,Tossonian H,Sampalis J,Ackad N,Conway Bdoi
10.1310/hct1304-179subject
Has Abstractpub_date
2012-07-01 00:00:00pages
179-88issue
4eissn
1528-4336issn
1945-5771pii
E0375654W3K11225journal_volume
13pub_type
临床试验,杂志文章abstract:BACKGROUND:Perinatally acquired HIV-infected (PaHIV) young adults undergo neurodevelopment in the presence of HIV infection and antiretroviral therapy, which may lead to neurocognitive (NC) impairment. Knowledge of NC function in this group is sparse and control data lacking. We compared cerebral function in young adul...
journal_title:HIV clinical trials
pub_type: 杂志文章
doi:10.1179/1528433614Z.0000000003
更新日期:2015-03-01 00:00:00
abstract:PURPOSE:Recent trials suggest serious toxicity in HIV-associated non-Hodgkin's lymphoma (NHL) with rituximab (R) and chemotherapy (CT), offsetting the benefit of rituximab. METHOD:We retrospectively reviewed experience with CHOP-R vs. CT in 40 patients with HIV-associated diffuse large B-cell lymphoma (DLBCL) diagnose...
journal_title:HIV clinical trials
pub_type: 杂志文章
doi:10.1310/hct0803-132
更新日期:2007-05-01 00:00:00
abstract:BACKGROUND:The lack of human resources for health is presently recognized as a major factor limiting scale-up of antiretroviral treatment (ART) programs in resourcelimited settings. The mobilization of public and private partners, the decentralization of care, and the training of non-HIV specialist nurses and general p...
journal_title:HIV clinical trials
pub_type: 杂志文章
doi:10.1310/hct0705-255
更新日期:2006-09-01 00:00:00
abstract:OBJECTIVE:To evaluate the safety profile and efficacy of salvage regimens containing amprenavir (APV) 600 mg twice daily and ritonavir (RTV) 200 mg twice daily. DESIGN:Prospective, single-center study. METHOD:The patient database of the department of infectious diseases was screened for patients who had failed at lea...
journal_title:HIV clinical trials
pub_type: 临床试验,杂志文章
doi:10.1310/RFT5-7N0M-8C5G-0TL2
更新日期:2002-03-01 00:00:00
abstract:PURPOSE:The purpose of this study was to evaluate the short-term effects (up to 6 months) of tenofovir disoproxil fumarate (DF) use on renal function in patients being treated for HIV-1 infection. METHOD:The charts of 447 HIV-1-infected patients who received at least three months of tenofovir DF treatment were reviewe...
journal_title:HIV clinical trials
pub_type: 杂志文章,多中心研究
doi:10.1310/2taj-qpd1-tyae-qak5
更新日期:2006-03-01 00:00:00
abstract:BACKGROUND:Impaired allostimulatory function of dendritic cells in patients with AIDS has been reported previously. Granulocyte-macrophage colony-stimulating factor (GM-CSF) can restore the T-cell stimulatory function in transforming growth factor-beta 1 (TGF-beta 1)-inhibited murine accessory cells. We now report the ...
journal_title:HIV clinical trials
pub_type: 临床试验,杂志文章
doi:10.1310/HP8B-NF27-VFWA-80YX
更新日期:2002-05-01 00:00:00
abstract:PURPOSE:The outdated rules of older HIV genotypic resistance algorithms can affect virologic responses. This study was designed to determine how often these incorrect resistance interpretations affect analyses of long-term clinical trials, antiretroviral (ARV) choices, and HIV disease progression rates. METHOD:Baselin...
journal_title:HIV clinical trials
pub_type: 杂志文章
doi:10.1310/hct0805-293
更新日期:2007-09-01 00:00:00
abstract::AIDS is characterized with immune dysregulation and depletion of CD4+ T cells and increased vulnerability to different pathological conditions, including many dermatoses. The present report describes features of Darier disease (DD) in an HIV-positive patient. The subject of this report was a 45-year old Ghanaian man r...
journal_title:HIV clinical trials
pub_type: 杂志文章
doi:10.1310/hct1201-48
更新日期:2011-01-01 00:00:00
abstract:BACKGROUND:Multiple resistance to nucleoside analogs mediated by the Q151M complex and/or codon 67-69 inserts/deletions represents a growing problem among HIV-infected persons, most of whom have been exposed to sequential therapies for long periods of time. PATIENTS AND METHOD:All plasma samples collected from HIV-inf...
journal_title:HIV clinical trials
pub_type: 杂志文章
doi:10.1310/X618-KWKJ-WCTQ-LQ2L
更新日期:2003-11-01 00:00:00
abstract:PURPOSE:Proven clinical efficacy of protease-sparing regimens (PSR) has been shown. Concerns exist about broad applicability of these regimens in advanced naïve patients. Recent reports have associated a rise in liver enzymes with nevi rapine; however, no data exist with efavirenz. METHOD:17 consecutive antiretroviral...
journal_title:HIV clinical trials
pub_type: 临床试验,杂志文章
doi:10.1310/2V0B-HDWC-AGWR-H56M
更新日期:2001-01-01 00:00:00
abstract:PURPOSE:We obtained peripheral blood monocytes from HIV-1-infected patients and differentiated them into macrophages in vitro to investigate the contribution of purified monocytes to plasma viremia in HIV-infected patients. METHOD:We compared the production of HIV-1 from purified monocytes isolated from patients who w...
journal_title:HIV clinical trials
pub_type: 杂志文章
doi:10.1310/EF26-V3PC-AG5X-FCF4
更新日期:2002-11-01 00:00:00
abstract::Naturally occurring polymorphisms at positions involved in resistance to antiretroviral agents are frequently seen in HIV-1 non-B subtypes. Although they do not seem to affect significantly the susceptibility to antiretroviral drugs in vitro, they may facilitate the selection of different pathways and/or a more rapid ...
journal_title:HIV clinical trials
pub_type: 杂志文章,评审
doi:10.1310/7bwp-0x7f-nxna-qrnp
更新日期:2002-09-01 00:00:00
abstract:PURPOSE:We investigated the evolution of serum lipid levels in HIV-infected pregnant women and the potential effect of antiretroviral treatment during pregnancy using data from a national surveillance study. METHOD:Fasting lipid measurements collected during routine care in pregnancy were used, analyzing longitudinal ...
journal_title:HIV clinical trials
pub_type: 杂志文章
doi:10.1310/hct0704-184
更新日期:2006-07-01 00:00:00
abstract::Tuberculosis and HIV have combined to present a major threat to global public health. Each disease has a negative effect on the other, and mortality in patients with both tuberculosis and HIV is higher than that caused by either condition alone. In regions such as sub-Saharan Africa, as many as a third or more of all ...
journal_title:HIV clinical trials
pub_type: 杂志文章,评审
doi:10.1310/TUNH-UAKU-N0E4-1PXF
更新日期:2001-07-01 00:00:00
abstract:OBJECTIVE:To determine the impact of thiazolidinediones (TZD) on changes in limb fat mass in HIV-infected individuals, particularly in those not receiving a thymidine analogue. METHODS:Individual patient data from placebo-controlled, randomized trials of rosiglitazone (n = 5) or pioglitazone (n = 1) were combined. Gen...
journal_title:HIV clinical trials
pub_type: 杂志文章,meta分析
doi:10.1310/hct1101-39
更新日期:2010-01-01 00:00:00
abstract:BACKGROUND:Despite the high prevalence of HIV in correctional settings, the duration of therapy and response to various highly active antiretroviral therapy (HAART) regimens in this setting is unknown. METHOD:Using a retrospective cohort study (1997-2002) of HIV-infected prisoners in Connecticut that linked demographi...
journal_title:HIV clinical trials
pub_type: 杂志文章
doi:10.1310/hct0804-205
更新日期:2007-07-01 00:00:00
abstract:METHOD:Analysis of virological, immunological, and clinical data over 24 weeks of treatment of drug-experienced patients administered didanosine (ddI) and tenofovir (TDF) plus either PI or NNRTI (17 patients) compared to 14 patients on ddI plus lamivudine and to 19 patients on ddI plus stavudine. RESULTS:Patients trea...
journal_title:HIV clinical trials
pub_type: 临床试验,杂志文章
doi:10.1310/0B0R-J1LP-KQPF-43HB
更新日期:2006-01-01 00:00:00
abstract:PURPOSE:To assess the effect of changing antiretroviral therapy in patients initially treated with saquinavir hard gel capsule (hgc). METHOD:A retrospective cohort study comparing the virological and immunological responses in antiretroviral-naïve patients initially treated with a regimen of saquinavir-hgc, zidovudine...
journal_title:HIV clinical trials
pub_type: 临床试验,杂志文章
doi:10.1310/KED4-8TW3-4ARG-HFC5
更新日期:2001-03-01 00:00:00
abstract:OBJECTIVES:Statins are lipid-lowering drugs that exhibit anti-Inflammatory and immune-modulatory properties, leading to a reduction of serum levels of C-reactive protein (CRP) in the general population. DESIGN:To assess the anti-inflammatory effects of statins in HIV-infected patients, because very limited data are av...
journal_title:HIV clinical trials
pub_type: 杂志文章
doi:10.1310/hct1501-1
更新日期:2014-01-01 00:00:00
abstract:BACKGROUND:Effective and easy to implement interventions to improve adherence to antiretroviral therapy are needed. OBJECTIVE:To compare site nurse-initiated adherence and symptom support telephone calls for HIV-positive individuals starting antiretroviral therapy to the study site's standard of care. METHODS:A rando...
journal_title:HIV clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1310/hct1405-235
更新日期:2013-09-01 00:00:00
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
更新日期:2016-07-01 00:00:00
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
更新日期:2018-10-01 00:00:00
abstract:OBJECTIVE:The efficacy of Product R, a nontoxic peptide-nucleic acid, was tested in 43 HIV-infected adults naïve to antiretroviral therapy. METHOD:Patients were randomized to receive Product R (21 patients) or placebo (22 patients). Dosage was two 1 mL subcutaneous injections daily on days 1-14, followed by 1 mL daily...
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
更新日期:2002-07-01 00:00:00
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
更新日期:2003-07-01 00:00:00
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
更新日期:2004-11-01 00:00:00
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
更新日期:2013-05-01 00:00:00
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
更新日期:2003-03-01 00:00:00
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
更新日期:2010-11-01 00:00:00
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
更新日期:2003-09-01 00:00:00
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
更新日期:2011-11-01 00:00:00