Abstract:
OBJECTIVE:To describe baseline and emergent HIV-1 resistance to elvitegravir/ cobicistat/emtricitabine/tenofovir DF (EVG/COBI/FTC/TDF) and ritonavir-boosted atazanavir/emtricitabine/tenofovir DF (ATV+RTV+FTC/TDF) in HIV-1-infected, treatment-naïve subjects through 144 weeks. METHOD:This was a randomized, double-blind, phase 3 study. HIV-1 protease (PR) and reverse transcriptase (RT) were sequenced at screening. Genotypic and phenotypic analyses were performed at virologic failure confirmation and retrospectively at baseline for PR, RT, and integrase (IN) for patients with virologic failure through week 144. RESULTS:In the EVG/ COBI/FTC/TDF group through week 144, HIV-1 from 8 patients (2.3%; 8/353 treated patients) developed primary IN strand transfer inhibitor (INSTI) (n = 6) and/or nucleoside RT inhibitor (NRTI) resistance substitutions (n = 7). The emergence of resistance decreased after the first year, with 5 patients developing HIV-1 resistance through week 48, 1 from weeks 48-96, and 2 from weeks 96-144. Emergent substitutions were E92Q, N155H, or Q148R (n = 2 each) and T66I or T97A (n = 1 each) in IN and M184V/I (n = 7) and K65R (n = 1) in RT. All 8 isolates had reduced susceptibility to EVG, FTC, or TDF. Virus with EVG phenotypic resistance showed cross-resistance to raltegravir. In the ATV+RTV+FTC/TDF group, HIV-1 from 2 patients (0.6%; 2/355 treated patients; both at week 144) developed the resistance substitution M184V/I in RT. CONCLUSIONS:Resistance development to EVG/COBI/FTC/TDF was infrequent (2.3%) through 144 weeks of therapy and decreased over time, consistent with durable efficacy.
journal_name
HIV Clin Trialsjournal_title
HIV clinical trialsauthors
Kulkarni R,Abram ME,McColl DJ,Barnes T,Fordyce MW,Szwarcberg J,Cheng AK,Miller MD,White KLdoi
10.1310/hct1505-218subject
Has Abstractpub_date
2014-09-01 00:00:00pages
218-30issue
5eissn
1528-4336issn
1945-5771pii
0887067552400646journal_volume
15pub_type
杂志文章,随机对照试验abstract:PURPOSE:Selecting the optimal treatment regimen for antiviral-naive patients may be difficult, given the concern about the antiviral activity, the development of drug resistance, and the increase in drug costs. This study evaluates the costs and effectiveness of using lopinavir/ritonavir (LPV/r) vs. nelfinavir (NFV), b...
journal_title:HIV clinical trials
pub_type: 杂志文章
doi:10.1310/WT81-MEM4-5C4L-CHPK
更新日期:2004-09-01 00:00:00
abstract:PURPOSE:To prospectively determine incidence, prevalence, and extent of lipodystrophy (LD) and associated metabolic changes. METHOD:This was a prospective cohort study. Body habitus changes were determined by anthropometrics, photography, and regional dual-energy X-ray absorptiometry (DXA) scan. Metabolic parameters i...
journal_title:HIV clinical trials
pub_type: 杂志文章
doi:10.1310/hct0905-314
更新日期:2008-09-01 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:BACKGROUND:Immune response rates following influenza vaccination are often lower in HIV-infected individuals. Low vitamin D levels were correlated with weak immune response in cancer patients and are known to be lower in HIV-infected patients. METHODS:Diagnostic study to determine immune response against the H1N1v com...
journal_title:HIV clinical trials
pub_type: 杂志文章
doi:10.1310/hct1404-175
更新日期:2013-07-01 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:PURPOSE:Treatment options for HIV-associated lipodystrophy syndrome (HALS) remain limited. The objective of this randomized open-label study was to compare three emerging therapies, rosiglitazone, pravastatin, and growth hormone alone and together, in men and women with HALS. METHOD:Sixty-four subjects received daily ...
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:10.1310/hct0904-254
更新日期:2008-07-01 00:00:00
abstract:PURPOSE:Questionnaires assessing patient-reported outcomes in HIV are either too long or not HIV-specific. Our aim was to develop and validate a simplified HIV patient questionnaire. METHOD:607 HIV patients treated with a combination of antiretroviral (ARV) drugs were enrolled in an observational, longitudinal study. ...
journal_title:HIV clinical trials
pub_type: 杂志文章
doi:10.1310/hct1004-215
更新日期:2009-07-01 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::Total eradication of HIV-1 is not yet achievable, in part because reservoirs of latent HIV-1 can develop within lymphoid tissue, the testes, and the central nervous system (CNS). The presence of HIV-1 in the CNS is clinically significant because of its association with the development of HIV dementia, which occurs in ...
journal_title:HIV clinical trials
pub_type: 杂志文章,评审
doi:10.1310/AW2H-TP5C-NP43-K6BY
更新日期:2006-05-01 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: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::When prescribed appropriately and taken adherently, antiretroviral therapy can consistently and durably suppress HIV replication, potentially translating into years of near normal health for HIV-infected persons. However, presently available antiretrovirals are associated with a cluster of physical and metabolic sympt...
journal_title:HIV clinical trials
pub_type: 杂志文章,评审
doi:10.1310/XP75-7VJ5-HML2-YF1W
更新日期:2004-05-01 00:00:00
abstract:BACKGROUND:In the HIV Prevention Trials Network (HPTN) 061 study, 8 (2.3%) of 348 HIV-infected participants identified as HIV uninfected at study enrollment using a single HIV rapid test for screening were found to be HIV infected after additional testing. OBJECTIVES:To evaluate the performance of different HIV assays...
journal_title:HIV clinical trials
pub_type: 临床试验,杂志文章
doi:10.1310/hct1502-62
更新日期:2014-03-01 00:00:00
abstract:PURPOSE:A comprehensive study comparing the costs and efficacies of darunavir/ritonavir 800/100 mg qd and the other ritonavir-boosted (/r) protease inhibitors (PIs) recommended for treatment-naïve individuals with HIV-1 infection would help health care decision makers identify the value of each boosted PI. METHODS:A c...
journal_title:HIV clinical trials
pub_type: 杂志文章
doi:10.1310/hct1103-133
更新日期:2010-05-01 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:PURPOSE:Previous studies with intermittent interleukin-2 (IL-2) therapy using intermediate and high levels of IL-2 have demonstrated significant increases in the CD4 + T cell count in HIV-infected patients. Intermittent regimens are amenable to outpatient use, but severe adverse events are frequently experienced with i...
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:10.1310/T5FR-8JPX-0NEF-XDKD
更新日期:2000-11-01 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::This article reports noteworthy HIV/AIDS clinical trials presented at the XVth International AIDS Conference, Bangkok, July 2004, and also outlines goals of comprehensive prevention, care, treatment, and monitoring plans. The Bangkok conference theme was "Access for All." Outlined are goals of comprehensive prevention...
journal_title:HIV clinical trials
pub_type:
doi:10.1310/RM35-RE2A-J9L2-8J47
更新日期:2005-01-01 00:00:00
abstract:PURPOSE:To assess the virologic and immunologic response to a boosted double-protease inhibitor (PI) regimen of highly pretreated patients infected with HIV-1 and to examine the role of PI resistance and concentration of serum saquinavir. METHOD:In an open-label prospective study, lopinavir/ritonavir, saquinavir-sgc, ...
journal_title:HIV clinical trials
pub_type: 临床试验,杂志文章
doi:10.1310/HAG3-8YA5-UDQC-36NX
更新日期:2005-03-01 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 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: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
abstract:OBJECTIVES:Antiretroviral regimen switching may be considered for HIV-1-infected, virologically-suppressed patients to enable treatment simplification or improve tolerability, but should be guided by knowledge of pre-existing drug resistance. The current study examined the impact of pre-existing drug resistance mutatio...
journal_title:HIV clinical trials
pub_type: 临床试验,杂志文章
doi:10.1080/15284336.2015.1115585
更新日期:2016-02-01 00:00:00
abstract:PURPOSE:To investigate the factors that contribute to willingness to participate in HIV clinical trials and to determine the impact of a brief intervention on willingness to participate. METHODS:115 consecutive outpatients receiving HIV primary care participated in this prospective study. Each patient completed a ques...
journal_title:HIV clinical trials
pub_type: 杂志文章
doi:10.1310/hct1002-104
更新日期:2009-03-01 00:00:00
abstract:UNLABELLED:Patients with prior virologic failure (VF) are at an increased risk of subsequent failure, emergence of resistance, and death. This analysis identifies outcomes and correlates of VF in a high-risk population. METHODS:A5251 was designed to evaluate an enhanced adherence counseling intervention delivered by n...
journal_title:HIV clinical trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1080/15284336.2016.1189754
更新日期:2016-07-01 00:00:00
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::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: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: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:INTRODUCTION:It is not uncommon for patients with HIV infection to miss scheduled visits in outpatient clinics without justifying the failure to appear or reschedule the appointment. Few studies have assessed the impact of inconsistent follow-ups on resource use and disease outcomes in this patient population. OBJECTI...
journal_title:HIV clinical trials
pub_type: 杂志文章
doi:10.1310/hct1305-289
更新日期:2012-09-01 00:00:00