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, lamivudine, and other nucleoside analogues were offered to highly pretreated patients who had advanced HIV-1 infection and who had failed at least 2 previous highly active antiretroviral therapy regimens including at least 1 nonnucleoside reverse transcriptase inhibitor. The relationship between baseline drug resistance and steady-state saquinavir serum levels and early (week 4) and sustained (week 48) virologic response was documented. RESULTS:35 advanced HIV-1 patients were enrolled. The boosted double-PI regimen was well tolerated. Twenty-two (63%) of the 35 patients had a > 0.8 log(10) decrease in HIV viral load at week 4. After 48 weeks of follow-up, the 22 patients who remained on the study therapy had an average decrease in viral load of 1 log(10) and had a median increase in CD4 cells of 60 cell/microL. Multiple logistic regression analysis indicated that genotypic resistance to both PIs and the week-3 trough concentrations of saquinavir were associated with virologic outcome at week 4. The presence of > or = 6 lopinavir mutations [odds ratio (OR) 0.03; 95% CI 0.01 to 0.79] and the 48V mutation (OR 0.01; 95%CI <0.01 to 0.88) was independently associated with lower odds of achieving an early response, whereas a higher saquinavir concentration at week 3 (OR 8.36; 95% CI 1.28 to 54.70) was associated with greater odds of an early response. CONCLUSION:These findings suggest that baseline PI resistance and saquinavir concentration were associated with virologic response and should be considered when planning salvage therapy.
journal_name
HIV Clin Trialsjournal_title
HIV clinical trialsauthors
Smith GH,Boulassel MR,Klien M,Gilmore N,MacLeod J,LeBlanc R,René P,Routy JP,Lalonde RGdoi
10.1310/HAG3-8YA5-UDQC-36NXkeywords:
subject
Has Abstractpub_date
2005-03-01 00:00:00pages
63-72issue
2eissn
1528-4336issn
1945-5771journal_volume
6pub_type
临床试验,杂志文章abstract::Three HIV individuals with chronic hepatitis C presented with esophageal variceal bleeding. They had mild liver fibrosis and normal liver function tests. All had received didanosine for long periods. Noncirrhotic portal hypertension associated with didanosine may appear in HIV patients without any liver disease or add...
journal_title:HIV clinical trials
pub_type: 杂志文章
doi:10.1310/hct0906-440
更新日期:2008-11-01 00:00:00
abstract:BACKGROUND:Raltegravir (RAL) constitutes the first available integrase strand transfer inhibitor (INSTI) available in clinical practice. Three independent pathways have been described to confer resistance to RAL. Secondary mutations with little effect on INSTI susceptibility and additional substitutions with an uncerta...
journal_title:HIV clinical trials
pub_type: 杂志文章,多中心研究
doi:10.1310/hct1401-10
更新日期:2013-01-01 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: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/...
journal_title:HIV clinical trials
pub_type: 临床试验,杂志文章
doi:10.1310/hct1304-179
更新日期:2012-07-01 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: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:BACKGROUND:To improve the dosing frequency and pill burden of antiretroviral therapy, we compared two once-daily dosed regimens to a twice-daily dosed regimen. METHOD:HIV-1-infected, antiretroviral drug-naïve adults were randomized to either twice-daily nelfinavir and stavudine and once-daily didanosine (regimen A) or...
journal_title:HIV clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1310/A686-M37Y-J2PT-E9GJ
更新日期:2005-09-01 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: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:BACKGROUND:Exercise training has been shown to be an effective strategy to balance oxidative stress status; however, this is underexplored in people living with HIV/AIDS (PLWHA). OBJECTIVE:To evaluate the effects of exercise training on oxidative stress in PLWHA receiving antiretroviral therapy. METHODS:Patients perf...
journal_title:HIV clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1080/15284336.2018.1481247
更新日期:2018-08-01 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: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: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:This retrospective study investigates the effect of prior nucleoside (nucleoside reverse transcriptase inhibitor [NRTI]) experience on 2-year virologic response to an initial protease inhibitor-highly active antiretroviral therapy (PI-HAART) regimen. METHOD:152 patients who started a PI (excluding saquinavir h...
journal_title:HIV clinical trials
pub_type: 临床试验,杂志文章
doi:10.1310/W17C-5DBH-D90E-17CG
更新日期:2001-05-01 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:BACKGROUND:Endothelial progenitor cells (EPCs) are bone marrow-derived cells that contribute to vascular repair. EPCs may be reduced in HIV-infected (HIV+) persons, contributing to cardiovascular disease (CVD). Telmisartan is an angiotensin receptor blocker that increases EPCs in HIV-uninfected adults. OBJECTIVE:To as...
journal_title:HIV clinical trials
pub_type: 杂志文章
doi:10.1080/15284336.2016.1234222
更新日期:2016-11-01 00:00:00
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,...
journal_title:HIV clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1310/hct1505-218
更新日期:2014-09-01 00:00:00
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:BACKGROUND:In recent ritonavir-boosted protease inhibitor (PI) studies, high efficacy rates have been observed, with few PI mutations detected. METHOD:To better understand the types of mutations observed and their phenotypic impact and the likelihood of virologic failure (VF) on a regimen that includes either a ritona...
journal_title:HIV clinical trials
pub_type: 杂志文章,meta分析
doi:10.1310/hct0706-334
更新日期:2006-11-01 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: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: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::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: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
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:PURPOSE:To assess factors associated with adherence, particularly pill burden, to combination antiretroviral therapy (cART) using multivariate models. METHOD:A cross-sectional survey of US adults with a self-reported diagnosis of HIV/AIDS was conducted between April and May 2007. Respondents on a cART regimen of at le...
journal_title:HIV clinical trials
pub_type: 杂志文章
doi:10.1310/hct1202-71
更新日期:2011-03-01 00:00:00
abstract:OBJECTIVE:To determine the prevalence of CCR5-tropic HIV-1 among treatment-experienced patients in Spain. DESIGN:Epidemiologic, cross-sectional, and non-interventional study between January and June 2008 in HIV-1-infected patients in Spain. METHODS:A total of 485 treatment-experienced patients from across Spainand wi...
journal_title:HIV clinical trials
pub_type: 杂志文章
doi:10.1310/hct1006-394
更新日期:2009-11-01 00:00:00
abstract:BACKGROUND:Some individuals control HIV replication without antiretroviral (ARV) therapy. OBJECTIVE:To analyze viral suppression in young women in rural South Africa enrolled in a trial evaluating a behavioral intervention for HIV prevention. METHODS:Plasma samples were obtained from women ages 13-24 (81 infected at ...
journal_title:HIV clinical trials
pub_type: 杂志文章
doi:10.1080/15284336.2018.1531534
更新日期:2018-10-01 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: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