Abstract:
BACKGROUND:Simple antiretroviral drug combinations might provide a comparable benefit to standard triple regimens in patients with mild HIV disease, because poor adherence and toxicities often compromise the sustained benefit of the latest triple regimens, especially when protease inhibitors are used. Bad adherence is the main cause of virological failure in HIV-positive children. The activity and safety of a double combination of nucleosides with high genetic barrier for resistance (stavudine plus didanosine) was assessed in children with nonadvanced HIV disease. METHOD:From February 1998 to March 1999, 16 children were enrolled in six Spanish hospitals in a trial in which didanosine (180 mg/m2/day) and stavudine (2 mg/Kg/day) were administered for 48 weeks to asymptomatic naive children with plasma HIV RNA below 50,000 copies/mL and CD4 counts above 15%. Genotypic resistance to nucleoside analogues was examined at baseline and at the end of the study. RESULTS:At baseline, median age was 6.5 years (range, 2-14). The absolute and percentage mean CD4 counts were 864 and 32%, respectively (z score: -0.48 and -1.1). Mean plasma viral load was 4.05 log. No clinical events occurred during the 1-year study period. Minor side effects were recorded in two thirds of children, although none led to drug discontinuation. Lipoatrophy was not recognized in any of the participants. Plasma HIV RNA below 400 copies/mL was reached by 43% and 44% of patients at 24 and 48 weeks, respectively. The z score for absolute and percentage CD4 count increased significantly at 48 weeks (+0.63 and +0.97, respectively) in respect to baseline (p <.05). Resistance mutations linked to didanosine (L74V or M184V) or stavudine (V75T) were not recognized and neither were multinucleoside resistant genotypes (151 complex or 69 inserts). However, four children developed AZT-like mutations T215Y and/or M41L. CONCLUSION:Treatment with a dual combination of didanosine plus stavudine in naive children with nonadvanced HIV disease is safe and provides a satisfactory virological outcome at 1 year. Toxicity and drug resistance seem to occur rarely when this combination is used, which allows good adherence and spares other future treatment options.
journal_name
HIV Clin Trialsjournal_title
HIV clinical trialsauthors
de Mendoza C,Ramos JT,Ciria L,Fortuny C,García FJ,de José MI,Asensi F,Soriano Vdoi
10.1310/FAJF-7A8G-QAR4-Q0X5keywords:
subject
Has Abstractpub_date
2002-01-01 00:00:00pages
9-16issue
1eissn
1528-4336issn
1945-5771journal_volume
3pub_type
临床试验,杂志文章,多中心研究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: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: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: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: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: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: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: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: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: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: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: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: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::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 analyze the changes over two decades in HIV-infected pregnant women followed at a highly specialized regional center for antenatal care in southern Italy. METHOD:Since 1985, all HIV-infected pregnant women attending our center have been monitored using progressively updated protocols. RESULTS:By December 2...
journal_title:HIV clinical trials
pub_type: 杂志文章
doi:10.1310/hct0901-36
更新日期:2008-01-01 00:00:00
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:We hypothesized that nitazoxanide (NTZ) added to pegylated interferon alfa-2a (PEG-IFN) and weight-based ribavirin (WBR) would improve hepatitis C virus (HCV) virologic responses in HCV treatment-naïve HIV-1/HCV genotype 1 coinfected persons. METHODS:Prospective, single-arm study in which subjects received ...
journal_title:HIV clinical trials
pub_type: 临床试验,杂志文章
doi:10.1310/hct1406-274
更新日期:2013-11-01 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::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: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: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: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: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: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:BACKGROUND:The best method for assessment of functional status in human immunodeficiency virus type 1 (HIV-1) infected persons is unknown. OBJECTIVE:We hypothesized that 3 instruments to assess frailty or disability in elderly populations would perform similarly in HIV-1-infected persons. METHODS:HIV-infected subject...
journal_title:HIV clinical trials
pub_type: 杂志文章
doi:10.1310/hct1306-324
更新日期:2012-11-01 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: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: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: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::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