Abstract:
BACKGROUND:This study aimed to test the hypothesis that the paediatric fixed-dose combination granule for reconstitution (comprising lamivudine/zidovudine/nevirapine 30/60/50 mg per 5 ml) as a test product is bioequivalent to the coadministered single entities of the referenced products. Fixed-dose combination anti-retroviral therapy provides adequate suppression of HIV-1 replication, provides barrier to the development of resistance, simplifies dosage regimen and improves adherence. METHODS:An open label, randomized, two-way crossover study was conducted on 24 health adults under fasted conditions, with a washout period of 14 days between treatments. A total of 15 blood samples were collected before dosing and up to 96 h post dosing. The drugs were extracted from plasma and anlaysed using a validated high performance liquid chromatography- ultraviolet method. Non- compartmental pharmacokinetic (PK) analysis was performed to obtain the PK parameters, maximum plasma concentration (C max), area under the curve of plasma concentration-time curves from the time zero to last measurable concentration (AUC0-t) and the area under the curve extrapolated to infinity (AUC 0-∞) ANOVA test was performed to determine the effect of model factors on the PK parameters. The two one-sided t-tests were performed on the log-transformed data to determine the 90% CL for the ratio of test to reference PK parameters. RESULTS:The drugs were well tolerated and safe with minimal adverse events. The ANOVA test indicated the absence of any significant effects ( P>0.05) due to the model parameters. The 90% Cl for the geometric mean ratio of the test/reference for the Cmax, AUC0-t and the AUC0-∞ for lamivudine, zidovudine and nevirapine were within 80-125% bioequivalence limits. CONCLUSIONS:This single dose randomized study found that the test and reference products met the criteria for bioequivalence in the fasting healthy adult volunteers.
journal_name
Antivir Therjournal_title
Antiviral therapyauthors
Esseku F,Joshi A,Oyegbile Y,Edowhorhu G,Gbadero D,Adeyeye Mdoi
10.3851/imp2310subject
Has Abstractpub_date
2013-01-01 00:00:00pages
205-12issue
2eissn
1359-6535issn
2040-2058journal_volume
18pub_type
杂志文章,随机对照试验,评审abstract:BACKGROUND:Among 141 HIV-HBV-coinfected patients treated with tenofovir in our centre, 87% were good-responders to therapy. Seven patients showed a delayed response to tenofovir. The present study was performed to evaluate the quasispecies variability and the in vitro drug susceptibility to approved antiviral drugs of ...
journal_title:Antiviral therapy
pub_type: 杂志文章
doi:10.3851/IMP1940
更新日期:2012-01-01 00:00:00
abstract:BACKGROUND:The multidrug resistance proteins (MRPs) form a subfamily within the ATP binding cassette transporters that confer resistance to a variety of structurally unrelated compounds. MRP4 has been reported to transport antiretroviral drugs out of cells in an active process. Although the main therapeutic effects of ...
journal_title:Antiviral therapy
pub_type: 杂志文章
doi:10.3851/IMP1468
更新日期:2009-01-01 00:00:00
abstract::The potential uses of serological tests that detect HCV core antigens in biological fluids are highlighted. The most common serological tests utilized to detect exposure to HCV rely on the detection of antibodies to HCV. However, these tests cannot distinguish between individuals who have resolved their infection and ...
journal_title:Antiviral therapy
pub_type: 杂志文章,评审
doi:10.3851/IMP2463
更新日期:2012-01-01 00:00:00
abstract:BACKGROUND:Antiviral and immune-modulating properties of low-molecular-weight heparin (LMWH) against coronaviridae have been reported by in vitro studies, but no in vivo evidence is yet available. We sought to know whether the timing of prophylactic doses of LMWH during the course of COVID-19 may affect the time to SAR...
journal_title:Antiviral therapy
pub_type: 杂志文章
doi:10.3851/IMP3377
更新日期:2021-01-18 00:00:00
abstract:BACKGROUND:Little is known about the prognostic factors of acute liver enzyme variations in HIV-hepatitis B virus (HBV)-coinfected patients. OBJECTIVES:To identify prognostic factors of acute liver enzyme abnormalities in HIV-HBV-coinfected patients with a focus on the putative role of antiretroviral drugs. DESIGN:Da...
journal_title:Antiviral therapy
pub_type: 杂志文章,多中心研究
doi:
更新日期:2007-01-01 00:00:00
abstract:BACKGROUND:Nucleoside reverse transcriptase inhibitor (NRTI)-associated mutations (NAMs) can affect response to treatment with NRTIs and might also result in HIV-1 with reduced replication capacity. METHODS:A large commercial HIV-1 database (n=60,487) was analysed for the prevalence of NAMs, antiviral drug susceptibil...
journal_title:Antiviral therapy
pub_type: 杂志文章
doi:
更新日期:2008-01-01 00:00:00
abstract:BACKGROUND:Hepatitis C virus genotype 1B responds poorly to treatment with interferon, in contrast to the more interferon-sensitive genotypes 2 and 3. Studies on combination therapy regimens with PEG-interferon and ribavirin report sustained response rates that generally do not exceed 50%, in contrast to sustained resp...
journal_title:Antiviral therapy
pub_type: 杂志文章,meta分析
doi:
更新日期:2004-04-01 00:00:00
abstract::Transmission of drug-resistant variants is influenced by several factors, including the prevalence of drug resistance in the population of HIV-1-infected patients, HIV-1 RNA levels and transmission by recently infected patients. In order to evaluate the impact of these factors on the transmission of drug-resistant var...
journal_title:Antiviral therapy
pub_type: 杂志文章
doi:
更新日期:2004-06-01 00:00:00
abstract:BACKGROUND:We examined the prevalence of ritonavir-boosted darunavir (DRV) resistance-associated mutations (RAMs) in HIV-infected children in the UK to determine the drug's potential clinical utility as a first-line or second-line protease inhibitor (PI). METHODS:The prevalence of DRV RAMs, identified from IAS 2010 an...
journal_title:Antiviral therapy
pub_type: 杂志文章
doi:10.3851/IMP2015
更新日期:2012-01-01 00:00:00
abstract::Neurological manifestations of HCV infection appear to be under-recognized in clinical practice despite the majority of HCV-infected patients experiencing symptoms such as fatigue, depression and cognitive dysfunction. There is also growing evidence for a link between HCV infection and an increased risk of Parkinson's...
journal_title:Antiviral therapy
pub_type: 杂志文章,评审
doi:10.3851/IMP3245
更新日期:2018-01-01 00:00:00
abstract:BACKGROUND:There is a paucity of data on the long-term efficacy of combination lamivudine and adefovir therapy in patients with lamivudine-resistant chronic hepatitis B. METHODS:We determined the cumulative virological, serological and biochemical outcomes of 165 lamivudine-resistant chronic hepatitis B patients on la...
journal_title:Antiviral therapy
pub_type: 杂志文章
doi:10.3851/IMP2335
更新日期:2012-01-01 00:00:00
abstract::In 1998 it seems reasonable and widely accepted that all human immunodeficiency virus type 1 (HIV-1)-infected patients willing to be treated may benefit from receiving antiretroviral therapy. Only those with undetectable plasma HIV-1 RNA, normal CD4 lymphocyte counts and lack of markers of immunological system activat...
journal_title:Antiviral therapy
pub_type: 杂志文章,评审
doi:
更新日期:1998-01-01 00:00:00
abstract:BACKGROUND:The development of infections with ganciclovir (GCV)-resistant human cytomegalovirus (HCMV) remains a serious problem in recipients of stem cell or organ transplants. Nearly all GCV-resistant clinical isolates have mutations in the viral UL97 gene. The rapid detection of GCV-resistant HCMV infections is nece...
journal_title:Antiviral therapy
pub_type: 杂志文章
doi:
更新日期:2008-01-01 00:00:00
abstract::Here, we describe a case of an HIV-infected patient with right lower limb oedema that appeared after initiation of tenofovir and emtricitabine treatment. The patient was fully investigated by serial heart and vessel echo-Doppler examination. Oedema of the lower limb was attributed to a transient drug-induced fivefold ...
journal_title:Antiviral therapy
pub_type: 杂志文章
doi:10.3851/IMP1302
更新日期:2009-01-01 00:00:00
abstract:BACKGROUND:Clinical utilization of genotype resistance testing is evolving. We examined the extent to which HIV care providers requesting genotype resistance tests used the information appropriately and the impact of inappropriate utilization. METHODS:Data from a prospective cohort of HIV-infected patients (the HIV Ou...
journal_title:Antiviral therapy
pub_type: 杂志文章
doi:
更新日期:2007-01-01 00:00:00
abstract:BACKGROUND:Few data are available about efficacy and durability of simplification from multi-tablet antiretroviral regimens to co-formulated efavirenz (EFV)/emtricitabine (FTC)/tenofovir (TDF) versus rilpivirine (RPV)/FTC/TDF in virologically suppressed HIV-1-infected patients. METHODS:We retrospectively analysed HIV-...
journal_title:Antiviral therapy
pub_type: 杂志文章,多中心研究
doi:10.3851/IMP3188
更新日期:2018-01-01 00:00:00
abstract:BACKGROUND:A significant proportion of hepatitis C patients treated with unmodified interferon plus ribavirin fail to respond. The optimal therapy for these patients has not been established yet. The objective of this study was to assess the efficacy and safety of peginterferon plus ribavirin with or without amantidine...
journal_title:Antiviral therapy
pub_type: 临床试验,杂志文章,随机对照试验
doi:
更新日期:2004-08-01 00:00:00
abstract:BACKGROUND:Insulin resistance (IR) was one of the first reported complications in HIV-positive patients who were receiving antiretroviral therapy (ART). However, the metabolic effects of newer fixed-dose ART combinations are unclear. METHODS:This Phase I prospective randomized open-label study evaluated the effects on...
journal_title:Antiviral therapy
pub_type: 杂志文章,随机对照试验
doi:10.3851/IMP3049
更新日期:2016-01-01 00:00:00
abstract:BACKGROUND:The H275Y neuraminidase mutation conferring oseltamivir resistance has been reported in several pandemic A/H1N1 (pH1N1) isolates. We sought to evaluate transmission of this mutant virus through the direct contact and the airborne (aerosol and droplet) routes in the ferret model. METHODS:Groups of four ferre...
journal_title:Antiviral therapy
pub_type: 杂志文章
doi:10.3851/IMP1794
更新日期:2011-01-01 00:00:00
abstract::There is a need for new antiretroviral drugs with activity against HIV isolates resistant to currently available agents and improved short and long-term tolerability profiles. Clinical trial designs for nucleotide and nucleoside reverse transcriptase inhibitors (NRTIs) are restricted by the characteristics of these ag...
journal_title:Antiviral therapy
pub_type: 杂志文章,评审
doi:
更新日期:2005-01-01 00:00:00
abstract:OBJECTIVE:To estimate the treatment and health care costs of HIV infection or AIDS in France during the era of highly active antiretroviral therapy (HAART). DESIGN:We used a clinical database of HIV-infected patients to calculate the resource use and cost of care for different stages of HIV infection. Costs were incor...
journal_title:Antiviral therapy
pub_type: 杂志文章
doi:
更新日期:2002-12-01 00:00:00
abstract:BACKGROUND:Regulatory T-cells (Treg) hamper immune responses elicited by cancer vaccines. Therefore, depletion of Treg is being used to improve the outcome of vaccinations. METHODS:We studied whether an alphavirus vector-based immunotherapeutic vaccine changes the number and/or activity of Treg and if Treg depletion i...
journal_title:Antiviral therapy
pub_type: 杂志文章
doi:10.3851/IMP1751
更新日期:2011-01-01 00:00:00
abstract:BACKGROUND/AIMS:The role of antibody in hepatitis C virus (HCV) infection remains unclear although many reports attest to its role in viral clearance. Here we describe epitopes that are recognized by antibody present in the serum of infected patients and show that such epitopes can induce neutralizing antibodies. METH...
journal_title:Antiviral therapy
pub_type: 杂志文章
doi:
更新日期:2006-01-01 00:00:00
abstract:BACKGROUND:In HIV-infected patients, therapeutic drug monitoring (TDM) of antiretroviral drugs is recommended in special populations and in specific situations to optimize therapy. Currently, TDM is performed via measurement of drug plasma concentrations; however, dried blood spots (DBS) may offer a patient friendly an...
journal_title:Antiviral therapy
pub_type: 杂志文章
doi:10.3851/IMP2501
更新日期:2013-01-01 00:00:00
abstract:BACKGROUND:Peripheral neuropathy (PN) in HIV-infected individuals is thought be due to a toxic effect on mitochondria induced by some nucleoside reverse transcriptase inhibitors (NRTI). METHODS:A time-to-event analysis was performed using data from the Delta trial to study the incidence of PN in HIV-infected individua...
journal_title:Antiviral therapy
pub_type: 杂志文章,随机对照试验
doi:
更新日期:2008-01-01 00:00:00
abstract:BACKGROUND:Although thiazolidinediones have been shown to increase subcutaneous fat in congenital lipodystrophy, rosiglitazone did not show convincing results in HIV lipoatrophy. We assess a potential specific effect of pioglitazone in this setting. METHODS:One-hundred and thirty HIV-1-infected adults with self-report...
journal_title:Antiviral therapy
pub_type: 杂志文章,多中心研究,随机对照试验
doi:
更新日期:2008-01-01 00:00:00
abstract:BACKGROUND:Rilpivirine-based regimens are now preferred or alternative first-line regimens according to many HIV treatment guidelines. Recently, a surveillance study conducted in Argentina determined that prevalence of pretreatment resistance to first-generation non-nucleoside reverse transcriptase inhibitors (NNRTIs) ...
journal_title:Antiviral therapy
pub_type: 杂志文章
doi:10.3851/IMP3147
更新日期:2017-01-01 00:00:00
abstract::The standard treatment of HCV infection with pegylated interferon-alpha2a or -alpha2b and ribavirin is effective in <50% of HCV genotype-1-infected patients. To improve this figure, it might be desirable to obtain optimal plasma concentrations of the drug by increasing the dose. Unfortunately, there is great interpati...
journal_title:Antiviral therapy
pub_type: 杂志文章,评审
doi:10.3851/IMP1609
更新日期:2010-01-01 00:00:00
abstract:OBJECTIVE:The aim of the study was to analyse the response to highly active antiretroviral therapy (HAART) initiated at the time of primary HIV infection (PHI) in patients infected with a virus resistant to > or = 1 drug of their treatment compared with patients infected with a wild-type virus. METHODS:We analysed dat...
journal_title:Antiviral therapy
pub_type: 杂志文章
doi:
更新日期:2007-01-01 00:00:00
abstract:BACKGROUND:Cidofovir (CDV) is an acyclic nucleoside phosphonate that exhibits a potent antiviral activity against several DNA viruses. In previous studies, CDV has been shown to significantly reduce the clinical severity and the viral shedding in primary caprine herpesvirus type-1 (CpHV-1) infection in goats. CpHV-1 is...
journal_title:Antiviral therapy
pub_type: 杂志文章
doi:10.3851/IMP1611
更新日期:2010-01-01 00:00:00