Abstract:
INTRODUCTION:Vaginal tenofovir (TFV) 1% gel may reduce incident HIV-1 and herpes simplex virus 2 infection. Pregnancy may increase risk of HIV acquisition, and incident HIV in pregnancy potentiates perinatal HIV transmission. Our objective was to investigate the safety and pharmacokinetics of seven days of TFV 1% vaginal gel in term and near-term pregnancy. METHODS:Ninety-eight healthy pregnant women, stratified to a term cohort followed by a near-term cohort, were enrolled into a 2:1 randomized, double-blinded, placebo-controlled trial. Women received TFV or placebo gel for seven consecutive days with pharmacokinetic sampling on days 0 and 6. Maternal and cord blood were collected at delivery. Primary end points included laboratory and genital adverse events, adverse pregnancy and neonatal outcomes, and maternal TFV levels. RESULTS:Most adverse events were grade 1 and none of the grade 3 or 4 adverse events were related to study product. There was no significant difference in safety end points between the two pregnancy cohorts (p=0.18); therefore, their data were combined. Primary safety end point rates were similar for mothers randomized to the TFV gel vs placebo arm (72.7 and 68.8%, p=0.81). The same was true for newborns in the TFV gel vs placebo arms (4.5% vs 6.3%, p=0.66). All women randomized to TFV had quantifiable serum levels within eight hours of dosing, with low overall median (interquartile range) day 0 and day 6 peak values (3.8 (2.0 to 7.0) and 5.8 (2.6 to 9.4) ng/mL, respectively). CONCLUSIONS:Daily TFV 1% vaginal gel use in term and near-term pregnancy appears to be safe and produces low serum drug levels.
journal_name
J Int AIDS Socjournal_title
Journal of the International AIDS Societyauthors
Beigi RH,Noguchi LM,Montgomery E,Biggio J,Hendrix CW,Marzinke MA,Dai JY,Pan J,Kunjara Na Ayudhya R,Schwartz JL,Isaacs K,Piper JM,Watts DHdoi
10.7448/IAS.19.1.20990subject
Has Abstractpub_date
2016-09-21 00:00:00pages
20990issue
1issn
1758-2652pii
20990journal_volume
19pub_type
杂志文章abstract:INTRODUCTION:Engaging at-risk men in HIV prevention programs and services is a current priority, yet there are few effective ways to identify which men are at highest risk or how to best reach them. In this study we generated multi-factor profiles of HIV acquisition/transmission risk for men in Durban, South Africa, to...
journal_title:Journal of the International AIDS Society
pub_type: 杂志文章
doi:10.1002/jia2.25518
更新日期:2020-06-01 00:00:00
abstract::The strength of the evidence linking concurrency to HIV epidemic severity in southern and eastern Africa led the Joint United Nations Programme on HIV/AIDS and the Southern African Development Community in 2006 to conclude that high rates of concurrent sexual partnerships, combined with low rates of male circumcision ...
journal_title:Journal of the International AIDS Society
pub_type: 杂志文章,评审
doi:10.1186/1758-2652-14-13
更新日期:2011-03-15 00:00:00
abstract:INTRODUCTION:HIV prevalence is declining in key populations in Armenia including in people who inject drugs (PWID), men who have sex with men, prison inmates, and female sex workers (FSWs); however, prevalence is increasing among Armenians who seasonally migrate to work in countries with higher HIV prevalence, primaril...
journal_title:Journal of the International AIDS Society
pub_type: 杂志文章
doi:10.7448/IAS.19.1.20772
更新日期:2016-06-07 00:00:00
abstract::Improved knowledge, better programmes and policies, effective treatment and other scientific developments have reduced levels of new HIV infections globally. Evidence shows that programmes that prevent HIV among sex workers and their clients are most successful when all aspects of vulnerability are addressed and when ...
journal_title:Journal of the International AIDS Society
pub_type: 杂志文章
doi:10.7448/IAS.16.1.18459
更新日期:2013-08-29 00:00:00
abstract:INTRODUCTION:HIV testing is an essential prerequisite for accessing treatment with antiretroviral therapy or prevention using pre-exposure prophylaxis. Internet distribution of HIV self-tests is a novel approach, and data on the programmatic cost of this approach are limited. We analyse the costs and cost-effectiveness...
journal_title:Journal of the International AIDS Society
pub_type: 杂志文章,随机对照试验
doi:10.1002/jia2.25445
更新日期:2020-01-01 00:00:00
abstract:INTRODUCTION:Several factors such as duration of infection, age, male gender, consumption of alcohol, HIV infection and low CD4 count have been associated with fibrosis progression rate. However, it is relatively scarce, the knowledge about the liver fibrosis progression rate in HIV-infected patients with undetectable ...
journal_title:Journal of the International AIDS Society
pub_type: 杂志文章
doi:10.7448/IAS.17.4.19636
更新日期:2014-11-02 00:00:00
abstract:INTRODUCTION:Lamivudine (3TC) and emtricitabine (FTC) are considered interchangeable by HIV-1 guidelines in first-line tenofovir/efavirenz (TDF/EFV) and TDF/nevirapine (NVP) combination antiretroviral therapy (cART). Data from trials on equivalence of 3TC and FTC are inconsistent. We examined the effectiveness of 3TC a...
journal_title:Journal of the International AIDS Society
pub_type: 杂志文章
doi:10.7448/IAS.17.4.19491
更新日期:2014-11-02 00:00:00
abstract:INTRODUCTION:Consistent use of PrEP reduces HIV transmission from sexual practices amongst men who have sex with men (MSM) up to 92% [1]. Lisbon MSM cohort study estimates point that 59.3% of their participants at entrance (1593 HIV negative MSM enrolled between April 2011 and May 2013) were eligible for PrEP [2], acco...
journal_title:Journal of the International AIDS Society
pub_type: 杂志文章
doi:10.7448/IAS.17.4.19734
更新日期:2014-11-02 00:00:00
abstract:INTRODUCTION:The evolving HIV epidemic, coupled with advances in HIV treatment, has resulted in an ageing HIV-diagnosed population. It has been suggested that adverse physical and psychological effects of HIV may be higher among older people. However, few studies have examined the effect of older age on well-being for ...
journal_title:Journal of the International AIDS Society
pub_type: 杂志文章
doi:10.7448/IAS.17.4.19511
更新日期:2014-11-02 00:00:00
abstract:INTRODUCTION:Achieving UNAIDS 90-90-90 targets is a crucial step towards ending the AIDS epidemic. Many countries have published estimates of care cascades, although often with methodological limitations. We describe an approach that used the national HIV registry as a starting-point to determine the HIV care cascade a...
journal_title:Journal of the International AIDS Society
pub_type: 杂志文章
doi:10.1002/jia2.25356
更新日期:2019-07-01 00:00:00
abstract:INTRODUCTION:In 2013, the World Health Organization (WHO) recommended initiating combination ART (cART) in all adults with HIV and CD4+ lymphocyte counts (CD4) <500 cells/mm3 . In 2015, this was updated to recommend cART initiation in all patients with HIV, regardless of CD4 count. Implementation of these guidelines in...
journal_title:Journal of the International AIDS Society
pub_type: 杂志文章
doi:10.1002/jia2.25413
更新日期:2019-12-01 00:00:00
abstract:INTRODUCTION:Rilpivirine (RPV) is a second-generation non-nucleoside reverse transcriptase inhibitor (NNRTI) that was recently approved for the treatment of antiretroviral-naïve individuals with HIV-1 viral load of <100,000 copies/ml. As transmission of the drug resistance mutations to this NNRTI may affect treatment o...
journal_title:Journal of the International AIDS Society
pub_type: 杂志文章
doi:10.7448/IAS.17.1.18929
更新日期:2014-04-17 00:00:00
abstract:INTRODUCTION:As prevalence of undiagnosed HIV declines, it is unclear whether testing programmes will be cost-effective. To guide their HIV testing programmes, countries require appropriate metrics that can be measured. The cost-per-diagnosis is potentially a useful metric. METHODS:We simulated a series of setting-sce...
journal_title:Journal of the International AIDS Society
pub_type: 杂志文章
doi:10.1002/jia2.25325
更新日期:2019-07-01 00:00:00
abstract:BACKGROUND:While the number of HIV-positive patients on antiretroviral therapy (ART) in resource-limited settings has increased dramatically, some patients eligible for treatment do not initiate ART even when it is available to them. Understanding why patients opt out of care, or are unable to opt in, is important to a...
journal_title:Journal of the International AIDS Society
pub_type: 杂志文章
doi:10.1186/1758-2652-13-8
更新日期:2010-03-06 00:00:00
abstract:INTRODUCTION:In 2016, the Global Health Sector Strategy (GHSS) on viral hepatitis called for elimination of viral hepatitis as a major public health threat by 2030 (i.e. 90% reduction in incidence and 65% in mortality). In 2017, WHO's first-ever Global Hepatitis Report presented the baseline values for each of the core...
journal_title:Journal of the International AIDS Society
pub_type: 杂志文章,评审
doi:10.1002/jia2.25050
更新日期:2018-04-01 00:00:00
abstract::Family-based interventions with children who are affected by HIV and AIDS are not well established. The Collaborative HIV Prevention and Adolescent Mental Health Program (CHAMP) represents one of the few evidence-based interventions tested in low-income contexts in the US, Caribbean and South Africa. This paper provid...
journal_title:Journal of the International AIDS Society
pub_type: 杂志文章,评审
doi:10.1186/1758-2652-13-S2-S8
更新日期:2010-06-23 00:00:00
abstract:INTRODUCTION:Global guidelines emphasize the ethical obligation of investigators to help participants in HIV-endpoint trials reduce HIV risk by offering an optimal HIV prevention package. Oral pre-exposure prophylaxis (PrEP) has increasingly become part of state-of-the-art HIV prevention. Here we describe the process o...
journal_title:Journal of the International AIDS Society
pub_type: 杂志文章,随机对照试验
doi:10.1002/jia2.25491
更新日期:2020-05-01 00:00:00
abstract:INTRODUCTION:Most clinical trials for new antiretroviral (ARV) agents are conducted among narrowly defined adult populations. Only after safety and efficacy have been clearly demonstrated among adults living with HIV are trials including adolescents, children and infants conducted. This approach contributes to signific...
journal_title:Journal of the International AIDS Society
pub_type: 杂志文章
doi:10.1002/jia2.25576
更新日期:2020-09-01 00:00:00
abstract:INTRODUCTION:Men who have sex with men (MSM) and transgender women (TGW) are two key populations (KPs) in Thailand at high risk for HIV. Uptake and scale-up of pre-exposure prophylaxis (PrEP) among them has been slow. We used data from Princess PrEP, Thailand's largest KP-led PrEP programme, to operationalize PrEP serv...
journal_title:Journal of the International AIDS Society
pub_type: 杂志文章
doi:10.1002/jia2.25540
更新日期:2020-06-01 00:00:00
abstract:INTRODUCTION:HIV testing is a cornerstone of efforts to combat the HIV epidemic, and testing conducted as part of surveillance provides invaluable data on the spread of infection and the effectiveness of campaigns to reduce the transmission of HIV. However, participation in HIV testing can be low, and if respondents sy...
journal_title:Journal of the International AIDS Society
pub_type: 杂志文章
doi:10.7448/IAS.18.1.19954
更新日期:2015-11-26 00:00:00
abstract:INTRODUCTION:In 2014 the Joint United Nations Programme on HIV/AIDS defined the ambitious 90-90-90 targets for 2020, in which 90% of people living with HIV must be diagnosed, 90% of those diagnosed should be on sustained therapy and 90% of those on therapy should have an undetectable viral load. Children are considered...
journal_title:Journal of the International AIDS Society
pub_type: 杂志文章,评审
doi:10.7448/IAS.18.7.20236
更新日期:2015-12-02 00:00:00
abstract:INTRODUCTION:To be used most effectively, pre-exposure prophylaxis (PrEP) should be prioritized to those at high risk of acquisition and would ideally be aligned with time periods of increased exposure. Identifying such time periods is not always straightforward, however. Gaza Province in southern Mozambique is charact...
journal_title:Journal of the International AIDS Society
pub_type: 杂志文章
doi:10.7448/IAS.18.4.19946
更新日期:2015-07-20 00:00:00
abstract:INTRODUCTION:Evidence suggests that people who inject drugs often begin their drug use and injecting practices in adolescence, yet there are limited data available on the HIV epidemic and the responses for this population. The comprehensive package of interventions for the prevention, treatment and care of HIV infectio...
journal_title:Journal of the International AIDS Society
pub_type: 杂志文章
doi:10.7448/IAS.18.2.19442
更新日期:2015-02-26 00:00:00
abstract:INTRODUCTION:Two new microbicide products based on topical (vaginal) application of antiretroviral drugs - 1% tenofovir gel and the dapivirine ring - are currently in late-stage clinical testing, and results on their safety and effectiveness are expected to become available in early 2015. WHO guidelines on the use of t...
journal_title:Journal of the International AIDS Society
pub_type: 杂志文章
doi:10.7448/IAS.17.3.19279
更新日期:2014-09-08 00:00:00
abstract:INTRODUCTION:The long-term effects of an intensified induction regimen are unknown. In this pilot, randomized, prospective study we evaluate the effect of a short-term four-drugs induction regimen in patients with high baseline viral load. METHODS:Naive patients with HIV-RNA>100.000 copies/ml receiving TDF+FTC+EFV+RAL...
journal_title:Journal of the International AIDS Society
pub_type: 杂志文章
doi:10.7448/IAS.17.4.19776
更新日期:2014-11-02 00:00:00
abstract:INTRODUCTION:Limited data exist on acceptability of candidate pre-exposure prophylaxis (PrEP) regimens among US women. We evaluated PrEP experiences, attitudes and future use intentions among sexually active women who completed the US-based HIV Prevention Trials Network 069/AIDS Clinical Trials Group 5305 study. METHO...
journal_title:Journal of the International AIDS Society
pub_type: 杂志文章,随机对照试验
doi:10.1002/jia2.25247
更新日期:2019-03-01 00:00:00
abstract:INTRODUCTION:A severe healthcare worker shortage in sub-Saharan Africa is inhibiting the expansion of HIV treatment. Task shifting, the transfer of antiretroviral therapy (ART) management and initiation from doctors to nurses and other non-physician clinicians, has been proposed to address this problem. However, many h...
journal_title:Journal of the International AIDS Society
pub_type: 杂志文章,meta分析,评审
doi:10.7448/IAS.16.1.18445
更新日期:2013-07-03 00:00:00
abstract:INTRODUCTION:T cell immunoglobulin and mucin domain (Tim) 3 and programmed death 1 (PD-1) are co-inhibitory receptors involved in the so-called T cell exhaustion, and in vivo blockade of these molecules restores T cell dysfunction. High expression of Tim-3 and PD-1 is induced after chronic antigen-specific stimulation ...
journal_title:Journal of the International AIDS Society
pub_type: 杂志文章
doi:10.7448/IAS.18.1.20078
更新日期:2015-10-19 00:00:00
abstract:INTRODUCTION:HIV-controllers have the ability to spontaneously maintain viraemia at low or undetectable levels in the absence of antiretroviral treatment. Furthermore, HIV-controllers seem to have a superior capacity to spontaneously clear hepatitis C virus (HCV) compared to non HIV-controllers. Some of these subjects ...
journal_title:Journal of the International AIDS Society
pub_type: 杂志文章
doi:10.1002/jia2.25607
更新日期:2020-09-01 00:00:00
abstract:INTRODUCTION:HIV diagnoses among gay and bisexual men have increased over the past decade in Australia. HIV point-of-care testing (POCT) was introduced in Australia in 2011 as a strategy to increase HIV testing by making the testing process more convenient. We surveyed gay and bisexual men undergoing POCT to assess bar...
journal_title:Journal of the International AIDS Society
pub_type: 杂志文章
doi:10.7448/IAS.18.1.20221
更新日期:2015-08-27 00:00:00