Effectiveness and safety of tenofovir gel, an antiretroviral microbicide, for the prevention of HIV infection in women.
Effectiveness and safety of tenofovir gel, an antiretroviral microbicide, for the prevention of HIV infection in women.
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DOI：
10.1126/science.1193748
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发表时间：
2010-09-03
期刊：
影响因子：
--
通讯作者：
CAPRISA 004 Trial Group
中科院分区：
文献类型：
--
作者：
Abdool Karim Q;Abdool Karim SS;Frohlich JA;Grobler AC;Baxter C;Mansoor LE;Kharsany AB;Sibeko S;Mlisana KP;Omar Z;Gengiah TN;Maarschalk S;Arulappan N;Mlotshwa M;Morris L;Taylor D;CAPRISA 004 Trial Group
CAPRISA 004试验评估了1%阴道凝胶制剂替诺福韦（tenofovir，一种核苷酸逆转录酶抑制剂）预防女性HIV感染的有效性和安全性。在南非夸祖鲁-纳塔尔省城市和农村的18-40岁性活跃、未感染艾滋病毒的妇女中进行了一项双盲、随机对照试验，比较了替诺福韦凝胶（n=445）和安慰剂凝胶（n=444），每月随访30个月，评估艾滋病毒血清状况、安全性、性行为以及凝胶和避孕套的使用情况。替诺福韦凝胶组的HIV发病率为5.6 / 100女性年（38/680.6），即研究观察的人时间（38/680.6），而安慰剂凝胶组为9.1 / 100女性年（60/660.7）(发病率比(IRR)=0.61；p = 0.017)。在高黏附者（凝胶黏附率为80%）中，替诺福韦凝胶组的HIV感染率降低了54% （p=0.025）。在中等黏附者（凝胶黏附率50-80%）和低黏附者（凝胶黏附率< 50%）中，HIV感染率分别降低38%和28%。替诺福韦凝胶总体上减少了39%的艾滋病毒感染，在凝胶依从性高的妇女中减少了54%。总体不良事件发生率未见增加。HIV感染者的病毒载量没有变化，也没有替诺福韦耐药。替诺福韦凝胶可能潜在地填补一个重要的艾滋病预防空白，特别是对于那些无法成功协商相互一夫一妻制或使用避孕套的妇女。
The CAPRISA 004 trial assessed effectiveness and safety of a 1% vaginal gel formulation of tenofovir, a nucleotide reverse transcriptase inhibitor, for the prevention of HIV acquisition in women. A double-blind, randomized controlled trial was conducted comparing tenofovir gel (n=445) with placebo gel (n=444) in sexually active, HIV-uninfected 18-40 year-old women in urban and rural KwaZulu-Natal, South Africa HIV serostatus, safety, sexual behavior and gel and condom use were assessed at monthly follow-up visits for 30 months. HIV incidence in the tenofovir gel arm was 5.6 per 100 women-years (wy), i.e. person time of study observation, (38/680.6wy) compared to 9.1 per 100 wy (60/660.7wy) in the placebo gel arm (Incidence Rate Ratio (IRR)=0.61; p=0.017).In high adherers (gel adherence >80%), HIV incidence was 54% lower (p=0.025) in the tenofovir gel arm. In intermediate adherers (gel adherence 50-80%) and low adherers (gel adherence < 50%) the HIV incidence reduction was 38% and 28% respectively. Tenofovir gel reduced HIV acquisition by an estimated 39% overall, and by 54% in women with high gel adherence. No increase in the overall adverse event rates was observed. There were no changes in viral load and no tenofovir resistance in HIV seroconvertors. Tenofovir gel could potentially fill an important HIV prevention gap, especially for women unable to successfully negotiate mutual monogamy or condom use.
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影响因子：
3.7
作者：
Rohan LC;Moncla BJ;Kunjara Na Ayudhya RP;Cost M;Huang Y;Gai F;Billitto N;Lynam JD;Pryke K;Graebing P;Hopkins N;Rooney JF;Friend D;Dezzutti CS
通讯作者：
Dezzutti CS
DOI：
10.1097/qad.0b013e328337798a
发表时间：
2010-03-13
期刊：
AIDS (London, England)
影响因子：
--
作者：
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通讯作者：
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影响因子：
168.9
作者：
Jackson, JB;Musoke, P;Mmiro, F
通讯作者：
Mmiro, F
影响因子：
5.8
作者：
De Clercq, E.
通讯作者：
De Clercq, E.
影响因子：
1.7
作者：
Kharsany AB;Karim QA;Karim SS
通讯作者：
Karim SS