A PHASE II PHARMACOKINETIC STUDY OF THE TRANSDERMAL CONTRACEPTIVE SYSTEM AND
A PHASE II PHARMACOKINETIC STUDY OF THE TRANSDERMAL CONTRACEPTIVE SYSTEM AND
批准号:
7717525
负责人:
Kenneth H. Fife
金额:
$0.45万
依托单位国家:
美国
项目类别:
财政年份:
2007
资助国家:
美国
项目状态:
已结题
起止时间:
2007-12-01 至 2008-05-31
关键词:
AgeClinicalComputer Retrieval of Information on Scientific Projects DatabaseContraceptive AgentsCountDoseDrug KineticsEnrollmentEthinyl EstradiolFundingGrantHIV-1InstitutionLabelLaboratoriesLopinavir/RitonavirMeasuresMenstrual fluidMenstruationMonitorOral ContraceptivesOrtho EvraOrtho-NovumPhasePlasmaProtease InhibitorQuestionnairesRandomizedResearchResearch PersonnelResourcesSourceSystemTelephoneTestingTreatment ProtocolsUnited States National Institutes of HealthVisitWeekWomanantiretroviral therapynon-nucleoside reverse transcriptase inhibitorsnorelgestrominreproductive
中文摘要
这个子项目是许多研究子项目中利用
资源由NIH/NCRR资助的中心拨款提供。子项目和
调查员(PI)可能从NIH的另一个来源获得了主要资金,
并因此可以在其他清晰的条目中表示。列出的机构是
该中心不一定是调查人员的机构。
这项开放标签和非随机药代动力学(PK)研究将在HIV-1感染育龄妇女中检验含有稳定的蛋白酶抑制(PI)方案(Lopinavir/ritonavir[LPV/r])和透皮避孕系统(TCS)Ortho Evra?Patch之间的相互作用。此外,还将研究LPV/r对单剂口服避孕药Ortho Novum(On 1/35)中乙炔雌二醇(EE)PK的影响。为了确定使用Ortho Evra贴片的LPV/r对EE PK的影响,该研究将监测LPV/r稳定的受试者和没有接受PI、非核苷类逆转录酶抑制剂(NNRTI)或任何抗逆转录病毒(ARV)治疗的受试者在贴片周期第3周(研究周月经(M)+3至M+4)内的EE水平。在贴片周期的第3周,还将测定去甲孕酮(NGMN)PK。这项研究将比较开始使用Ortho Evra贴片前后的血浆HIV-1RNA、CD4+/CD8+计数和临床参数。全国将招收54个科目,当地预计招收约10个科目。受试者将接受体检、实验室测试和问卷填写。在不到三个月的时间内,将进行10次考察访问和1次电话联系。
英文摘要
This subproject is one of many research subprojects utilizing the
resources provided by a Center grant funded by NIH/NCRR. The subproject and
investigator (PI) may have received primary funding from another NIH source,
and thus could be represented in other CRISP entries. The institution listed is
for the Center, which is not necessarily the institution for the investigator.
This open label and non-randomized pharmacokinetic (PK) study will examine the interaction between a stable protease inhibitor (PI)-containing regimen, (lopinavir/ritonavir [LPV/r]), and the transdermal contraceptive system (TCS), ORTHO EVRA¿ patch, in HIV-1-infected women of reproductive age. The effect of LPV/r on the ethinyl estradiol (EE) PK of single dose oral contraceptive Ortho Novum (ON 1/35) will also be studied. To determine the effect of LPV/r on EE PK with the ORTHO EVRA patch, the study will monitor EE levels during the patch cycle week 3 (study weeks menses (M)+3 to M+4) in subjects on stable LPV/r and subjects who are not receiving PIs, non-nucleoside reverse transcriptase inhibitors (NNRTIs), or any antiretroviral (ARV) therapy. Norelgestromin (NGMN) PK will also be measured during patch cycle week 3. The study will compare plasma HIV-1 RNA, CD4+/CD8+ counts, and clinical parameters before and after the initiation of the ORTHO EVRA patch. Nationally, 54 subjects will be enrolled with local expected enrolled to be approximately 10 subjects. Subjects will undergo physical exams, laboratory testing, and questionnaire completion. There will be 10 study visits and one telephone contact within a period of less than three months.
期刊论文(0)
专著(0)
科研奖励(0)
会议论文
PATIENT EVALUATION FOR POTENTIAL AIDS CLINICAL TRIAL PARTICIPANTS
-
批准号:7606364
-
项目类别:
-
资助金额:$29.35万
-
财政年份:2006
-
负责人:Kenneth H. Fife
-
依托单位:
A PHASE II PHARMACOKINETIC STUDY OF THE TRANSDERMAL CONTRACEPTIVE SYSTEM AND
-
批准号:7606428
-
项目类别:
-
资助金额:$1.91万
-
财政年份:2006
-
负责人:Kenneth H. Fife
-
依托单位:
PATIENT EVALUATION FOR POTENTIAL AIDS CLINICAL TRIAL PARTICIPANTS
-
批准号:7205733
-
项目类别:
-
资助金额:$21.69万
-
财政年份:2005
-
负责人:Kenneth H. Fife
-
依托单位:
PREVALENCE OF HPV DNA IN HIV INFECTED WOMEN WHO HAVE INITIATED HAART (A5029)
-
批准号:7379061
-
项目类别:
-
资助金额:$0.22万
-
财政年份:2005
-
负责人:Kenneth H. Fife
-
依托单位:
HIV-INFECTED SUBJECTS WHO PARTICIPATED IN ACTG 388 & HAVE <200 HIV-1 RNA A5116
-
批准号:7205765
-
项目类别:
-
资助金额:$1.91万
-
财政年份:2005
-
负责人:Kenneth H. Fife
-
依托单位:
A PHASE II PHARMACOKINETIC STUDY OF THE TRANSDERMAL CONTRACEPTIVE SYSTEM AND
-
批准号:7379132
-
项目类别:
-
资助金额:$0.15万
-
财政年份:2005
-
负责人:Kenneth H. Fife
-
依托单位:
EVALUATION OF METABOLIC COMPLICATIONS ASSOCIATED WITH ANTIRETROVIRAL MEDICATIONS
-
批准号:7205772
-
项目类别:
-
资助金额:$0.56万
-
财政年份:2005
-
负责人:Kenneth H. Fife
-
依托单位:
DEPO-MEDROXYPROGESTERONE ACETATE AND SELECTED PROTEASE INHIBITOR
-
批准号:7205787
-
项目类别:
-
资助金额:$0.56万
-
财政年份:2005
-
负责人:Kenneth H. Fife
-
依托单位:
PREVALENCE OF HPV DNA IN HIV INFECTED WOMEN WHO HAVE INITIATED HAART (A5029)
-
批准号:7205759
-
项目类别:
-
资助金额:$0.16万
-
财政年份:2005
-
负责人:Kenneth H. Fife
-
依托单位:
PATIENT EVALUATION FOR POTENTIAL AIDS CLINICAL TRIAL PARTICIPANTS
-
批准号:7379042
-
项目类别:
-
资助金额:$21.64万
-
财政年份:2005
-
负责人:Kenneth H. Fife
-
依托单位:
HIV-Infected Subjects Who Participated in ACTG 388 & Have <200 HIV-1 RNA A5116
-
批准号:7045169
-
项目类别:
-
资助金额:$2.25万
-
财政年份:2003
-
负责人:Kenneth H. Fife
-
依托单位:
DEPO-MEDROXYPROGESTERONE ACETATE AND SELECTED PROTEASE INHIBITOR...
-
批准号:7045194
-
项目类别:
-
资助金额:$1.94万
-
财政年份:2003
-
负责人:Kenneth H. Fife
-
依托单位:
Prolongation of Viro.success, options for Viro.failure in HIV infected (ACTG372)
-
批准号:7045129
-
项目类别:
-
资助金额:$0.86万
-
财政年份:2003
-
负责人:Kenneth H. Fife
-
依托单位:
Prevalence of HPV DNA in HIV infected women who have initiated HAART (A5029)
-
批准号:7045158
-
项目类别:
-
资助金额:$0.16万
-
财政年份:2003
-
负责人:Kenneth H. Fife
-
依托单位:
EVALUATION OF METABOLIC COMPLICATIONS ASSOCIATED WITH ANTIRETROVIRAL MEDICATIONS
-
批准号:7045180
-
项目类别:
-
资助金额:$0.23万
-
财政年份:2003
-
负责人:Kenneth H. Fife
-
依托单位:
Patient Evaluation for Potential AIDS Clinical Trial Participants
-
批准号:7045119
-
项目类别:
-
资助金额:$22.78万
-
财政年份:2003
-
负责人:Kenneth H. Fife
-
依托单位:
COMPARISON OF THE VIROLOGIC EFFICACY OF NULFINAVIR/DMP 266 IN COMBINATION
-
批准号:6117870
-
项目类别:
-
资助金额:$1.7万
-
财政年份:1998
-
负责人:Kenneth H. Fife
-
依托单位:
INFLUENCE OF RISK FOR DISEASE PROGRESSION ON RESPONSE TO ANTIRETROVIRAL THERAPY
-
批准号:6117783
-
项目类别:
-
资助金额:$1.7万
-
财政年份:1998
-
负责人:Kenneth H. Fife
-
依托单位:
OPEN LABEL TREATMENT OF HIV INFECTED SUBJECT WITH TIMUNOX
-
批准号:6290949
-
项目类别:
-
资助金额:$1.7万
-
财政年份:1998
-
负责人:Kenneth H. Fife
-
依托单位:
PATIENT EVALUATION FOR POTENTIAL AIDS CLINICAL TRIAL PARTICIPANTS
-
批准号:6117742
-
项目类别:
-
资助金额:$1.7万
-
财政年份:1998
-
负责人:Kenneth H. Fife
-
依托单位:
国内基金
海外基金
Molecular Interaction Reconstruction of Rheumatoid Arthritis Therapies Using Clinical Data
-
批准号:31070748
-
项目类别:面上项目
-
资助金额:34.0万元
-
批准年份:2010
-
负责人:Christine Nardini
-
依托单位: