CTRI/2011/06/001796招募中2 期
A Phase II, open label, single arm trial to evaluate the pharmacokinetics,safety, tolerability, and antiviral activity of TMC278 in antiretroviralnaïveHIV-1 infected adolescents aged 12 to 18 years - PAINT study
Johnson and johnson Ltd0 个研究点目标入组 35 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 35
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Boys or girls, aged 12 to 18 years.
- •2. Subject?s weight is more thanor equal to 32 kg.
- •3. Subject with documented chronic HIV-1 infection who is aware of his/her HIV-1 diagnosis.
- •4.Subject has,prior to screening, never been treated with a therapeutic HIV vaccine or an
- •HIV drug with the exception of a single dose of NVP to prevent MTCT.
- •5. HIV-1 plasma viral load at screening 5,000 HIV1 RNA copies/mL (assayed by RNA polymerase chain reaction, standard specimen procedure).
- •6. In the judgment of the investigator, it is appropriate to initiate ARV therapy based on the
- •subject?s medical condition and taking into account guidelines for the treatment of HIV-1
- •infection in children of this age group.
- •Note: Most current treatment guidelines recommend considering initiation of ART when
- •CD4+ cell counts are less than 350 cells/mm³. However, clinical situations may warrant
- •initiating ART with CD4+ cell counts 350 cells/mm³.
- •7. Results from the screening virco® TYPE HIV-1 demonstrate sensitivity to the selected
- •N(t)RTIs using the lower CCO (indicated as ?maximal response? on the screening TYPE HIV-1 result) or the BCO (indicated as ?susceptible?), whichever is applicable for the chosen background regimen.
- •8. The subject agrees (or their parents/caregivers agree, in case the subjects age is below the cut-off age for consent according to local regulations, in which case the subject is informed and asked to give positive assent) not to start ART before the baseline visit.
- •9.General medical condition, in the investigator?s opinion, does not interfere with the assessments and the completion of the trial.
排除标准
- •Subjects meeting one or more of the following criteria cannot be selected:
- •1. Any previous use of ARVs, with the exception of a single dose of NVP to prevent MTCT.
- •Note: Subjects who were infected by MTCT are allowed to enter, provided the mother
- •was ARV treatment-naïve at the time of delivery with the exception of NVP for no
- •more than 3 days.
- •2. Having documented genotypic evidence of NNRTI resistance at screening or from
- •historical data available in the source documents, i.e., 1 NNRTI RAM from the
- •following list (the list was compiled on the basis of the list of IAS-USA NNRTI RAMs23
- •and other relevant publications).
- •A098G V106M Y181C G190S
- •L100I V108I Y181I G190T
- •K101E E138A Y181V P225H
- •K101P E138G Y188C F227C
- •K101Q E138K Y188H M230I
- •K103H E138Q Y188L M230L
- •K103N E138R G190A P236L
- •K103S V179E G190C K238N
- •K103T V179D G190E K238T
- •V106A V179T G190Q Y318F
- •3. Previously documented HIV-2 infection.
- •4. Subject has a positive HLA-B5701 test at screening (when the invesigator considers
- •ABC/3TC as a background regimen). In case of a positive test, ABC/3TC cannot be
- •administered, but instead, the investigator can select AZT/3TC as the background
- •regimen. HLA-B5701 testing is not required for subjects with prior documented
- •negative results.
- •5. Use of disallowed concomitant therapy from 4 weeks prior to the baseline visit.
- •6. Any condition (including but not limited to alcohol and drug use), which, in the opinion
- •of the investigator, could compromise the subject?s safety or adherence to the protocol.
- •7. Life expectancy less than 6 months.
- •Subject has any currently active Acquired Immunodeficiency Syndrome (AIDS) defining
- •illness (Category C conditions according to the Centers for Disease Control and
- •Prevention [CDC] Classification System for HIV-Infection 1993).
- •Note: An AIDS defining illness not clinically stabilized for at least 30 days will be
- •considered as clinically active.
- •Note: Primary or secondary prophylaxis for an AIDS defining illness is allowed in case
- •the medication used is not part of the disallowed medication.
- •9. Any active clinically significant disease (e.g., pancreatitis, cardiac dysfunction, active and significant psychiatric disorders, clinical suspicion of adrenal insufficiency, hepatic
- •impairment), or findings during screening or medical history that in the investigator?s
- •opinion, would compromise the outcome of the trial.
- •10. Subject has a known or suspected acute (primary) HIV-1 infection.
- •11. Any current or history of adrenal disorder.
- •12. Previously demonstrated clinically significant allergy or hypersensitivity to any of the components of the investigational medication (TMC278) or the selected NRTIs. In this
- •last case, the other N(t)RTI may be selected.
- •13. Receipt of any investigational drug or investigational vaccine within 90 days prior to the first administration of TMC278.
- •14. Pregnant or breastfeeding girl.
- •15. Heterosexually active girls of childbearing potential without the use of effective birth
- •control methods or not willing to continue practicing these birth control methods from
- •screening onwards until at least 30 days after last intake of TMC278.
- •Girls of childbearing
研究者
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