PER-007-08未知未知
The Effect of Prior Short Course Combination Antiretroviral Therapy Administered for the Prevention of Mother-to-Child Transmission (pMTCT) of HIV-1 on Subsequent Treatment Efficacy in Treatment-Nearly Naive Participants
INSTITUTO NACIONAL DE ALERGIAS Y ENFERMEDADES INFECCIOSAS DE LOS ESTADOS UNIDOS,0 个研究点目标入组 0 人开始时间: 2008年5月26日最近更新:
适应症
试验速览
- 阶段
- 未知
- 发起方
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
- 年龄范围
- 0 至 0（—）
入选标准
- •HIV-1 infection. documented by an officially authorized HIV ELISA Test and confirmed by a Western Blot at some time prior to the start of the study. Culture of HIV, HIV-1 antigen, HIV-1 plasma RNA or a second antibody test by a method other than ELISA is accepted as an alternative confirmatory test.
- •ViH-1 plasmatic RNA of ^ 500 copies / mL measured with the Roche UltraLensensitive Roche Amplicor Monitor assay (Roche Molecular Systems) and performed within 90 days prior to patient admission in an approved DAIDS laboratory.
- •Women> 16 years old.
- •Previous history of ART in combination for> 7 days during at least one pregnancy for HIV pMTCT.
- •ART history only for the purpose of pMTCT for a maximum of 40 weeks during pregnancy and 12 weeks postpartum for each pregnancy and with an interval between pregnancies of at least 24 weeks without treatment.
- •Clinical or laboratory indication (such as drop in CD4 + count) to initiate ART in the opinion of the participant´s health care provider.
- •Successful genotyping of the screening plasma sample within 90 days prior to study entry.
- •Potentially fertile women participants, defined as girls who have reached menarche, women who are not post-menopausal for at least 24 months, or have not undergone a surgical sterilization procedure (hysterectomy or bilateral oophorectomy, or bilateral salpogectomy or ligature tubaria) must have a negative serum or urine pregnancy test done within 2 days before entering the study.
- •Ability and availability on the part of the candidate or legal representative / guardian to sign the Informed Consent form.
排除标准
- •Have received an ARV in the 24 weeks prior to the start of the study.
- •Evidence of any of the mutations for HIV-1 RT within 90 days prior to the start of the study [36]: NNRTI-associated mutations: LOOOO, K103N, V106A / M, V108I, Y181C / 1, Y188C / H / L, G190A / S, P225H, P236L Mutations associated with NRTi: M41L, K65R. D67N, insertion complex 69, K70R, L74V, Q151M, M184V, L210W, T215A / C / D / E / F / G / H / 1 / L / N / SA // Y, K219Q / E, Y115F.
- •Evidence of any of the mutations listed in 4.2.2 in a standard viral resistance test for majority populations obtained at any time before the start of the study (if available).
- •Treatment for pMTCT with sd-NVP, inclusion of NVP as a simple agent in a regimen that is failing or adding some component of the regimen used in A5227 as a simple agent to a regimen that is failing. Failure is defined as an increase in viral load above> 0.5 log10 of baseline or loss of suppression (> 200 copies / mL) of plasma HIV-1 RNA.
- •Treatment within 14 days prior to the start of the study
- •Use of vaccines for HIV, chronic systemic corticosteroids, interleukins, interferon, other cytokines or research therapies within 30 days prior to the start of the study.
- •Acute therapy for serious medical conditions (in the opinion of the investigator) within 14 days prior to the start of the study unless the study participant has completed 7 days of therapy and is clinically stable.
- •Any condition which, in the opinion of the researcher, may compromise the participant´s ability to participate in the study.
- •Malignities that require systemic chemotherapy.
- •Allergy / known sensitivity to one or the study drugs or their formulations.
- •Pregnancy and lactation.
- •Use of drugs or alcohol that, in the opinion of the investigator, could interfere with the adherence to the requirements of the study.
- •Documentation of 2 VlH-1 RNAs> 5,000 consecutive copies / mL 8 weeks or more after initiating ART during pregnancy and while receiving ART.
- •Documentation of 2 HIV-1 RNAs> 400 consecutive copies / mL 24 weeks or more after initiating ART during pregnancy and while receiving ART.
- •Current incarceration or placement in a medical center due to psychiatric or physical illness (eg, infectious disease).
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