CTRI/2009/091/000298已完成1 期
A Single-Arm, Open-Label, Pilot Study of the Safety and Immunogenicity of the Merck Quadrivalent Human Papillomavirus Vaccine among HIV-Positive Women in India: A Trial of AIDS Malignancy Clinical Trials ConsortiumAcronym: AMC Protocol # 054
AIDS Malignancy Clinical Trials Consortium0 个研究点目标入组 150 人开始时间: 待定最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 150
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
- •Women age 18 or older.
- •Doucmented HIV-1 infection.
- •If having a nadir CD4 level less than or equal to 350, must be on HAART for at least 6 months prior to entry.
- •If having a nadir CD4 level greater than 350, must not be on HAART at the time of study entry.
- •Karnofsky performance score greater than or equal to 70 within 45 days prior to entry.
- •Must not be pregnant at the time of enrollment and must be willing and able to practice contraception to avoid pregnancy for the one year duration of the study.
- •Must not be breastfeeding a baby during the study.
排除标准
- •Current or history of high-grade CIN or cervical cancer.
- •Use of any systemic antineoplastic or immunomodulatory treatment, systemic corticosteroids, investigational vaccines, interleukins, interferons, growth factors, or IVIG within 45 days prior to study entry.
- •NOTE: Routine standard of care, including hepatitis B, influenza, and tetanus vaccines are not excluded.
- •Active drug or alcohol use or dependence that, in the opinion of the site Investigator, would interfere with adherence to study requirements.
- •Serious illness requiring systemic treatment and/or hospitalization within 45 days prior to entry.
- •Inability to provide informed consent.
- •Allergy to yeast or any of the components of Gardasil.
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