PER-092-20招募中1 期
ANTIRETROVIRAL ANALYTICAL TREATMENT INTERRUPTION (ATI) TO ASSESS IMMUNOLOGIC AND VIROLOGIC RESPONSES IN PARTICIPANTS WHO RECEIVED VRC01 OR PLACEBO AND BECAME HIV-INFECTED DURING HVTN 704/HPTN 085
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: 2021年2月3日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 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
入选标准
- •1. Estimated date of HIV-1 acquisition within 8 weeks of participant’s last HVTN 704/HPTN 085 infusion.
- •2. Initiated ART within 28 weeks of HVTN 704/HPTN 085 HIV-1 date of diagnosis.
- •3. Receiving continuous ART for at least 1 year
- •4. If on an NNRTI, willingness and ability to switch to a PI- or INSTI-containing regimen for at least 4 weeks prior to ART interruption.
- •5. Willingness to interrupt ART for up to 24 weeks or up to the time of meeting ART re-initiation criteria.
- •6. Willingness to re-initiate ART upon meeting study ART re-initiation criteria.
- •7. Willingness to use barrier protection (ie, male or female condoms) for all sexual activity until after confirmation of viral suppression following ART reinitiation
- •8. Willingness for CRS staff to contact primary HIV care provider to exchange information regarding HVTN 804/HPTN 095 and participant medical history.
- •9. Site investigator anticipates that a fully active alternative ART regimen could be constructed and would be available in the event of virologic failure on the participant’s current ART regimen.
- •10. Access to a participating CRS and willingness to adhere to study visit schedule and to be followed for the planned duration of the study.
- •11. Ability and willingness to provide informed consent.
- •12. Assessment of understanding: volunteer demonstrates understanding of this study; completes a questionnaire prior to enrollment with verbal demonstration of understanding of all questionnaire items answered incorrectly.
- •13. Agrees not to enroll in another study of an investigational research agent for the duration of the participant’s trial participation.
- •14. HIV-1 infection, with reactive HIV-1 antibody and any Multispot or Geenius HIV-1/HIV-2 results, documented by the HVTN 704/HPTN 085 HIV diagnostic algorithm.
- •15. Plasma HIV-1 RNA ≥ 1,000 copies/mL by any assay, prior to initiating ART.
- •16. CD4+ cell count ≥ 450 cells/mm3 obtained within 90 days prior to enrollment.
- •17. One plasma HIV-1 RNA below the lower limit of quantitation (LLOQ) collected at each of the following:
- •Note:Non-US sites must have results from locally available assays that are approved as standard-of-care by their regional governing bodies.
- •18. Hemoglobin (Hgb) ≥ 10.0 g/dL for volunteers who were assigned female sex at birth, ≥ 11.0 g/dL for volunteers who were assigned male sex at birth.
- •19. Absolute neutrophil count (ANC) ≥ 750 cells/mm3
- •20. Platelets ≥ 100,000 cells/mm3
- •21. ALT < 2.5 times the institutional upper limit of normal and direct bilirubin within the institutional range of normal.
- •22. Estimated glomerular filtration rate (eGFR) > 60 mL/min/1.73m2.
- •23. Volunteers capable of becoming pregnant: negative serum or urine beta human chorionic gonadotropin (β-HCG) pregnancy test performed at the screening visit and prior to enrollment. Persons who are NOT capable of becoming pregnant due to having reached menopause (no menses for 1 year) or having undergone total hysterectomy or bilateral oophorectomy or tubal ligation (verified by medical records) are not required to undergo pregnancy testing.
- •24. Reproductive status: A volunteer who is capable of becoming pregnant must agree to consistently use effective contraception (see Appendix B and HVTN 804/HPTN 095 SSP) for sexual activity that could lead to pregnancy from at least 21 days prior to enrollment through confirmation
排除标准
- •1. Any plasma HIV-1 RNA ≥ LLOQ (LLOQ: 75, 50, 40, or 20 copies/mL) within 12 months prior to enrollment.
- •Note: Non-US sites must have results from locally available assays that are approved as standard-of-care by their regional governing bodies.
- •2. History of AIDS-defining illnesses or US Centers for Disease Control (CDC) Category C events per the current list on the CDC website (see HVTN 804/HPTN 095 SSP).
- •3. Autoimmune disease, including Type I diabetes mellitus.
- •4. Immunosuppressive medications received within 6 months before enrollment.
- •5. Blood products received within 120 days before planned ART interruption.
- •6. Investigational research agents, other than experimental vaccine(s), received within 30 days before planned ART interruption.
- •7. HIV or non-HIV experimental vaccine(s) received within the last 1 year.
- •8. Licensed live attenuated vaccines received within 30 days before planned ART interruption (eg, measles, mumps, and rubella [MMR]; oral polio vaccine [OPV]; varicella; yellow fever; live attenuated influenza vaccine).
- •9. Licensed vaccines that are not live attenuated vaccines received within 14 days before planned ART interruption (eg, tetanus, pneumococcal, hepatitis A or B).
- •10. Significant or unstable cardiac or cerebrovascular disease (eg, angina, congestive heart failure [CHF], recent cerebrovascular accident [CVA], or myocardial infarction [MI]).
- •11. Hepatitis B surface antigen (HBsAg) or positive HCV RNA (Not exclusionary: positive HCV Ab with negative HCV RNA).
- •12. Pregnant or breastfeeding
- •13. Clinically significant medical condition, physical examination findings, clinically significant abnormal laboratory results, or past medical history with clinically significant implications for current health. A clinically significant condition or process includes but is not limited to: • A process that would affect the immune response; • A process that would require medication that affects the immune response; • Any contraindication to repeated blood draws, including inability to establish venous access; • A condition that requires active medical intervention or monitoring to avert grave danger to the volunteer’s health or well-being during the study period; or • Any condition specifically mentioned among the exclusion criteria.
- •14. Any medical, psychiatric, occupational, or other condition that, in the judgment of the investigator, would interfere with, or serve as a contraindication to, protocol adherence, assessment of safety, or a volunteer’s ability to give informed consent.
- •15. Any medical, psychiatric, occupational, or other condition that, in the judgment of the investigator, could be exacerbated by events associated with protocol participation, which include: ATI, low-level viremia, subsequent viral rebound, and ART re-initiation.
- •16. HIV dementia or other neurologic disease that, in the judgment of the investigator, would be a contraindication to study participation.
- •17. Psychiatric condition that precludes compliance with the protocol. Specifically excluded are persons with psychoses within the past 3 years, ongoing risk for suicide, or history of suicide attempt or gesture within the past 3 years.
- •18. Malignancy (Not excluded from participation: Volunteer who has had malignancy excised surgically and who, in the investigator’s judgment, has a reasonable assurance of sustained cure, or who is unlikely to experience recurrence of mal
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