EW ERA STUDYHIV and Eradication: A multicenter, open-label, non-randomized trial to evaluate treatment with multi-drug class (MDC) HAART and its impact on the decay rate of latently infected CD4+ T cells - NEW ERA STUDY

MUC Research GmbH0 个研究点目标入组 40 人开始时间: 2009年2月9日最近更新: 2018年6月11日

试验速览

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•FOR Stratum I (PHI) only
•N=20 patients with primary HIV infection:
•?Detectable plasma viral load
•?Elisa positive or negative and Western Blot negative or positive with ? 2 bands at screening visit;
•?no primary resistance to PI´s and NRTI´s
•FOR Stratum II (CHR) only
•N= 20 patients with chronically HIN infection:
•?Chronically HIV-infected patients with a plasma VL < 50 copies/ml for >=36 months under continuous PI-based HAART (blips not allowed) and without preceding virological failure
•?Current HAART exists of 2 NRTI plus 1 PI
•FOR ALL PATIENTS
•?Age =18 years.
•?For women of reproductive potential negative serum or urine pregnancy test within 48 hours prior to initiating study medications.
•?Use of reliable method of contraception while receiving the protocol-specified treatment and for 6 weeks thereafter.
•?For males and their female sexual partners use of acceptable methods of birth control during the entire study.
•?CCR5-tropic HI-virus
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 40
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•?Evidence for drug intolerability
•?Documented HIV-1 resistance to PI and/or NRTI.
•?CD4 nadir <200/µl
•?CHR: preceding virological failure
•?History of alcohol or other substance abuse or other condition which in the opinion of the investigator would interfere with the patient compliance or safety.
•?Any of the following abnormal laboratory test results in screening:
•a.Hemoglobin < 8 mg/dL
•b.Neutrophil count < 750 cells/?L
•c.Platelet count < 50,000 cells/L
•d.AST or ALT > 5x the upper limit of normal
•?Presence of malignancy (requiring active treatment and malignancy within 5 years prior to enrolment (even if in complete remission)
•?Significant underlying disease (non-HIV) that might impinge upon disease progression or death
•?Prior use of any experimental HIV- Integrase-Inhibitor or Entry-Inhibitor.
•?Patient is pregnant or breastfeeding, or expecting to conceive (within the duration of the study). Patient is expecting to donate eggs (within the duration of the study). Patient is expecting to donate sperm (within the duration of the study).

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