Maraviroc in HIV Acute INfection - ND

OSPEDALE S. RAFFAELE0 个研究点开始时间: 2009年3月17日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•-symptomatic or asymptomatic patients must fulfill at least one criterium in (A) and at least one in (B). (A) Laboratory HIV confirmation -1. positive p24 antigenemia -2. detectable viral activity - HIVRNA PCR and HIV DNA PCR -3. detectable viral activity - other RNA/DNA identification methods -(B) Laboratory confirmation of acute HIV infection -1. Ab negative/low positive by 3rd generation ELISA (or later version) -2. < 3 bands on Western Blot including gp 160, gp 120 or gp 41 -3. < 2 bands in RIBA including reactivity with gp 41 -4. initiation of therapy within 72 hours of diagnosis of PHI. -Subjects must have given written informed consent and must be able to adhere to dose and visit schedules. -Female subjects of child-bearing potential must agree to use a medically accepted method of contraception. -Female subjects of child-bearing potential must have a negative serum beta-hCG pregnancy test at Screening, and a negative urine beta-HCG pregnancy test on Day 1 prior to dosing.
•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
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•-Female subjects of childbearing potential who are breatfeeding, pregnant, or planning to become pregnant. -Subjects with active opportunistic infection or malignancy. -Subjects with intercurrent illness, vaccinations, or who have used immunomodulators that could influence plasma HIV-RNA levels within the 4-week period prior the randomization. - CXCR4 or dual-mixed (CXCR4 and CCR5) tropism. - Subjects with seizure disorder requiring ongoing anti-seizure therapy or with a history of a seizure disorder who are, in the judgment of the investigator, at risk of seizures. - Subjects with known liver cirrhosis. - Subjects with any clinically significant condition or situation other than the condition being studied that, in the opinion of investigator, would interfere with the study evaluations or optimal patecipation. - Subjects with allergy/sensitivity to study drug or its excipients. - Subjects who are participating in another clinical study.

发起方

OSPEDALE S. RAFFAELE