Maraviroc in HIV Acute INfection - ND

• Conditions: patients affected by acute HIV infection; MedDRA version: 9.1Level: LLTClassification code 10000807Term: Acute HIV infection

• Registration Number: EUCTR2008-007004-29-IT
• Lead Sponsor: OSPEDALE S. RAFFAELE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03-17
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

-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

Exclusion Criteria

-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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: difference in mean CD4 cells between arms at 48 weeks post−randomization.;Secondary Objective: Comparison of the plasma viral load 48 weeks after initial presentation in all treated vs. untreated patients; immunological markers (i.e. polyfunctional [single IL−2 plus IL−2/IFN−gamma plus single IFN−gamma] versus single IFN−gamma CD4 T cell responses, activation markers, CCR5 density on CD4 T lymphocytes, GALT derived T Lymphocyte analysis in those patients who will accept esophageal-duodenalscopy ).;Primary end point(s): the mean change from baseline in CD4 count at Week 48.