patients affected by acute HIV infection MedDRA version: 9.1 Level: LLT Classification code 10000807 Term: Acute HIV infection
Conditions
Interventions
Trade Name: CELSENTRI
Pharmaceutical Form: Tablet
INN or Proposed INN: MARAVIROC
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Concentration number: 30-
Trade Name: KALETRA
Ph
Sponsors
OSPEDALE S. RAFFAELE
Eligibility
Sex/Gender
All
Inclusion criteria
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. =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Italy
Outcome results
None listed