|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
EUCTR |
|
Last refreshed on:
|
19 March 2012 |
|
Main ID: |
EUCTR2008-007004-29-IT |
|
Date of registration:
|
17/03/2009 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Maraviroc in HIV Acute INfection - ND
|
|
Scientific title:
|
Maraviroc in HIV Acute INfection - ND |
|
Date of first enrolment:
|
20/02/2009 |
|
Target sample size:
|
|
|
Recruitment status: |
Authorised-recruitment may be ongoing or finished |
|
URL:
|
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-007004-29 |
|
Study type:
|
Interventional clinical trial of medicinal product |
|
Study design:
|
Controlled: no
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: no
|
|
Phase:
|
|
|
|
Countries of recruitment
|
|
Italy
| | | | | | | |
|
Contacts
|
|
Name:
|
|
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
|
|
Name:
|
|
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
| |
|
Key inclusion & exclusion 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. < 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.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
|
|
Health Condition(s) or Problem(s) studied
|
patients affected by acute HIV infection
MedDRA version: 9.1
Level: LLT
Classification code 10000807
Term: Acute HIV infection
|
|
Intervention(s)
|
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
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: LOPINAVIR
CAS Number: 192725-17-0
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Concentration number: 250-
INN or Proposed INN: RITONAVIR
CAS Number: 155213-67-5
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Concentration number: 250-
Trade Name: TRUVADA
Pharmaceutical Form: Tablet
INN or Proposed INN: EMTRICITABINA/TENOFOVIR DISOPROXIL
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 445-
Trade Name: SUSTIVA
Pharmaceutical Form: Tablet
INN or Proposed INN: Efavirenz
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 600-
|
|
Primary Outcome(s)
|
|
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 ).
|
|
Main Objective: difference in mean CD4 cells between arms at 48 weeks post−randomization.
|
|
Primary end point(s): the mean change from baseline in CD4 count at Week 48.
|
|
Source(s) of Monetary Support
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|