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Main
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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. |
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Register:
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EUCTR |
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Last refreshed on:
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19 March 2012 |
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Main ID: |
EUCTR2008-006287-11-IT |
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Date of registration:
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17/03/2009 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Virologic efficacy of Maraviroc in adult naive HIV patients with HIV-RNA>= 1000 copies/ml - ND
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Scientific title:
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Virologic efficacy of Maraviroc in adult naive HIV patients with HIV-RNA>= 1000 copies/ml - ND |
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Date of first enrolment:
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20/02/2009 |
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Target sample size:
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Recruitment status: |
Authorised-recruitment may be ongoing or finished |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-006287-11 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: no
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Phase:
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Countries of recruitment
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Italy
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
- Subjects must be at least 18 years of age at the time of randomization, of either sex and of any race with CCR5-tropic HIV infection. - Cumulative lifetime antiretroviral therapy exposure of < 4 weeks and none in the 8 weeks preceding randomization. - A CD4 cell count of ≥ 100 cells/mmc at Screening. - HIV-RNA≥ 1000 copies/ml at Screening. - Platelet count must be ≥ 75000/L, hemoglobin ≥ 9 g/dL, serum creatinine < 2 mg/dL, and AST and ALT ≤ 3 x ULN at Screening. - 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) yes
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 primary resistance mutations to any of proposed components of the study arms. - 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
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Health Condition(s) or Problem(s) studied
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naive HIV affected patients
MedDRA version: 9.1
Level: LLT
Classification code 10000811
Term: Acute infection with HIV
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Intervention(s)
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Trade Name: CELSENTRI
Pharmaceutical Form: Tablet
INN or Proposed INN: MARAVIROC
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Trade Name: TRUVADA
Pharmaceutical Form: Tablet
INN or Proposed INN: EMTRICITABINA/TENOFOVIR DISOPROXIL
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Trade Name: KALETRA
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: LOPINAVIR
CAS Number: 192725-17-0
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 133-
INN or Proposed INN: RITONAVIR
CAS Number: 155213-67-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 133-
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Primary Outcome(s)
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Main Objective: To evaluate the virologic efficacy of Maraviroc (MVC) in term of decrease of HIV-DNA (proviral) and HIV-RNA plasma kinetic decay combined with Kaletra in HIV-1 infected treatment subjects.
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Primary end point(s): To evaluate the virologic efficacy of Maraviroc (MVC) in term of decrease of HIV-DNA (proviral) and HIV-RNA plasma kinetic decay combined with Kaletra in HIV-1 infected treatment subjects.
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Secondary Objective: To assess the long-term efficacy and tolerability of MVC, to assess the increase of CD4 cells and to explore the relationship of plasma drug concentrations (pharmacokinetics) to virologic response.
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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