Intensification of HAART with Maraviroc (MVC) as first line therapy of HIV-1-infected patients to rapidly suppress viral replication and minimize the evolution of drug-resistant variants - ND
- Conditions
- First line therapy of HIV-1-infected patients.MedDRA version: 9.1Level: LLTClassification code 10020441Term: Human immunodeficiency virus infection, unspecified
- Registration Number
- EUCTR2008-002978-35-IT
- Lead Sponsor
- AZIENDA OSPEDALIERA L. SACCO (A.O. DI RILIEVO NAZIONALE)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Aged > o = 18 yrs;
HAART naive;
CD4 ≥ 350 cells/uL;
HIV-1 RNA ≥ 50000 copies/mL;
CCR5-tropic isolate determined by the Trofile test;
absence of pharmacological resistance to ARV drugs.
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
Pregnant or breastfeeding women;
patients who are not capable to the trial participation according to the judgement of the PI.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Study viral suppression and resistance emergence in 10 naïve patients with a CD4 count ≥ 350 cells/uL and HIV-1 RNA ≥ 4.69 log on HAART intensification with MVC compared to 10 patients with analogous characteristics on the same background HAART.;Secondary Objective: ;Primary end point(s): Differences in HIV evaluation between the 2 study groups.
- Secondary Outcome Measures
Name Time Method