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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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2008-002978-35-IT
Enrollment
Unknown
Registered
2008-07-24
Start date
2008-07-24
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

First line therapy of HIV-1-infected patients. MedDRA version: 9.1 Level: LLT Classification code 10020441 Term: Human immunodeficiency virus infection, unspecified

Interventions

Product Name: MARAVIROC Pharmaceutical Form: Tablet INN or Proposed INN: MARAVIROC Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150-

Sponsors

AZIENDA OSPEDALIERA L. SACCO (A.O. DI RILIEVO NAZIONALE)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria: Pregnant or breastfeeding women; patients who are not capable to the trial participation according to the judgement of the PI.

Design outcomes

Primary

MeasureTime frame
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.—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026