FindTrial
Sign In

Randomized, controlled, multicentric trial to evaluate efficacy and safety of the switch from a LPV/r based therapy to an ATV/r or a NVP based treatment in association with ABC/3TC, in HIV patient with undetectable viral load

Randomized, controlled, multicentric trial to evaluate efficacy and safety of the switch from a LPV/r based therapy to an ATV/r or a NVP based treatment in association with ABC/3TC, in HIV patient with undetectable viral load

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2006-006716-30-IT
Enrollment
200
Registered
2007-02-05
Start date
2006-12-19
Completion date
Unknown
Last updated
2022-08-08

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

Conditions

HIV infection MedDRA version: 14.1 Level: PT Classification code 10020161 Term: HIV infection System Organ Class: 10021881 - Infections and infestations

Interventions

Trade Name: VIRAMUNE*60CPR 200MG Pharmaceutical Form: Tablet INN or Proposed INN: Nevirapine Concentration unit: mg milligram(s) Concentration number: 200- Trade Name: REYATAZ*60CPS 150MG Pharmaceuti

Sponsors

AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: ? Male and female subjects between 18 and 65 years of age inclusive; ? Informed consent ; ? HIV-1 infected patients ; ? Actual treatment with a first/second line HAART with LPV/r and 2 NRTI longer than 6 months; ? Viral load suppression (HIV-1 =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: ? Incapacity to give/ maintain the informed consent; ? Active opportunistic disease, neoplasm, acute viral hepatitis, IDU, alcoholism; ? Previous NNRTI treatment discontinued for virologic failure; ? Previous treatment with NVP interrupted due to intolerance and/or toxicity; ? Previous treatment with ABC interrupted due to virologic failure, intolerance and/or toxicity; ? Female patient of child bearing potential who: o Has a positive serum pregnancy test at screening or during the study, o Is breast feeding, o Is planning to become pregnant, o Is not willing to use barrier method protection

Design outcomes

Primary

MeasureTime frame
Main Objective: To compare the different incidence of virologic failure between the two groups after 12 months from randomization.;Secondary Objective: ? To evaluate after 12 months any changes of CD4+ and CD8+ (absolute value and percentage); ? To evaluate after 12 months any metabolic, morphologic lipodystrophic alteration; ? To evaluate after 12 months the alteration of the bone metabolism;Primary end point(s): ? Proportion of patients with HIV pVL <50 copies/ml in the two different groups.—

Countries

Italy

Outcome results

None listed

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