PROBE TRIAL proof-of-concept study on the use of rilpivirine as substitutive agent for the HAART nucleosidic backbone in virologic suppressed patients

• Conditions: HIV1-infected adults; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2013-002573-22-IT
• Lead Sponsor: A.O PAPA GIOVANNI XXIII- BERGAMO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06-20
• Last Update Posted: 10 February 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

HIV-1 documented infection
Age = 18 years
Being on a stable HAART regimen based on the association of 2 NRTIs and a boostd-PI for at least 6 months.
Being on an effective (VL < 50 copies/ml) HAART regimen. Two consecutive HIV-RNA determination below the determination threshold before enrollment are required
No known allergy to NNRTIs
Women of childbearing potential will be asked to adopt an effective birth control system throughout the study period
Informed consent signed

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 60
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Any major NNRTI or PI resistance mutation in an historical genotype
Pregnancy or breast-feeding
An active malignancy or OI requiring active treatment (prophylactic regimens are allowed)
Life expectancy < 18 months

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified