TIPRANAVIR MONOTHERAPY IN EXPERIENCED PATIENTS WITH MULTIPLE REVERSE TRANSCRIPTASE MUTATIONS A PROOF-OF-CONCEPT STUDY - MOTO

• Conditions: INFECTION HIV; MedDRA version: 9.1Level: LLTClassification code 10020159Term: HIV carrier

• Registration Number: EUCTR2006-006247-31-IT
• Lead Sponsor: AZIENDA OSPEDALIERA OSPEDALI RIUNITI DI BERGAMO A.O. DI RILIEVO NAZIONALE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03-09
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

AGE 18 YEARS; INFORMED CONSENT SIGNED; BEING ON A CURRENTLY FAILING HAART HIV-RNA 50 COPIES/ML HAVING A GENOTYPE PERFORMED SHOWING RESISTANCE TO BOTH NRTIS AT LEAST 3 DRUGS OF THE CLASS AND NNRTIS.
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) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

CHILDBEARING OR BREASTFEEDING. WOMEN OF CHILDBEARING POTENTIAL WILL BE ASKED TO ADOPT EFFECTIVE CONTRACEPTIVE METHODS OR BEHAVIORS ; ANY MAJOR PROTEASE MUTATION. THE ONLY PRIMARY PROTEASE ADMITTED MUTATION WILL BE D30N. PATIENTS SHOWING GENETIC VARIANTS I.E. L63P WILL BE ADMITTED

Study & Design

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