A Phase 3 Randomized, Open Label Study to Evaluate Switching from Regimens Consisting of a Ritonavir-boosted Protease Inhibitor and Two Nucleoside Reverse Transcriptase Inhibitors to Emtricitabine/Rilpivirine/ Tenofovir Disoproxil Fumarate (FTC/RPV/TDF) Fixed-dose Regimen in Virologically Suppressed, HIV-1 Infected Patients - ND

• Conditions: Human Immunodeficiency Virus (typeI) Infection; MedDRA version: 9.1Level: LLTClassification code 10020192

• Registration Number: EUCTR2010-023178-37-IT
• Lead Sponsor: Gilead Sciences Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12-27
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 420

Inclusion Criteria

HIV-infected patients matching the following criteria: •Currently receiving antiretroviral therapy with a ritonavir-boosted PI and two NRTIs continuously for =6 months preceding the screening visit; •Have plasma HIV-1 RNA concentrations (at least two measurements) at undetectable levels (according to the local assay being used) for =6 months prior to the screening visit and have HIV RNA <50 copies/mL at the screening visit; •Be on their first or second antiretroviral drug regimen; if on their second regimen, must not have had HIV-1 RNA >50 copies/mL at the time of the change in antiretroviral drugs, nor ever experienced two consecutive HIV RNA >50 copies/mL after first achieving HIV RNA < 50 copies/mL; •Adequate renal function: Estimated glomerular filtration rate =70 mL/min according to the Cockcroft Gault formula; •No previous use of any approved or experimental non-nucleoside reverse transcriptase inhibitor (NNRTI) drug for any length of time; •Hepatic transaminases (AST and ALT) =5 x upper limit of normal (ULN; •Have a genotype prior to starting initial antiretroviral therapy and have no known resistance to any of the study agents at any time in the past including, but not limited to the RT resistance mutations K65R, K101E/P, E138G/K/R/Q, Y181C/I/V, M184V/I, or H221Y; . No proven or suspected acute hepatitis in the 30 days prior to study entry; . No anticipated need to initiate drugs during the study that are contraindicated.
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

• A new AIDS defining condition diagnosed within the 30 days prior to screening (except CD4 cell count and/or percentage criteria) (refer to Appendix 5) • Females who are breastfeeding • Positive serum pregnancy test (female of childbearing potential) • Current alcohol or substance abuse judged by the Investigator to potentially interfere with subject compliance. • A history of malignancy within the past 5 years (prior to screening) or ongoing malignancy other than cutaneous Kaposi`s sarcoma (KS), basal cell carcinoma, or resected, non-invasive cutaneous squamous carcinoma.

Study & Design

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