An Open-Label, Randomized Study Evaluating a Switch from a Regimen of Two Nucleoside Reverse Transcriptase Inhibitors plus any Third Agent to either a Regimen of Atazanavir/Ritonavir Once Daily and Raltegravir Twice Daily or to a Regimen of Atazanavir/Ritonavir Once Daily and Tenofovir/Emtricitabine Once Daily in Virologically Suppressed HIV-1 Infected Subjects With Safety and/or Tolerability Issues on their Present Treatment Regimen (the HARNESS study). - HARNESS

• Conditions: HIV-1 infected subjects who are virologically suppressed on a regimen of 2 NRTIs plus any 3rd agent, but experience safety and/or tolerability issues to this regimen.; MedDRA version: 15.1Level: LLTClassification code 10068341Term: HIV-1 infectionSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2009-017032-41-PL
• Lead Sponsor: Bristol Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10-18
• Last Update Posted: 10 December 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1)Signed Written Informed Consent
a)Freely given informed consent must be obtained from subjects prior to clinical trial participation, including informed consent for any screening procedures conducted to establish subject eligibility for the trial.
b)A freely given PK sub-study consent form must be obtained from the subset of subjects participating in the intensive PK sub-study.
2)Target Population
a)Subjects who are on a treatment regimen consisting of 2 NRTI + any 3rd agent for at least 3 months immediately prior to screening.
b)Subjects who are virologically suppressed (HIV-1 RNA < 50 c/mL) for at least 3 months immediately prior to screening.
c)Subjects who are virologically suppressed (HIV-1 RNA < 40 c/mL, using the Abbott m2000rt® PCR assay) during screening period.
d)Subjects who are experiencing treatment related safety and/or tolerability issues to a regimen consisting of 2 NRTI + any 3rd agent.
e)Medically stable to participate in the study (as determined by subject’s physician following review of medical history, physical examination, and clinical laboratory evaluations)
3)Age and Reproductive Status
a)Men and women, 18 years of age or older (or minimum age as determined by local regulatory or as legal requirements dictate, whichever is higher).
b)Women of childbearing potential (WOCBP) and men must be using an acceptable method of contraception to avoid pregnancy throughout the study, and for up to 8 weeks after the last dose of investigational product, in such a manner that the risk of pregnancy is minimized. See Section 3.3.3 for the definition of WOCBP. Since acceptable and available methods of contraception vary among different countries, participating women may choose their preferred contraceptive method based on physician recommendations. Caution is warranted with co administration of oral contraceptives (ethinyl estradiol and norethindrone).
c)WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to the start of investigational product.
d)Women must not be breastfeeding
e)Sexually active fertile men must use effective birth control if their partners are WOCBP.

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 114
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6

Exclusion Criteria

1)History of HAART treatment regimen switch due to virological failure
2)History of genotypic resistance to any component of the study regimen (ATV, RAL, TDF/FTC).
3)History of previous exposure to ATV (with or without RTV) or RAL prior to entering the study.
4)Subjects experiencing safety and/or tolerability issues to TDF/FTC or RTV.
5)Subjects who have switched any component of their HIV ARV medication in the last 3 months immediately prior to screening or during the screening period
6)Use of medications which are contra-indicated for concurrent use with the IMP
7)Use of proton pump inhibitors (PPI) and use of H2-antagonists.
8)History of or current cardiac disease, defined by presence of
a)arrhythmias (including torsades de pointes)
b)ischemic disease
c)conduction abnormality including:
i)left bundle branch block (LBB)
ii)left anterior fascicular block (LAFB)
iii)2nd or 3rd. degree atrioventricular (AV) block
d)any cardiac abnormality deemed clinically significant by investigator.
9)The following ECG findings:
a)PR Interval > 260 msec (severe 1st. degree AV block)
b)QRS Interval > 120 msec
10)Subjects using the following:
a)class Ib antiarrhythmics: lidocaine
b)class Ic antiarrhythmics: flecainide and propafenone
c)calcium channel blocker: bepridil
11)Presence of a newly diagnosed HIV-related opportunistic infection or any medical condition requiring acute therapy at the time of screening.
12)Positive HBSAg test results. Patients who are currently receiving treatment for HCV or are planning to receive treatment for HCV in the next 6 months.
13)History or ongoing psychiatry disorder.

Study & Design

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