A randomised, controlled, open-label trial to compare the efficacy, safety and tolerability of a treatment simplification by darunavir/ritonavir (DRV/r) 800/100 mg O.D. versus a triple combination therapy containing DRV/r in HIV-1 infected subjects with undetectable plasma HIV-1 RNA on their current treatments.

Janssen-Cilag International NV0 sites250 target enrollmentMarch 15, 2007

Overview

No summary available.

Registry

who.int

Start Date

March 15, 2007

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•Subjects who meet all of the following criteria are eligible for this trial:
•Subjects with documented HIV\-1 infection.
•Male or female ages \> 18 years old.
•Subjects who have voluntarily signed and dated the consent form.
•Subjects currently receiving HAART for at least 24 weeks.
•Note: HAART is defined as the combination of 2 NRTIs with at least 1 additional ARV from the NNRTI and/or PI class. A regimen with 3 NRTIs is allowed.
•Plasma HIV\-1 RNA \< 50 copies/mL for at least 24 weeks prior to screening (two results must be documented).
•Subjects taking the same ARV combination for at least 8 weeks before screening.
•Subject and physician’s preference to change the current HAART regimen for reasons of simplification and/or toxicity (examples of toxicities include but are not limited to: CNS, gastrointestinal disturbances, jaundice, anaemia, nausea, neuropathy, paresthesia, hyperlipidaemia, glucose intolerance or diabetes, nephrolithiasis, lipodystrophy, hepatotoxicity, rash and skin related events, any other AE or intolerability or laboratory abnormalities caused by current HAART).
•CD4 \> 100/mm(3\) at the start of HAART and \> 200/mm(3\) at screening.

•Subjects meeting one or more of the following criteria cannot be selected for this trial:·
•History of virological failure defined as two consecutive plasma HIV\-1 RNA \> 500
•copies/mL while on previous or current antiretroviral therapy.
•History of any primary PI mutations as defined by the IAS\-USA guidelines 2006\.
•Clinical or laboratory evidence of significantly decreased hepatic function or decompensation, irrespective of liver enzyme levels (liver insufficiency).
•Subjects diagnosed with acute viral hepatitis at screening.
•Subjects co\-infected with hepatitis B.
•Note: Subects co\-infected with hepatitis B are disallowed to avoid a flare\-up when discontinuing NRTIs. Subjects co\-infected with chronic hepatitis C will be allowed to enter the trial if their condition is clinically stable and is not expected to require treatment during the study period. See section 9\.3\.3\.3\. of the protocol for further guidelines on enrolment of hepatitis C co\-infected subjects.
•Subjects with a grade 3 or 4 laboratory abnormality as defined by DAIDS grading table (see addendum 1 of the protocol: DAIDS AE grading Table), with the following exceptions unless clinical assessment foresees an immediate health risk to the subject:
•\-Subjects with pre\-existing diabetes or with asymptomatic glucose grade 3 or 4 elevations.