Darunavir/ritonavir and rilpivirine in therapy-naïve patients

• Research type

  Research Study

• Full title

  A phase IV, open-label single-arm study investigating the pharmacokinetics and pharmacodynamics of the antiretroviral combination of rilpivirine and ritonavir-boosted darunavir in therapy-naive HIV-1 infected patients.

• IRAS ID

  114430

• Contact name

  Marta Boffito

• Sponsor organisation

  St Stephen’s AIDS Trust

• Eudract number

  2012-002663-10

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  For patients who are starting to take antiretroviral medication (to treat HIV) for the first time, there are now a variety of different medicines which may be taken together as a combination in order to form an effective treatment which suppresses the virus for prolonged periods of time. Currently, national guidelines recommend the use of two different drugs of one type (the nucleoside/ nucleotide reverse transcriptase inhibitors, NRTI often known as ??nukes?) with a third drug from one of two other types (either a non-nucleoside reverse transcriptase inhibitor, known as an NNRTI or ??non-nuke?, or a protease inhibitor, known as a PI) to form a treatment regime of three active drugs. In the UK and Europe, all PIs are given in combination with a small dose of a second PI, ritonavir, which has the effect of boosting the levels of the active PI in the bloodstream. We know from both research studies and patient experience in clinic that a combination of a ritonavir-boosted PI with an NNRTI achieves similar results in suppressing the HIV virus, compared to the use of either a PI or NNRTI with 2 NRTI as described above. In this study, we will observe the combination of two licensed antiretroviral medications, ritonavir-boosted darunavir (DRV/r) and rilpivirine (RPV), in suppressing virus when given to patients who are commencing treatment for HIV infection for the first time. Both of these drugs are licensed for treatment of patients with HIV in the UK and Europe, and are currently in standard clinical use. The study will monitor this treatment over the first 48 weeks. We will also examine the levels of both drugs in the bloodstream during the first 4 weeks of starting this regimen, to confirm that they remain at levels which we know to be effective against the virus.

• REC name

  London - City & East Research Ethics Committee

• REC reference

  12/LO/1532

• Date of REC Opinion

  12 Nov 2012

• REC opinion

  Further Information Favourable Opinion