Please login to the form below

Not currently logged in
Email:
Password:

Merck ends HIV drug study

Merck is to end its study investigating once-daily Isentress for patients with HIV-1 after it failed to improve on a twice-daily version

Merck is to end its study investigating once-daily Isentress (raltegravir) for patients with HIV-1 after the drug failed to improve on an already approved twice-daily version in a phase III trial.

The trial evaluated the safety and efficacy of an investigational once-daily 800mg dose of the drug against the approved twice-daily 400mg dose, each in combination with a once-daily dose of emtricitabine and tenofovir disoproxil fumarate, in adult treatment-naïve HIV-1-infected patients.

Of the patients taking the once-daily does, 83.2 per cent achieved undetectable viral levels, compared to 88.9 per cent of patients in the twice-daily group. This difference, however, did not meet the pre-defined statistical criteria for non-inferiority.

Drug safety was found to be similar in both regimens, and consistent with current labelling for Isentress.

The 400mg version of the drug is currently the only approved integrase inhibitor for the treatment of HIV-1. It works by inhibiting the insertion of HIV-1 DNA into human DNA by the integrase enzyme.

Merck said it is notifying clinical investigators of the decision to cancel the trial this week, with a recommendation that patients enrolled in the once-daily dosing arm of the study be switched to Isentress twice daily.

30th November 2010

Share

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
Syneos Health™

Syneos Health™ is the only fully integrated biopharmaceutical solutions organization. Our company, including a Contract Research Organization (CRO) and Contract...

Latest intelligence

PM Society Digital Awards – the power of together
Our chief executive, Emma Statham, writes about the value of awards and the power of together....
Seduction_feature_image_thumb.jpg
Seduce anyone in four simple steps
You know the health of the global economy is dependent on our ability to seduce one another – don’t you? And you know that we need to be able to...
What Would Jeremy Do? : Assessing the impact of a Corbyn-led Labour government
GK Strategy are delighted to announce the launch our latest briefing paper entitled ‘What Would Jeremy Do? Assessing the impact of a Corbyn-led Labour government’....

Infographics