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Clinical trials news

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My transition toward trans awareness

I recall when a colleague told me in 2014 that some transgender women advocates were unhappy with iPrEx. I was surprised and disappointed.

Published
08 September 2016
From
Robert Grant (blog)
Realism needed about the benefits and risks of taking part in HIV cure studies

A significant proportion of people living with HIV would be willing to take part in a study towards a cure for HIV, research presented at the 21st International

Published
31 August 2016
By
Roger Pebody
German agency criticises European programme for speeding some drug approvals

In pointed remarks, Germany’s cost-effectiveness watchdog has criticised an effort by European regulators to accelerate approval for new medicines by limiting its requirements for evidence. The concerns raised by the agency come as regulators on both side of the Atlantic increasingly look to such approaches to get new drugs to patients with unmet medical needs. At issue is a proposal called adaptive pathways, a term used to describe a method for jumpstarting drug approvals for select patient populations. Two years ago,an EMA pilot programme was launched to compare initial data used for approval with so-called “real world” data, which is subsequently gathered after the medicines are in use.

Published
18 August 2016
From
STAT
People At High Risk Of HIV Are Having The HIV Prevention Pill Taken From Them

Exclusive: The NHS is stopping participants in a major study into the drug Truvada from having further access to it – a move which Britain’s biggest HIV charity said would lead some to become infected.

Published
29 July 2016
From
Buzzfeed
It’s all go for a new HIV vaccine efficacy trial this year

A new efficacy trial for a vaccine to prevent HIV infection – only the seventh ever conducted in the history of the epidemic – will start

Published
19 July 2016
By
Gus Cairns
Fast Advance in Hepatitis C Care Prompts EMA to Revise Clinical Trial Guideline

EMA has proposed changes to its guideline on clinical trials of direct acting antiviral hepatitis C drugs. The revisions are intended to ensure the guideline reflects the dramatic changes that have happened in the hepatitis C sector since Gilead introduced its blockbuster Sovaldi (sofosbuvir).

Published
17 July 2016
From
Regulatory Affairs Professionals Society
Large-Scale HIV Vaccine Trial to Launch in South Africa

The US National Institute of Allergy and Infectious Diseases (NIAID) and its partners have decided to advance an experimental HIV vaccine regimen into a large clinical trial, the first for seven years. This new study, called HVTN 702, is designed to determine whether the vaccine is safe, tolerable and effective at preventing HIV infection among South African adults. The trial will begin in November 2016, pending regulatory approval. It will recruit 5400 HIV-uninfected men and women aged 18 to 35 years who are at risk for HIV infection.

Published
18 May 2016
From
National Institute of Allergy and Infectious Diseases
Do ethicists hinder HIV prevention research?

Ethics panels may be hindering HIV prevention efforts by requiring gay and bisexual adolescents to get parental consent before taking part in research, experts suggest.

Published
21 April 2016
From
Reuters
Maraviroc may work as PrEP in combination with another drug – but probably not by itself

Two studies presented at the Conference on Retroviruses and Opportunistic Infections (CROI 2016) outlined the first findings from the NEXT-PrEP study, otherwise known as HPTN 069.

Published
03 March 2016
By
Gus Cairns
‘On-demand’ rectal microbicide gel has reasonable tolerability and acceptability – daily less so

Results from the MTN-017 study of 1% tenofovir gel as a rectal microbicide were presented to the Conference on Retroviruses and Opportunistic Infections (CROI 2016) on

Published
28 February 2016
By
Gus Cairns
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Community Consensus Statement on Access to HIV Treatment and its Use for Prevention

Together, we can make it happen

We can end HIV soon if people have equal access to HIV drugs as treatment and as PrEP, and have free choice over whether to take them.

Launched today, the Community Consensus Statement is a basic set of principles aimed at making sure that happens.

The Community Consensus Statement is a joint initiative of AVAC, EATG, MSMGF, GNP+, HIV i-Base, the International HIV/AIDS Alliance, ITPC and NAM/aidsmap
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