Efficacy trials

Efficacy trials

At the time of writing, two more efficacy trials of oral PrEP are underway, with results expected in early 2011 and mid-2012.

They are:

CDC 4370: this compares tenofovir-PrEP versus placebo among 2400 HIV-negative injecting drug users (1200 per arm) in Bangkok and Rayong Province, Thailand. Results are expected in early 2011. See http://clinicaltrials.gov/ct2/show/NCT00119106?term=CDC+4370&rank= 1.

VOICE (Vaginal and Oral Interventions to Control the Epidemic, MTN 003): VOICE has been the only trial to investigate both oral and topical PrEP (i.e. a vaginal microbicide). It began recruiting 5029 female participants in South Africa, Zimbabwe, Uganda and Malawi in 2009. To begin with, there were five arms of 1000 women each:

  • daily tenofovir oral PrEP;
  • daily Truvada oral PrEP;
  • daily oral placebo;
  • daily tenofovir gel; and
  • daily gel placebo.

The tenofovir-only oral PrEP arm was dropped in September 2011, when the study’s independent Data and Safety Monitoring Board (DSMB) decided that even if the trial ran to its planned conclusion, it would be impossible to demonstrate any significant difference in effect between oral tenofovir and placebo in preventing HIV infections.

In November 2011 the two microbicide-gel arms were also stopped because the DSMB observed that the number of infections were almost identical in women using tenofovir gel (6% annual incidence) and in women using placebo gel (6.1% annual incidence). This represents a major setback for microbicide research.

As a result, only two arms of oral PrEP (Truvada and placebo) continue as previously planned. The results of VOICE are expected in 2013. See www.mtnstopshiv.org/news/studies/mtn003/backgrounder

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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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This content was checked for accuracy at the time it was written. It may have been superseded by more recent developments. NAM recommends checking whether this is the most current information when making decisions that may affect your health.

NAM’s information is intended to support, rather than replace, consultation with a healthcare professional. Talk to your doctor or another member of your healthcare team for advice tailored to your situation.