Designing Clinical Trials in HIV Cure Research

Now that several potential ways have been defined to eventually reach an HIV functional cure, clinicians have to design the first clinical trials able to test these hypotheses, with a balance between audacity and safety.

Despite more than 15 years of successes with antiretroviral therapy (ART), HIV remains present in hiding places called the HIV reservoirs”, which are basically cells where the virus is inactively integrated into host chromosomes.

This explain why each time ART is stopped, the infection starts again, impairing more the immune system.

Furthermore, long-term ART goes with problems of compliance, toxicity, resistance, cost and access, making life-long ART for the 34 million infected patients currently on earth an illusion.

It is therefore mandatory to investigate new ways of treating HIV to get some drug-free time. This, also called “functional HIV cure” is a situation where HIV could remain non-replicative for months without continuing ART.

At the last “International Workshop on HIV Persistence, Reservoirs and Eradication Strategies” held in December 2011, the 215 participating scientists have defined 3 new directions to be evaluated for a functional HIV cure:

- Purging the HIV reservoir by drugs like HDAC inhibitors, Interleukin-15, Bryostatin;
- Interfering with negative immune regulatory pathways by anti-PD1 antibodies;
- Making cells resistant to HIV by gene therapy.

However, all these strategies have potential risks and there might be no benefit from them for the very first patients to be included in the first trials.

How can these risks be evaluated and what risk level can be accepted? These ethical issues are part of the debate that keeps going after the workshop, during small meetings or via professional websites.

With the next “International Workshop on HIV Persistence, Reservoirs and Eradication Strategies” scheduled in Miami, Florida, 3-6 December 2013, scientists know that they have a very short window of opportunity to be able to come with fresh data in 2 years. It absolutely needs the design and launching of the new HIV cure clinical trials in the forthcoming months.

Media Contact:
Alain Lafeuillade
AVPS
1208 Avenue Colonel Picot
83056 Toulon, Var, France
Tel: 33-4-94616340