HIV clinical trials cure

A radical gene therapy to combat HIV using genetically modified cells that are resistant to the virus has been declared a success by scientists following the first clinical trial.

The treatment, which has never been tested on humans before, raised patients' defences against HIV by replacing some of their natural immune cells with GM versions.

Tests on people enrolled in the trial found that the disease-resistant cells multiplied in their bodies.

Half of patients were taken off their usual drugs for three months and scientists recorded reduced levels of the virus.

Scientists were cautious not to draw strong conclusions from the small scale trial, which was designed to assess the safety of the therapy, but the early signs have raised their hopes.

A few shots of modified immune cells, or perhaps even one large infusion, could become an alternative for HIV patients who currently face spending the rest of their lives on antiretroviral drugs. But Levine said any improvement in the patients' health would be welcome, even if the therapy had to be used alongside existing treatments.

"People diagnosed in their 20s are on antiretroviral therapy for the rest of their lives. There are side effects. People miss days. And there is drug-resistance. This is a continuing problem, " he said. "Cure is a four letter word. We don't like to use it, particularly with HIV. We are looking at improving the health and immune function of people with HIV, " he added.

The therapy mimics a rare but natural mutation that makes about 1% of the population resistant to the most common strains of HIV. To infect cells, the virus must latch on to proteins that poke up from the surfaces of the cells. But people with the mutation lack the right protein, called CCR5, so HIV cannot get inside their immune cells. The trial centred on 10 men and two women, aged 31 to 54. All were HIV positive, and had been diagnosed between three and 23 years ago.

The scientists began by collecting white blood cells from each of the HIV patients. They then used a procedure called gene editing to modify the cells, so that they carried the rare mutation that makes people resistant to HIV. Finally, they multiplied these cells in the lab and infused a batch of 10 billion back into each patient.

At the start of the trial, all of the patients were on standard antiretroviral therapy. But after infusing them with modified immune cells, six were taken off their usual drugs. As expected, the amount of HIV virus in their bodies began to rise. But as the freshly-injected immune cells multiplied and circulated, they pushed levels of the virus back down again.

HIV under microscope
LAP LAMBERT Academic Publishing The Patients Voice in HIV/AIDS Clinical Trial Participation: What motivates the willingness of HIV infected people to take part in HIV/AIDS clinical trials?
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BMC Medical Research Methodology at the 35th Annual Conference of the ..  — BMC Pediatrics
The conference will focus on issues such as design and analysis of clinical trials, methods in biostatistics and development of clinical prediction models.

Popular Q&A

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What is a clinical trial in the context of HIV/AIDS?

'Clinical trial' is often mentioned in HIV/AIDS prevention studies. You will also find mentions of terms like: clinical management of STI (sexually transmitted infecions) and HIV.

A clinical trial is a special kind of research performed to test a new or experiemental drug or therapy on a population.
In terms of HIV, to run a clinical trial, the researchers recruit a group of HIV positive patients. The researchers will randomly assign trial participants to either the experimental therapy or the gold-standard therapy as placebo (contrary to popular belief, placebo is NEVER no treatment in such trials). The randomization process of choice is called double-blind randomized trial, meaning the neither patient nor the research observer knows what the patient is taking …

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