HIV i-Base

Current UK studies (selected)

The following studies are a few of those currently running in the UK. This listing is mainly for independent research studies rather than studies run by pharmaceutical companies.

Information may change as study enrolment status changes. There in no online resource that this all HIV-related studies in the UK. It is also disappointing that there is no requirement for researchers to list publicly their ongoing studies.

Research centres are encouraged to contact i-Base to list ongoing trials on these pages.

Ongoing studies currently enrolling

  • Heather Study – HIV treatment in primary HIV infection.

Study that plans to enrol people in the UK who start HIV treatment with 6 months of their infection. The study is being run as part of the Cherub network. For details email Dr Sarah Fidler or Dr Julie Fox.

The PARTNER study looks at the risk of sexual HIV transmission between partners where one person is HIV positive and using HIV treatment and the other partner is HIV negative. The study also looks at why some couples do not always use condoms.

First results from the PARTNER study reported no linked HIV transmissions after 44,500 potential exposures not using condoms. PARTNER2 extends the original study to enrol an additional 450 gay male couples. Link to study website.

A study looking at the risks and benefits of starting antiretroviral HIV treatment at any CD4 count above 500 compared to starting when the CD4 count is 350. By January 2014, the study was fully enrolled with more than 4600 participants. First unblinded results are due at the end of 2016.

This is a two year study to prevent HIV transmission by taking a daily pill. The strategy is called PrEP and 545 HIV negative men were randomised to either start PrEP immediately or to start after the first year. In October 2014, the study design was changed to offer all participants immediate PrEP. This was because of early results showing the PrEP was very effective. PROUD is also now enrolled and next results are expected later in February 2015, with the full study continuing for another year. Link to study website.

This important study on HIV and ageing is recruiting people from three different groups: HIV positive people older than 50, HIV positive people younger than 50 and HIV negative people older than 50. This is an observational cohort study which means that the aim is mainly to collect information which is then analysed to compare difference between these group.

This pilot study is looking at whether different doses of telmisartan can reduce the risk of developing insulin resistance. Telmisartan is commonly prescribed to lower blood pressure. It can also improve insulin sensitivity which may help reduce the risk of developing diabetes or heart disease.

Other HIV studies with telmisartan have looked at whether it can help reduce abdominal fat associated with lipodystrophy.

A UK study looking at whether there are any neurological differences (ie in brain function) in people starting one of two different combinations.

SCART is a UK study for HIV-related Kaposi’s Sarcoma (KS). It uses an experimental cancer drug called selumetinib. KS is a type of cancer that is more common in HIV positive people although it is much less common now that HIV treatment is available. This study is for people who are already on HIV antiretroviral treatment.

Other ongoing UK studies

The following studies are listed on the US-based database clinicaltrials.org. This site include the option to search for ongoing studies using both HIV and UK in the search field.

The European Union trials register is at www.clinicaltrialsregister.eu. A smaller European trial database is at www.controlled-trials.com and a UK trial register is at http://public.ukcrn.org.uk. These also allow searching for HIV and other key words.

Rilpivirine plus darunavir/ritonavir in treatment naive patients
http://clinicaltrials.gov/ct2/show/NCT01736761 

Adding maraviroc to darunavir/ritonavir monotherapy (CINAMMON Study)
http://clinicaltrials.gov/ct2/show/NCT01680536

This study is looking are whether there are any differences in neurological (brain) function from adding maraviroc to darunavir/ritonavir monotherapy.

Cohort studies

Cohort studies use anonymised information from large databases to answer questions that need many thousands of people. Sometimes they can focus of safety issues for rare events. Sometimes they can see how well treatment is working in large groups of people. Sometimes they can highlight whether guidelines are being followed – for example at which CD4 count people start treatment.

Because personal information is removed from the data, many of these studies do not need participants to consent to being in the study. Many people in the UK may already be contributing to this important research without realising it.

The following cohort studies all include HIV positive people from the UK.

UK COHORTS

The database hold information from over 40,000 people with HIV who have attended care since 1996. The data collected includes. It also looks at the impact of co-infection with HCV and/or HBV. Other upcoming studies include HIV and ageing looking at the implications of an ageing HIV population.

The UK HIV Drug Resistance Database is a collect results from resistance tests performed as part of routine clinical care throughout the UK. By the end of 2010, it included over 75,000 test results. This important study also provides information about trends in transmitted drug resistance and how resistance is changing over time.

The NSHPC is the confidential national active reporting scheme for pregnancies in HIV positive women, babies born to HIV positive women and other children living with HIV. It covers over 245 clinics. Between 1989 and the end of June 2011, in included 14571 pregnancies; 287 of these were from before 1989 (including those who were born abroad and came to the UK and Ireland later).

CHIPS is a collaboration between clinical centres that care for HIV positive children. By the end of March 2011 the database has 1699 children, all children receiving HIV-related care from 2006 onwards. 1190 were alive and in active follow-up at a CHIPS clinic, and 305 had transferred to adult care. CHIPS works with the UK Register of HIV Seroconverters to ensure continued follow-up of young people as they transfer to adult care when they turn 16 if they give consent.  This will provide critical data on the long-term consequences of HIV and ART in adulthood.

SOPHID collects the number of persons receiving HIV-related treatment or care, is the national HIV census of HIV infection. These national and local data help inform HIV prevention strategies, estimate the overall HIV prevalence in the UK and allocate funding for HIV treatment and prevention.

This is an observational database of adults who are diagnosed within a year of their likely time of HIV infection. This is categorised by having a previous HIV negative test within the last year, showing a recent infection using the RITA/STARHS test, or having a positive viral load with an negative HIV antibody test. The cohort also include children who were born with HIV, as their infection date is known.

The CD4 surveillance scheme monitors immune suppression (suppression of the immune system and its ability to fight infection) among HIV positive adults.  The timing of first CD4 count indicates how quickly patients are integrated in HIV care following diagnosis.  Similarly, monitoring the proportion of patients with CD4 under 350 receive ART demonstrates the extent to which patients receiving treatment according to national guidelines.

The Health Protection Agency has developed a new dataset, the HIV and AIDS Reporting System (HARS). This system will eventually replace SOPHID and new HIV diagnoses.

The MHRA is responsible for the regulation of medicines and medical devices and equipment used in healthcare and the investigation of harmful incidents. The MHRA also looks after blood and blood products, working with UK blood services, healthcare providers, and other relevant organisations to improve blood quality and safety.

European cohorts

This study is a collaboration that combines data from 19 cohort studies from Europe and North America. This gives the opportunity to look at questions involves over 70,000 HIV positive people.

CASCADE includes data from more than 25,000 people who were diagnosed in very early infection from 28 cohorts in Europe (including the UK), Australia and sub-Saharan Africa. Monitoring seroconverters and those already enrolled in studies, covering the entire duration of HIV infection.

PENTA is the foundation for the treatment and care of children with HIV and serves as an umbrella for the network. PENTA is an integrated programme of clinical trials and observational studies among HIV-positive pregnant women and children.

The D:A:D study is the largest study set up to specifically look at potential long-term side effects of ART. It was one of the first studies to look at lipodystrophy and then focused on heart disease. In 2008 the study approved proposals to include new additional endpoints – non-AIDS defining cancers, end-stage renal disease, and chronic liver disease. The study is now embarking in its 13th year and is projected to continue at least until 2017.

The EuroSIDA study is a prospective observational cohort study of more than 18,000 patients followed in 108 hospitals in 34 European countries plus Israel and Argentina. The main aim of the study is to assess the impact of antiretroviral drugs o­n the outcome of the general population of HIV positive people in Europe.

EuroCoord is a European network of cohort studies coordinating clinical research on HIV/AIDS at European and International levels. It is an initiative of the CASCADE, COHERE, EuroSIDA and PENTA projects. It is a large, integrated network that aims to exploit the scientific strengths of each collaboration to ensure that the best, most competitive observational HIV research is performed. EuroCoord includes data from over 250,000 HIV positive people from many different settings in Europe and beyond.

USA COHORTS

Although the following cohorts do not include HIV positive people from the UK they provide important study results because many of them also include HIV negative people as comparisons. These include WIHS (a large women’s cohort), MACS (a large men’s cohort), VACS (Veterans Ageing Cohort Study) and NA-ACCORD.

Studies for HIV negative people (HIV vaccines etc)

If you are HIV negative and want to participate in research see the MRC Help Make History website for further details.

Previous listed studies with reported results

A study to see whether an anti-malarial drug called hydroxychloroquine can reduce immune activation in people not yet using HIV treatment. The researchers hope that this could benefit the immune system. NOTE: At the IAS conference in Rome in July 2011 results showed that HCQ had no benefit and actually produced a slight drop in CD4 count. Study results link.

A study looking at using boosted-protease inhibitor as a single drug maintenance treatment compared to a three-drug combination. This five-year study presented early results at CROI 2014 and the BHIVA 2014 conference.