Public area - News, events, announcments - Topic started by kevinkelleher - December 28 2009, 01:40 pm

Title: DART trial finds HIV therapy could be given safely without routine laboratory te
Post by: kevinkelleher on December 28 2009, 01:40 pm
21 July 2009

The largest clinical trial of anti-retroviral therapy (ART) for people with HIV infection ever run in Africa has found that regular laboratory tests offer little additional clinical benefit to populations when compared to careful clinical monitoring.

The results suggest that many more people with HIV in Africa could be treated for the same amount of money as is currently spent if lab tests are not routinely used to monitor the effects of ART.

The evidence from the Development of Anti-Retroviral Therapy in Africa (DART) clinical trial will be of value to low income or resource poor countries that are prioritising ART access over investment in expensive laboratory facilities.

The DART trial aimed to find out whether the lab-based strategies used to deliver ART to people with HIV infection in resource rich countries were essential in Africa, where around 4 million people still need ART urgently and resources are limited.

The DART team believes governments and policymakers, as well as people living with HIV/AIDS, can now be confident that ART can be delivered safely and effectively by trained and supervised health workers in remote communities where routine laboratory services are not available.

In all, 3,316 people who had not previously had ART took part in the DART trial. All had severe or advanced HIV infection and had been assessed for ART eligibility using clinical staging and laboratory tests including CD4 cell count (a measure of how well the body’s immune system, which is damaged by HIV, is working). The trial began six years ago when treatment for people with HIV was just starting to become more widely available in Uganda and Zimbabwe.

DART participants were randomly allocated to one of two groups. People in the first group received ART and their doctor was given the results of blood tests done every three months to check for drug side-effects and measure their CD4 cell count. People in the second group had the same ART and the same blood tests done, but their doctors did not see CD4 count results and only saw the results of safety tests if they were seriously abnormal. People in both groups received free medical care and free diagnostic tests for episodes of illness throughout the trial.

The results show that 90% of people in the first group were still alive after five years compared to 87% of people in the second group, a difference of only 3 percentage points. Over the five years data was collected, 78% of people in the first group survived and had developed no new AIDS-related illnesses, compared with 72% in the second group. These differences only became apparent from the third year of ART. The research team believes this may be a result of the participants in the lab-monitoring group switching to a different combination of ART earlier than those in the second group. No difference in the occurrence of side effects caused by ART was found between the two groups.

Irrespective of group, the survival rate in the DART trial is amongst the best reported from any trial, ART programme or study in Africa. Historical comparisons, based on data from follow-up of similar patients in Uganda who did not have access to ART make it clear that few of the DART trial participants would have been alive after five years without ART.


Abstract titles: Impact of routine laboratory monitoring over 5 years after antiretroviral therapy (ART) initiation on clinical disease progression of HIV-infected African adults: the Dart Trial final results and Cost Effectiveness Analysis of Routine Laboratory or Clinically Driven Strategy Monitoring Anti-Retroviral Therapy in Uganda and Zimbabwe.

As the DART trial centres are key centres for ART treatment, most patients are staying at the same clinical centre for their ongoing clinical care, unless for practical reasons they wish to be transferred (e.g. to a health centre nearer to where they live).

All participants will continue to receive ART free of charge and most will stay on the same regimen they were taking at the end of the study. All the information from the trial, including all their CD4 results have been summarised for each participant at the end of the trial and shared with the participants and their health carers. Some participants will have the opportunity to enrol in other ART studies if they wish to.

The main DART trial closed on 31 December 2008. Two additional sub-studies are ongoing that will continue to August/September 2009.

The Ministries of Health in Uganda and in Zimbabwe have been informed of the results and a meeting for trial participants is scheduled to be held immediately after the IAS conference.

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