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DART trial finds HIV therapy could be given safely without routine laboratory tests to save more lives in Africa

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.