DART: Development of AntiRetroviral Therapy in Africa

ISRCTN13968779

The DART (Development of AntiRetroviral Therapy in Africa) trial results have now been published as an article online first December 2009 and as print in the The Lancet, Volume 375, Issue 9709, Pages 123 - 131, 9 January 2010. The article was one of eight that were nominated for The Lancet Paper of the Year 2009, and placed as runner up

Antiretroviral therapy (ART) is often managed without routine laboratory monitoring in Africa; however, the effect of this approach was unknown. DART was designed to test whether ART could be safely and effectively delivered without the need for expensive, routine laboratory tests. It was the largest clinical trial ever carried out in Africa, 3316 HIV infected symptomatic ART naïve adults took part during 2003 to 2009 across three centres in Uganda, and one in Zimbabwe.

Participants were randomly allocated to laboratory or clinical monitoring (LCM or CDM) arms. In the LCM arm, all laboratory results (haematology, biochemistry, and CD4-cell counts) were available to clinicians. In the CDM arm CD4-cell counts were not seen by clinicians however other results could be requested if clinically indicated and in the event of grade 4 toxicities.

The results show that first-line ART can be delivered safely without routine biochemistry and haematology monitoring for toxic effects. CD4-cell count monitoring has a small but significant benefit in terms of disease progression and mortality. This suggests a role for CD4-cell testing from the second year on ART to guide the switch to second-line ART and should encourage simpler, cheaper, point-of-care CD4 tests.

Laboratories will remain important for assessment of eligibility for ART, to diagnose and manage opportunistic infections, and to assess clinical toxicity and drug contraindications. As less routine tests are required, funding can be focused on drug procurement, diagnostic laboratory services, and training to ensure quality clinical monitoring. Overall DART results have major implications for ART programmes in Africa, a country where most people still cannot access treatment.

See press release ‘Thousands more could be treated for HIV in Africa if expensive routine lab tests are dropped’.

See also: Lancet comment, BBC, DART film, Independent, Aidsmap.

The DART trial main results were first presented prior to the above publication at a special session of the 5th IAS Conference on HIV Pathogenesis, Treatment and Prevention, on Tuesday 21st July 2009 in Cape Town.

See press release DART trial finds HIV therapy could be given safely without routine laboratory tests to save more lives in Africa, and personal stories from DART trial participants on the MRC website.

A short video about DART can be found on YouTube here: http://www.youtube.com/MRCcomms.