Abstract
BackgroundOptimal starting point for antiretroviral treatment (ART) has been uncertain.MethodsParallel group, single blind, randomised controlled study of adult HIV positive patients consulting at the Protestant Hospital, Ngaoundere, Cameroon in 2007-8. Simple randomisation of patients in WHO clinical stage 1-2 to start of ART early or deferred, i.e. when CD4 counts dropped below 350 versus 250 cells/mm3, or when they reached clinical stage 3-4. Clinical follow-up every three months were offered for all patients. Main outcomes were clinical stage, CD4 differences and mortality. Of 424 consulting patients, most were excluded, mainly because they were already in WHO stage 3-4. Forty-four patients were randomised.ResultsIn the ‘early’ group two patients died and five were lost to follow-up. In the ‘deferred’ group, six patients died and nine were lost to follow-up (Hazard ratio for death by early compared to deferred treatment 0.26, 95% confidence interval 0.05-1.29). Of the patients lost to follow-up, three patients in the ‘early’ group and four patients in the ‘deferred’ group were known to be alive when the study ended. Fourteen patients in the early group and 11 in the deferred group started ART. Twenty-two patients were evaluated clinically six to seven months after the study period was terminated. Except for one patient with AIDS, these were all still in clinical stage 1-2.ConclusionsIn our small sample, relative risk for death did not differ significantly, but deferred treatment seemed to carry no increased survival or other clinical advantage. During the study period, other studies made WHO change its guidelines to conform to our early treatment. The tendency in our study lends support to this policy.Trial registrationISRCTN22114173Electronic supplementary materialThe online version of this article (doi:10.1186/1471-2458-14-828) contains supplementary material, which is available to authorized users.
Highlights
Optimal starting point for antiretroviral treatment (ART) has been uncertain
We report results from our study, which to some extent answered the original question of when to start, and revealed some unexpected experiences
All new cases of adult treatment-naïve HIV-positive patients diagnosed between 15 March 2007 and 31 December 2008 at the Protestant Hospital in Ngaoundere, a town of 300 000 inhabitants in Northern Cameroon, were considered eligible for the study. They were randomised to initiating treatment with CD4 counts of either
Summary
Optimal starting point for antiretroviral treatment (ART) has been uncertain. With the 2010 and 2013 guidelines, WHO recommended earlier initiation of antiretroviral treatment (ART) than in previous guidelines [1]. Evidence for a beneficial effect of earlier start of treatment was shown first in Western countries [2,3,4]. Studies from African countries and Haiti have supported this [5,6,7,8]. Population effects pointed in the same direction [9,10,11]. Randomised studies are few and there has recently been a call for more research about when to start ART in Africa [12]. One reason we started our study in 2007, was precisely
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