A Cochrane review included 8 randomized studies with a total of 1113 subjects with persistent viremia due to multi-drug resistant HIV. Of the seven completed RCTs (n=609), six have reported consistent virologic and immunologic patterns, and found no significant benefit in virologic response to subsequent antiretroviral therapy in the STI arm, compared to the control arm. In addition, the largest completed randomized trial reported greater numbers of clinical disease progression events and evidence of prolonged negative impact on CD4 cell counts in the STI arm.
The single RCT with divergent findings from the others (GigHAART), reporting a significant virologic and immunologic benefit due to STI, was different in prescribing a shorter STI duration and a salvage ART regimen of 8-9 drugs. There were also differences in the patient population characteristics with this study, targeting those with very advanced HIV disease.
STI as a treatment strategy in HIV-infected patients has had various aims, including allowing wild virus to re-emerge and replace the resistant mutant virus, to halt development of drug resistance and to preserve subsequent treatment options, to alleviate treatment fatigue and reduce drug-related adverse effects; and to improve quality of life.