Project Lead(s): Damalie Nakanjako
Previous work has shown that persistent immune activation during chronic HIV infection was associated with suboptimal CD4 recovery and poor treatment outcomes, such as post-HAART mortality and morbidity due to non-AIDS-defining illnesses.
The use of immune-modulating drugs as adjuvants to HAART (highly active antiretroviral therapy) could potentially maximize the benefits of HIV treatment.
However, there is need to test their efficacy in patients receiving HAART.
The study was a randomized, placebo-controlled, cross-over study to determine the effect of atorvastatin on the reduction of immune activation when given as adjuvant therapy among HAART-treated adults with suboptimal immune recovery, despite sustained viral suppression.
Atorvastatin is a U.S. Food & Drug Administration-licensed drug, widely used for dyslipidemias but with anti-immune activation properties.
Results demonstrated anti-immune activation properties of atorvastatin adjuvant therapy to HIV patients on HAART, which could potentially improve immune recovery and treatment outcomes. Atorvastatin downregulates inflammatory genes among HAART-treated adults.
Giving HAART plus atorvastatin (80mg daily for 12 weeks) resulted in a 28% greater reduction in CD4 T-cell activation than HAART plus placebo – a statistically significant difference.
However, as the study period was limited to 12 weeks of follow-up, this was not sufficient to measure the effect of atorvastatin on clinical outcomes. Larger trials on atorvastin among HAART-treated individuals are needed.
The next step for the project is to do a dose escalation trial to determine the optimal dosing of atorvastatin when given as long-term adjuvant therapy to antiretroviral therapy.