About The Study
LiGLA (lithium gamma-linolenate acid) actively kills HIV-infected cells in the test tube. This study determined whether LiGLA is safe to administer to people with advanced HIV infection, and measured any short-term antiviral effects of the drug.
This was a Phase I study, which tests the drug on a very small group of people to see if it is safe. Volunteers were given daily doses of LiGLA through an intravenous tube, over 14 to 15 days. The dose of LiGLA was increased daily to see how much of the drug could be safely tolerated. Tests to assess the effect of the drug were taken regularly, including viral load, CD4 counts and other tests.
Twelve male and two female participants were enrolled in two study centres. The average age was 41; the median CD4 count at the start of the study was 35.
A significant decrease in hemaglobin (oxygen-carrying substance in red blood cells), accompanied by asymptomatic hematuria (passing blood in the urine) occurred in most patients. Side effects included gastrointestinal disturbance, fatigue and headache; however, no patients were discontinued from the study because of side effects. A transient (not lasting) decrease in viral load was noted in three participants mid-study.
Despite frequent side effects, LiGLA can be safely administered intravenously to people with advanced HIV infection. While a transient decrease in viral load was seen in several participants, the antiviral effect of LiGLA in people, as opposed to in the test tube, remains to be determined in a larger clinical trial.