HE-2000, an adrenal steroid which could be administered orally as a pulsed immune booster, has shown promising effects in its first clinical trial in HIV-positive people.
Manufacturers Hollis-Eden Pharmaceuticals tested HE-2000 in 36 treatment-naïve patients in South Africa. Participants had baseline CD4 counts between 200 and 500, and viral load above 5,000 copies. The study was a dose-escalating trial, with 12 individuals commencing at a dose of 50mg, and equal numbers commencing at doses of 20mg and 50mg once the safety of the lower dose had been tested.
Participants received 1 dose, followed by a 7 day observation period, and then received five further daily doses before a 28 day observation period. A handful of patients have completed a further five day dosing cycle.
The median CD4 increase was similar at all doses, with an increase of 70 cells after 37 days (p=0.007). The median viral load decline after 49 days was modest, at 0.45 log (p=0.001). However, some individuals with more lengthy exposure to HE-2000 had stronger responses that were augmented after each cycle, in a similar fashion to pulsed dosing of interleukin-2.
Further trials of HE-2000 are planned, and it is hoped that the drug will be administered by dissolving on the tongue or gums in future studies, rather than by intramuscular injections. Researchers will also try to establish the optimum frequency for dosing HE-2000, and how it might improve responses to HAART.
Reference
Gray CM et al. The immunological effect of HE-2000 in drug-naïve HIV-1 infected patients. Thirteenth International AIDS Conference, Durban, abstract TuPeB3194, 2000.