A Controlled Study of the Safety and Efficacy of Lessertia Frutescens in HIV-infected South African Adults
Status:
Completed
Trial end date:
2012-01-01
Target enrollment:
Participant gender:
Summary
The study is a 2-stage, double-blind, randomized, placebo-controlled study in which fifty-six
HIV-positive subjects will be randomized into the first stage. Interim analysis to determine
continuation to stage 2 will be performed to determine continuation after 8 subjects per arm
have completed a 24-week dosing regimen.
Primary objectives are to determine the safety of Lessertia frutescens when used by HIV-1
infected adults with early disease, and to document the impact of Lessertia frutescens on
markers of HIV disease progression. Secondary objective is to determine the effect of
Lessertia frutescens on quality of life in HIV-infected adults and length of infection.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
University of Missouri-Columbia
Collaborators:
National Center for Complementary and Integrative Health (NCCIH) Office of Dietary Supplements (ODS)