HIV Infections Clinical Trial
Official title:
A Randomized, Double-blind, Placebo-Controlled Study of the Safety and Efficacy of Lessertia Frutescens (L.)Goldblatt and J.C. Manning (Syn. Sutherlandia Frutescens (L.)R. Br.)in HIV-infected South African Adults
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.
The study is a 2-stage, double-blind, randomized, placebo-controlled study following a
two-stage, statistical selection theory design. Fifty-six HIV positive subjects will be
randomized onto Stage 1 that will comprise a 4-arm parallel group (one placebo and 3
treatment groups) trial. One or possibly two interim analyses will be performed to determine
continuation to Stage 2. A blinded interim analysis to determine the superior active
treatment arm of Stage 1 will be continued to Stage 2 after 8 subjects per arm have
completed the 24-week dosing regimen and the interim analysis. The study will be terminated
if the interim analysis identifies either significant safety issues, or demonstrable
non-significance. Following a significant outcome in the blinded interim analysis, the
selected active and placebo control arms will continue blinded until total n=48 participants
per arm for the placebo and selected treatment group have completed 24 weeks per arm.
Respective groups will receive capsules containing L. frutescens in dosages of 0 (placebo
material), 400mg bid, 800 mg bid or 1200 mg bid in the first stage. Progression to stage 2
will utilize a two arm design in which 34 subjects will receive either 0 mg L. frutescens
(placebo) or the active dosage of L. frutescens bid for 24 weeks.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Supportive Care
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