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A Controlled Study of the Safety and Efficacy of Lessertia Frutescens in HIV-infected South African Adults

2014-08-27 03:35:28 | BioPortfolio

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.

Description

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.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Supportive Care

Conditions

HIV Infections

Intervention

Sutherlandia

Location

Department of Medicine, Edendale Hospital, Pvt Bag X 509
Pietermaritzburg
South Africa
3216

Status

Recruiting

Source

University of Missouri-Columbia

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:35:28-0400

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