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

NCT00549523 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 133

Last updated 2016-10-10

No results posted yet for this study

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.

Conditions

  • HIV Infections

Interventions

DRUG

Placebo

Capsules containing 0 mg bid (placebo)

DRUG

Low Dose

Capsules containing 400 mg bid of L. frutescens.

DRUG

Mid Dose

Capsules containing 800 mg bid of L. frutescens.

DRUG

High Dose

Capsules containing 1200 mg bid of L. frutescens.

Sponsors & Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

    collaborator NIH

  • Office of Dietary Supplements (ODS)

    collaborator NIH

  • University of Missouri-Columbia

    lead OTHER

Principal Investigators

  • William Folk, Ph.D. · University of Missouri-Columbia School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2012-01-31
Completion
2012-01-31

Countries

  • South Africa

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00549523 on ClinicalTrials.gov