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: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Missouri-Columbia
• Collaborators: National Center for Complementary and Integrative Health (NCCIH); Office of Dietary Supplements (ODS)

Criteria

Inclusion Criteria:

• Age 21 - 65 years

• HIV-1 infection documented by two different rapid tests for HIV-1 antibodies

• CD4 count >350 cells/ul

• Viral load< 20,000 copies/mL

• Normal hematological function

• Absence of clinically significant renal disease

• Normal liver function

• Random glucose < 11.1 mmol/L

• Normal electrocardiogram

• Regular attendance at the Wellness Clinic for at least 4 visits

• Cognitive capacity sufficient to provide informed consent

Exclusion Criteria:

• Any AIDS-defining diagnosis

• Weight loss > 5% of body weight within the preceding six months

• Other features of undiagnosed tuberculosis (including cough, fatigue, drenching night sweats and abnormal chest radiograph)

• Any other significant disease (active TB, hypertension, diabetes mellitus and other endocrine disorders, peptic ulcer disease, gastrointestinal malabsorption, psychiatric illness) either newly diagnosed or controlled by medication.

• Use of any allopathic or traditional medicine other than isoniazid for TB prophylaxis.

• Prior or current use of antiretroviral therapy

• History of allergic conditions or drug allergy/hypersensitivity

• Either history or family history of autoimmune disease

• Alcohol use of >7 units per week or >3 per session, tobacco use of more than 10 cigarettes per day or description of recreational drug use within the past 6 months.