A Controlled Study of the Safety and Efficacy of Lessertia Frutescens in HIV-infected South African Adults
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
2 other identifiers
interventional
133
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 hiv-infections
Started Apr 2008
Longer than P75 for phase_1 hiv-infections
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 24, 2007
CompletedFirst Posted
Study publicly available on registry
October 26, 2007
CompletedStudy Start
First participant enrolled
April 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedOctober 10, 2016
October 1, 2016
3.8 years
October 24, 2007
October 7, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Primary: determine safety of L. frutescens when used by HIV-1 infected adults with early disease, and to document disease progression.
24 week treatment period
Secondary Outcomes (1)
Secondary: Determine the effect of L. frutescens on quality of life in HIV-1 infected adults, and length of infection.
24 week treatment period
Study Arms (4)
Placebo
PLACEBO COMPARATORPlacebo (capsule filled with inert materials)
Low Dose
EXPERIMENTAL400 mg bid Lessertia Frutescens
Mid Dose
EXPERIMENTAL800 mg bid Lessertia Frutescens
High Dose
EXPERIMENTAL1200 bid Lessertia Frutescens
Interventions
Capsules containing 400 mg bid of L. frutescens.
Capsules containing 800 mg bid of L. frutescens.
Capsules containing 1200 mg bid of L. frutescens.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Medicine, Edendale Hospital, Pvt Bag X 509
Pietermaritzburg, 3216, South Africa
Related Publications (2)
Johnson Q, Syce J, Nell H, Rudeen K, Folk WR. A randomized, double-blind, placebo-controlled trial of Lessertia frutescens in healthy adults. PLoS Clin Trials. 2007 Apr 27;2(4):e16. doi: 10.1371/journal.pctr.0020016.
PMID: 17476314BACKGROUNDWilson D, Goggin K, Williams K, Gerkovich MM, Gqaleni N, Syce J, Bartman P, Johnson Q, Folk WR. Consumption of Sutherlandia frutescens by HIV-Seropositive South African Adults: An Adaptive Double-Blind Randomized Placebo Controlled Trial. PLoS One. 2015 Jul 17;10(7):e0128522. doi: 10.1371/journal.pone.0128522. eCollection 2015.
PMID: 26186450DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
William Folk, Ph.D.
University of Missouri-Columbia School of Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 24, 2007
First Posted
October 26, 2007
Study Start
April 1, 2008
Primary Completion
January 1, 2012
Study Completion
January 1, 2012
Last Updated
October 10, 2016
Record last verified: 2016-10
Data Sharing
- IPD Sharing
- Will not share