Clinical trial NCT00549523: A Controlled Study of the Safety and Efficacy of Lessertia Frutescens in HIV-infected South African Adults
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: HIV Infections
Keywords: HIV
Alternative Medicine
Complementary Medicine
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
name: Office of Dietary Supplements (ODS)
First posted: 2007-10-26
Enrollment: 133
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: Primary: determine safety of L. frutescens when used by HIV-1 infected adults with early disease, and to document disease progression.
timeFrame: 24 week treatment period
Secondary outcomes:
measure: Secondary: Determine the effect of L. frutescens on quality of life in HIV-1 infected adults, and length of infection.
timeFrame: 24 week treatment period
Other outcomes:
Locations:
city: Pietermaritzburg
country: South Africa
facility: Department of Medicine, Edendale Hospital, Pvt Bag X 509
Study officials:
affiliation: University of Missouri-Columbia School of Medicine
name: William Folk, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Wilson 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.