A Controlled Study of the Safety and Efficacy of Lessertia Frutescens in HIV-infected South African Adults
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Other: Sutherlandia |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver) Primary Purpose: Supportive Care |
| 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 |
- Primary: determine safety of L. frutescens when used by HIV-1 infected adults with early disease, and to document disease progression. [ Time Frame: 24 week treatment period ] [ Designated as safety issue: Yes ]
- Secondary: Determine the effect of L. frutescens on quality of life in HIV-1 infected adults, and length of infection. [ Time Frame: 24 week treatment period ] [ Designated as safety issue: Yes ]
| Enrollment: | 133 |
| Study Start Date: | April 2008 |
| Study Completion Date: | January 2012 |
| Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: 1
Placebo (capsule filled with inert materials)
|
Other: Sutherlandia
Capsules containing 0 mg bid (placebo), 400 mg bid, 800 mg bid, or 1200 mg bid of L. frutescens.
Other Names:
|
|
Experimental: 2
400 mg bid
|
Other: Sutherlandia
Capsules containing 0 mg bid (placebo), 400 mg bid, 800 mg bid, or 1200 mg bid of L. frutescens.
Other Names:
|
|
Experimental: 3
800 mg bid
|
Other: Sutherlandia
Capsules containing 0 mg bid (placebo), 400 mg bid, 800 mg bid, or 1200 mg bid of L. frutescens.
Other Names:
|
|
Experimental: 4
1200 bid
|
Other: Sutherlandia
Capsules containing 0 mg bid (placebo), 400 mg bid, 800 mg bid, or 1200 mg bid of L. frutescens.
Other Names:
|
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| Ages Eligible for Study: | 21 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| South Africa | |
| Department of Medicine, Edendale Hospital, Pvt Bag X 509 | |
| Pietermaritzburg, South Africa, 3216 | |
| Principal Investigator: | William Folk, Ph.D. | University of Missouri-Columbia School of Medicine |
More Information
Additional Information:
Publications:
| Responsible Party: | William Folk, Professor of Biochemistry, University of Missouri-Columbia |
| ClinicalTrials.gov Identifier: | NCT00549523 History of Changes |
| Other Study ID Numbers: | U19 AT003264-01, U19AT003264-01, TICIPS002_RP01 (E295/05) |
| Study First Received: | October 24, 2007 |
| Last Updated: | January 3, 2013 |
| Health Authority: | United States: Federal Government United States: Institutional Review Board South Africa: University of KwaZulu-Natal Institutional Review Board South Africa: Medicines Control Council |
Keywords provided by University of Missouri-Columbia:
|
HIV Alternative Medicine Complementary Medicine |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
ClinicalTrials.gov processed this record on May 16, 2013