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HIV InfectionsPhase 1/2NCT00549523

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

A Phase 1/2 study testing Low Dose, Mid Dose and High Dose in people with HIV Infections, run by University of Missouri-Columbia at 1 site in South Africa.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 21 to 65 years
Conditions the study is for
HIV Infections
What is being tested?
Low Dose, Mid Dose and High Dose
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
133 participants
Where
1 siteSouth Africa
Study dates
Apr 2008to Jan 2012
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

South Africa1 site

  • Department of Medicine, Edendale Hospital, Pvt Bag X 509

    Pietermaritzburg, 3216

Other trials in South Africa

About this study

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

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.

Read the 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.

Conditions
HIV Infections
Being tested
Placebo, Low Dose, Mid Dose, High Dose
Keywords
HIV, Alternative Medicine, Complementary Medicine
Medical subject headings
HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

    Capsules containing 0 mg bid (placebo)

  • Low DoseDrug

    Also called Lessertia Frutescens, Sutherlandia

    Capsules containing 400 mg bid of L. frutescens.

  • Mid DoseDrug

    Also called Lessertia Frutescens, Sutherlandia

    Capsules containing 800 mg bid of L. frutescens.

  • High DoseDrug

    Also called Lessertia Frutescens, Sutherlandia

    Capsules containing 1200 mg bid of L. frutescens.

Study groups in NCT00549523
Study groupRoleWhat they receive
PlaceboPlacebo comparatorPlacebo (capsule filled with inert materials)
Receives: Drug: Placebo
Low DoseExperimental400 mg bid Lessertia Frutescens
Receives: Drug: Low Dose
Mid DoseExperimental800 mg bid Lessertia Frutescens
Receives: Drug: Mid Dose
High DoseExperimental1200 bid Lessertia Frutescens
Receives: Drug: High Dose

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary: determine safety of L. frutescens when used by HIV-1 infected adults with early disease, and to document disease progression.

    Measured: 24 week treatment period

Secondary outcomes (1)

  1. Secondary: Determine the effect of L. frutescens on quality of life in HIV-1 infected adults, and length of infection.

    Measured: 24 week treatment period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2007 (estimated)
  2. Study startApr 2008
  3. Primary completionJan 2012
  4. Study completionJan 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
133 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00549523
Sponsor's protocol ID
U19AT003264-01
Other IDs
U19AT003264-01, TICIPS002_RP01 (E295/05)
Status last verified
Oct 2016
First submitted
24 Oct 2007
Last updated
10 Oct 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 17476314

  • 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.

    PubMed 26186450

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Low Dose, Mid Dose and High Dose in people with HIV Infections, run by University of Missouri-Columbia at 1 site in South Africa.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00549523, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2016.

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