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SF2000SD Clinical Trial in Zambia (SF2000SD)

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ClinicalTrials.gov Identifier: NCT02941159
Recruitment Status : Unknown
Verified November 2017 by Tropical Diseases Research Centre, Zambia.
Recruitment status was:  Recruiting
First Posted : October 21, 2016
Last Update Posted : November 17, 2017
Sponsor:
Collaborators:
National Institute for Scientific and Industrial Research
University of Zambia
National AIDS/TB/STIs Council of Zambia
Copperbelt University of Zambia
Dr Ludwick Sondashi Formular Clinic
Information provided by (Responsible Party):
Tropical Diseases Research Centre, Zambia

Brief Summary:
The purpose of this study is to assess the safety and tolerability of SF2000SD in adult male healthy volunteers

Condition or disease Intervention/treatment Phase
Good Health Biological: SF2000SD Biological: Placebo Phase 1

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: A Phase I Single Blind, Randomized, Placebo Controlled, Parallel Group Study to Investigate the Safety and Tolerability of SF2000SD in Healthy Male Volunteers
Study Start Date : September 2016
Actual Primary Completion Date : November 2017
Estimated Study Completion Date : February 2018

Arm Intervention/treatment
Active Comparator: SF2000SD
The test product is a Sondashi Formula Spray dried extract (SF2000SD). It is derived from spray drying with water the Sondashi Formula (SF2000), which is a mixture of mixture of 4 plants. SF2000SD is packaged into capsules of 500mg and six capsules are taken twice, daily for 42 days. This drug has anti-HIV properties but in this study we are just looking at safety issues.
Biological: SF2000SD
This is an intergrase inhibitor

Placebo Comparator: Placebo
The placebo arm is composed of capsule containing 500mg of inactive ingredient (Microcrystalline Cellulose PH102 -240mg; Starch - 10mg; Magnesium Stearate -10mg; and Maltodextrin Unidry 20 - 240mg).
Biological: Placebo



Primary Outcome Measures :
  1. Proportion of study participants with clinical adverse events such as diarrhea, vomiting, changes in vital signs etc. associated with the test product [ Time Frame: 56 days ]
  2. Proportion of study participants with changes in laboratory liver and renal values after administration of test product. These will include ALT, AST, ALP, Total biluribin, Glucose, Urea and Creatinine [ Time Frame: 56 days ]
  3. Proportion of study participants with changes in blood hematological values after administration of test product. This will involve Full Blood Count (FBC) including differential for white blood cells [ Time Frame: 56 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

To be eligible to participate in study, the participant should be;

  1. Male aged 18 to 45 years.
  2. Available in Ndola during the 10 weeks study duration.
  3. Able to provide proof of residence.
  4. Able to complete Consent Form
  5. In good health as determined by the combination of medical history, physical examination, and clinical judgment and laboratory results following TDRC normal ranges. Urine dipstick for protein and blood should be negative or trace. If either is ≥1+, complete urinalysis will be obtained (UA). If microscopic UA confirms hematuria or proteinuria ≥ 1+, the volunteer is ineligible.
  6. Serologically negative for HIV, HBV and HCV infection.

Exclusion Criteria:

Anyone who meets ANY of the following exclusion criteria will NOT qualify for enrolment into the study.

  1. Female
  2. A history related to TB
  3. Any of the following chronic illnesses: diabetes, asthma, hypertension, skin conditions.
  4. On herbal medicine and/ or traditional medicines or immune boosting treatments
  5. Received an investigational drug or herbal medicine not less than 2 months by the time of administration of the study dose
  6. excessive alcohol consumption/alcohol abuse
  7. Smokes
  8. HIV and/or HBV and/or HCV positive

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02941159


Contacts
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Contact: Modest Mulenga, MD; PhD +260-212-620737 mulengam@tdrc.org.zm
Contact: Shepherd Khondowe, MPH +260-212-620737 khondowes@tdrc.org.zm

Locations
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Zambia
Tropical Diseases Resaerch Centre Recruiting
Ndola, Copperbelt, Zambia, 71769
Contact: Modest Mulenga, MD; PhD    +260-212-620737    mulengam@tdrc.org.zm   
Contact: Shepherd Khondowe, MPH    +260-212-620737    khondowes@tdrc.org.zm   
Principal Investigator: Ray Handema, PhD         
Sub-Investigator: Alasford Ngwengwe, PhD         
Sub-Investigator: Victor Mwanakasale, MD; PhD         
Sponsors and Collaborators
Tropical Diseases Research Centre, Zambia
National Institute for Scientific and Industrial Research
University of Zambia
National AIDS/TB/STIs Council of Zambia
Copperbelt University of Zambia
Dr Ludwick Sondashi Formular Clinic
Investigators
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Principal Investigator: Ray Handema, PhD Tropical Diseases Research Centre

Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
Data documents can be requested from at info@tdrc.org.zm using the above given website contact page

Publications:
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Responsible Party: Tropical Diseases Research Centre, Zambia
ClinicalTrials.gov Identifier: NCT02941159     History of Changes
Other Study ID Numbers: SF2000SDPh1
First Posted: October 21, 2016    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes