Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201401000720267 Date of Approval: 04/12/2013
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Project goal is eliminate HIV within all systems of the body and to prevent its transmission.
Official scientific title Randomized, Double Blind, Placebo-Controlled Trial of an Advanced Fused Silver Water formula in HIV-1 infected, Tuberculosis and Malaria in the Kingdom of Lesotho and Republic of South Africa.
Brief summary describing the background and objectives of the trial Acquired Human Immunodeficiency Syndrome (AIDS) is a disease which targets and depletes the body¿s T helper cells. It is caused by the Human Immunodeficiency Virus type 1 (HIV_1). Viral load, as measured in Peripheral Blood Mononuclear Cells (PBMCs) cultures, have been shown to correlate with early disease progression and loss of CD4 cells. Similarly suppression of viral replication by an antiretroviral agent in Vitro is a clear indication that such an agent, could be a potential candidate for treatment of HIV_1 infection. A broad spectrum anti-viral agent that really works is needed to combat immune system diseases. This includes some of the most formidable viral organisms like HIV (including co-infections), Tuberculosis, and Malaria. In these experiment 200 patients in Lesotho and South Africa, PHA-stimulated PBLs infected with HIV_1 JRCSF will be treated with Silver water formula agent.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) UPCOSH Lesotho Trial
Disease(s) or condition(s) being studied Infections and Infestations,upper respiratory tract infections
Sub-Disease(s) or condition(s) being studied HIV/AIDS,Malaria,Tuberculosis
Purpose of the trial Treatment: Drugs
Anticipated trial start date 18/03/2015
Actual trial start date 17/04/2014
Anticipated date of last follow up 17/03/2015
Actual Last follow-up date 17/03/2016
Anticipated target sample size (number of participants) 200
Actual target sample size (number of participants) 100
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
To be issued and communicated here Ministry of Health Lesotho
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Cluster randomized trial with randomization using restricted randomization Numbered containers Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group UPCOSH Oxy-Silver Liquid Per os dosage ranges from one teaspoon to one tablespoon taken on an empty stomach Every 20 to 60 minutes during initial stages (first week) of acute URTI, reducing dosages accordingly with symptom alleviation. UPCOSH Protocol 22
Control Group Placebo Per os dosage ranges from one teaspoon to one tablespoon taken on an empty stomach Every 20 to 60 minutes during initial stages (first week) of acute URTI, reducing dosages accordingly with symptom alleviation. This trial will be the first study investigating the Oligodynamic Ag+¿s antimicrobial efficacy well beyond its virotoxicity and it's compelling nature and ability to successfully eradicate pervasive primary and secondary co-infections simultaneously 100 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All early acute patients aged 9 years and above with chronic infection; HIV/AIDS, malaria, tuberculosis, will be invited to participate in this study. All early acute patients are included as they will be considered critical for the study. Pregnant women or participants who were found to be pregnant during the study will be excluded from the study. 9 Year(s) 70 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 04/02/2014 National Health Research Ethics Committee Lesotho
Ethics Committee Address
Street address City Postal code Country
Research Coordination Unit, Corner of Constitution and Linare Road Maseru 00100 Lesotho
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Proportion of all TB patients who are infectious with HIV (HIV infected and viral load >1000 copies/ml. Baseline 21 months
Primary Outcome Proportion of all TB patients who are infectious with HIV (HIV infected and viral load >1000 copies/ml. Baseline 21 months
Primary Outcome Proportion of all TB patients who are infectious with HIV (HIV infected and viral load >1000 copies/ml. Baseline 21 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tuberculosis Control Programme Block D Level 8 Development House Maseru 00100 Lesotho
FUNDING SOURCES
Name of source Street address City Postal code Country
FDT Holding Ltd 7904 E. Chaparral Road., Bldg. A110 Unit #490, Scottsdale, Arizona 85250 Phoenix 85001 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Health Gateway (PTY) Ltd Main North 1, Mapeleng Machahe Area Maseru 00100 Lesotho Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
Rajani Shrestha 3 College of Medicine, Chosun University 375, South Korea Seoul 8000 Korea, Republic of
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ssemakula Peter Luyima peter.luyima@gahcltd.com +26657754830 Main North 1, Mapeleng Macheche Area
City Postal code Country Position/Affiliation
Maseru 00100 Lesotho Project Oveerser/Researcher
Role Name Email Phone Street address
Public Enquiries Ricardo A.Frazer rfrazer@atlm.edu +1404-756-4707 Atlanta Metropolitan State College, 1630 Metropolitan Parkway, SW. Atlanta, GA. 30310
City Postal code Country Position/Affiliation
Georgia 30310 United States of America Public Health Authority
Role Name Email Phone Street address
Scientific Enquiries Leonard George Horowitz len15@mac.com 208-265-8065 5348 Vegas Drive, Suite 353
City Postal code Country Position/Affiliation
Las Vegas, NV 89108 United States of America 923-9936-4787
Role Name Email Phone Street address
Scientific Enquiries Kent Holtorf gordonmd@sonic.net 310-375-2705 23441 Madison St.#215, Torrance, CA 90505
City Postal code Country Position/Affiliation
Carlifornia 90505 United States of America Medical Director/ clinical experience using picoscalar oligodynamic silver hydrosol
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information