Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
EC2008/06/PMG151/01
Study information
Scientific title
Tolerance, Physical and immunological response in Human Immunodeficiency Virus (HIV) seropositive persons supplemented daily with PMG151: Double blind, randomised controlled clinical trial
Acronym
PMG151
Study hypothesis
Daily supplementation with PMG151 in HIV seropositive persons has no side effects at long term and improve their physical conditions and immunological response.
Ethics approval
The local ethics committee (Comite d'Ethique pour la Recherche en Sante [CERS]) in Burkina Faso approved on the 1st of April 2009
Study design
Double blind randomised placebo controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet [In French]
Condition
AIDS/HIV
Intervention
Group 1: ART Treatment-experienced individuals: In this group 78 subjects will be treated with active form of PMG151 and 78 subjects with Placebo
Group 2: ART Treatment-naïve individuals: In this group 48 subjects will be treated with active form of PMG151 and 48 subjects with placebo.
Dose regimen: 2 capsules of PMG151/placebo (330mg each capsules) two times daily for 12 months. Capsules were taken orally with water.
The follow up period for each included participant is 12 months.
The study was a double blind study and assignment of study participant to take active form or placebo is randomised. The list of randomisation numbers was generated by a computer. Placebo used was maize starch.
Intervention type
Other
Phase
Phase IV
Drug names
Primary outcome measures
Tolerance, safety during supplementation period:
Medical examination for adverse event at each monthly visit, blood taken at baseline, 3, 6, 9 and 12 months for haematology (complete blood count [CBC]) and blood chemistry
Secondary outcome measures
Establish effects of supplementation on:
1. Nutritional status of patients (weight, brachial perimeter...)
2. Viral load
3. CD4 and CD8 counts
Overall trial start date
14/09/2009
Overall trial end date
04/04/2011
Reason abandoned
Eligibility
Participant inclusion criteria
1. HIV1 seropositive persons
2. Age between 18-55 years
3. Written informed consent given
4. Live in the study area for 12 next months
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
252 subjects planned: 156 treatment-experienced and 96 treatment-naïve individuals. Actually 156 treatment-experienced and 30 treatment-naïve (Recruitment closed)
Participant exclusion criteria
1. Pregnant and/or lactating females
2. HIV2 seropositive or HIV1 and HIV2 coinfection
3. High blood pressure (Hypertension)
4. Cardiac or renal disease
5. History of known sickle cell disease
6. Alcohol abuse
Recruitment start date
14/09/2009
Recruitment end date
04/04/2011
Locations
Countries of recruitment
Burkina Faso
Trial participating centre
University Hospital Yalgado Ouedraogo
Ouagadougou
03 POB 7022
Burkina Faso
Sponsor information
Organisation
Centre for Traditional Medicine and Integrated Care (Centre de Medecine Traditionelle et de Soins integrés [CMTSI]) (Burkina Fas
Sponsor details
General Directorate of Medicines Pharmacy and Laboratories
(Direction Generale de la Pharmacie du Medicament et des Laboratoires [DGPML])
Ouagadougou
03 POB 7009
Burkina Faso
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Centre for Traditional Medicine and Integrated Care (Centre de Medecine Traditionelle et de Soins integrés [CMTSI]) (Burkina Faso)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Ministry of Health (Burkina Faso) - General Directorate of Medicines Pharmacy and Laboratories (Direction Generale de la Pharmacie du Medicament et des Laboratoires [DGPML])
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary