Efficacy and safety of daily supplementation with PMG151 in individuals living with Human Immunodeficiency Virus (HIV)

ISRCTN ISRCTN22931534
DOI https://doi.org/10.1186/ISRCTN22931534
Secondary identifying numbers EC2008/06/PMG151/01
Submission date
20/08/2010
Registration date
15/09/2010
Last edited
14/12/2010
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Youssouf Joseph Drabo
Scientific

University Hospital Yalgado Ouedraogo
Ouagadougou
03 POB 7022
Burkina Faso

Study information

Study designDouble blind randomised placebo controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet [In French]
Scientific titleTolerance, Physical and immunological response in Human Immunodeficiency Virus (HIV) seropositive persons supplemented daily with PMG151: Double blind, randomised controlled clinical trial
Study acronymPMG151
Study objectivesDaily supplementation with PMG151 in HIV seropositive persons has no side effects at long term and improve their physical conditions and immunological response.
Ethics approval(s)The local ethics committee (Comite d'Ethique pour la Recherche en Sante [CERS]) in Burkina Faso approved on the 1st of April 2009
Health condition(s) or problem(s) studiedAIDS/HIV
InterventionGroup 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 typeOther
Primary outcome measureTolerance, 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 measuresEstablish effects of supplementation on:
1. Nutritional status of patients (weight, brachial perimeter...)
2. Viral load
3. CD4 and CD8 counts
Overall study start date14/09/2009
Completion date04/04/2011

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit55 Years
SexBoth
Target number of participants252 subjects planned: 156 treatment-experienced and 96 treatment-naïve individuals. Actually 156 treatment-experienced and 30 treatment-naïve (Recruitment closed)
Key inclusion criteria1. HIV1 seropositive persons
2. Age between 18-55 years
3. Written informed consent given
4. Live in the study area for 12 next months
Key exclusion criteria1. 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
Date of first enrolment14/09/2009
Date of final enrolment04/04/2011

Locations

Countries of recruitment

  • Burkina Faso

Study participating centre

University Hospital Yalgado Ouedraogo
Ouagadougou
03 POB 7022
Burkina Faso

Sponsor information

Centre for Traditional Medicine and Integrated Care (Centre de Medecine Traditionelle et de Soins integrés [CMTSI]) (Burkina Fas
Hospital/treatment centre

General Directorate of Medicines Pharmacy and Laboratories
(Direction Generale de la Pharmacie du Medicament et des Laboratoires [DGPML])
Ouagadougou
03 POB 7009
Burkina Faso

Website http://www.dgpml.sante.gov.bf

Funders

Funder type

Hospital/treatment centre

Centre for Traditional Medicine and Integrated Care (Centre de Medecine Traditionelle et de Soins integrés [CMTSI]) (Burkina Faso)

No information available

Ministry of Health (Burkina Faso) - General Directorate of Medicines Pharmacy and Laboratories (Direction Generale de la Pharmacie du Medicament et des Laboratoires [DGPML])

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan