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
Scientific
University Hospital Yalgado Ouedraogo
Ouagadougou
03 POB 7022
Burkina Faso
Study information
| Study design | Double blind randomised placebo controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet [In French] |
| Scientific title | Tolerance, Physical and immunological response in Human Immunodeficiency Virus (HIV) seropositive persons supplemented daily with PMG151: Double blind, randomised controlled clinical trial |
| Study acronym | PMG151 |
| Study objectives | 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(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) studied | 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 |
| Primary outcome measure | 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 study start date | 14/09/2009 |
| Completion date | 04/04/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 55 Years |
| Sex | 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) |
| Key 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 |
| Key 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 |
| Date of first enrolment | 14/09/2009 |
| Date of final enrolment | 04/04/2011 |
Locations
Countries of recruitment
- Burkina Faso
Study participating centre
University Hospital Yalgado Ouedraogo
Ouagadougou
03 POB 7022
Burkina Faso
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
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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
