Condition category
Infections and Infestations
Date applied
20/08/2010
Date assigned
15/09/2010
Last edited
14/12/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Youssouf Joseph Drabo

ORCID ID

Contact details

University Hospital Yalgado Ouedraogo
Ouagadougou
03 POB 7022
Burkina Faso

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

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

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

Publication citations

Additional files

Editorial Notes