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

Tolerance, Physical and immunological response in Human Immunodeficiency Virus (HIV) seropositive persons supplemented daily with PMG151: Double blind, randomised controlled clinical trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN22931534

Enrollment

186

Registered

2010-09-15

Start date

2009-09-14

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

AIDS/HIV Infections and Infestations Human immunodeficiency virus [HIV] disease

Interventions

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 grou

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Establish effects of supplementation on: 1. Nutritional status of patients (weight, brachial perimeter...) 2. Viral load 3. CD4 and CD8 counts	—

Countries

Burkina Faso

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026