Clinical Trials Logo

Clinical Trial Summary

Anti-HIV drugs cut down the number of serious infections that people with HIV get. However, some subjects taking anti-HIV drugs do not achieve adequate cluster of differentiation 4 (CD4) recovery and decrease in elevated cluster of differentiation 8 (CD8) cells. Such patients with a low CD4/CD8 ratio remain at risk for developing acquired immune deficiency syndrome (AIDS) and non-AIDS-related complications. Two of the most important factors associated with low CD4/CD8 ratio include: the persistence of HIV on ART and inflammation. Metformin, the most widely used medication to treat type 2 diabetes, is well tolerated with minimal side effects. It has been linked to anti-aging and weight reducing properties in non-diabetic persons. Because of its ability to improve immune functions, metformin could be a promising addition to ART in HIV patients. It is also reported to change the composition of microbes in the gut which may improve inflammation. PURPOSES OF THE STUDY The purposes of this study are to find out if: 1. metformin can be combined with anti-HIV drugs to reduce the amount of hidden virus in the body; 2. metformin can be combined with anti-HIV drugs to improve immune function. 3. metformin can be combined with anti-HIV drugs to impact CD4 T cell count and CD4/CD8 T cell ratio during treatment and after its discontinuation 4. metformin can change the composition of the bacteria in the gut which may improve inflammation. For this purpose, the investigators will add metformin at the usual antidiabetic dose for 12 weeks for patients receiving stable ART, having a CD4/CD8 ratio below 0.7. Approximately 22 participants will be enrolled in this study at the Chronic Viral Illness Service of the McGill University Health Centre, the Ottawa Hospital and the Maple Leaf Medical Clinic (Toronto). This study will last about 24 weeks; metformin treatment will be for 12 weeks. In order to be eligible for the study, the participants must be 18 years of age or older, have an undetectable viral load (the quantity of the HIV virus in the blood must be less than 50 copies/ml) for at least 3 months and have a CD4/CD8 ratio of less than 0.7. All participants will also be asked to give blood and stool samples and optional colon mucosal biopsy samples (before and after metformin supplementation) to study the size of the viral reservoir and the amount of T cell activation and changes in gut microbiota composition.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT02659306
Study type Interventional
Source McGill University Health Centre/Research Institute of the McGill University Health Centre
Contact
Status Completed
Phase Phase 1
Start date September 2016
Completion date February 2020

See also
  Status Clinical Trial Phase
Active, not recruiting NCT02135419 - Treatment in Preventing Anal Cancer in Patients With HIV and Anal High-Grade Lesions Phase 3
Active, not recruiting NCT02663856 - My Smart Age With HIV: Smartphone Self-assessment of Frailty
Completed NCT02846402 - Impact of HIV Self-testing Among Female Sex Workers in Kampala, Uganda N/A
Completed NCT02663869 - Aging With HIV at Younger vs Older Age: a Diverse Population With Distinct Comorbidity Profiles
Terminated NCT02743598 - Liraglutide for HIV-associated Neurocognitive Disorder Phase 4
Completed NCT02921516 - Growing Up: Intervening With HIV-Positive Adolescents in Resource-Poor Settings N/A
Completed NCT02564341 - Targeting Effective Analgesia in Clinics for HIV - Intervention N/A
Active, not recruiting NCT02302950 - A Retrospective Analysis of Raltegravir Use in Minority HIV Infected Women in Houston, Texas N/A
Terminated NCT02109224 - Ibrutinib in Treating Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma in Patients With HIV Infection Phase 1
Completed NCT01830595 - Lactoferrin Treatment in HIV Patients Phase 2
Completed NCT02269605 - Bryostatin-1 Effect on HIV-1 Latency and Reservoir in HIV-1 Infected Patients Receiving Antiretroviral Treatment Phase 1
Terminated NCT01902186 - Bone Mineral Density Changes in HIV-positive Females With Osteopenia Switching to Raltegravir Phase 4
Completed NCT01852942 - Reversing Tissue Fibrosis to Improve Immune Reconstitution in HIV Phase 2
Completed NCT01946217 - Factors Affecting Patient Participation in AIDS Malignancy Clinical Trials Consortium Clinical Trials N/A
Completed NCT02118168 - Observational Study for the Extended Follow-up of the Patients Enrolled in the Therapeutic Clinical Trial ISS T-002 N/A
Completed NCT02527135 - Text Messaging to Improve HIV Testing Among Young Women in Kenya N/A
Completed NCT02525146 - Birmingham Access to Care Study N/A
Active, not recruiting NCT02602418 - Neural Correlates of Working Memory Training for HIV Patients N/A
Completed NCT01680094 - Safety and Effect of The HDAC Inhibitor Panobinostat on HIV-1 Expression in Patients on Suppressive HAART Phase 1/Phase 2
Completed NCT01702974 - Immune Reconstitution in HIV Disease (IREHIV) Phase 2