Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE4
40 participants
INTERVENTIONAL
2018-12-15
2020-01-08
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
To this end, in the present study, patients with prediabetes (who meet the fasting impaired glucose criteria) will be identified and treated with metformin or placebo for 8 weeks, receiving stable TARA and with a CD4 + level\> 200 cells / μL.
40 patients from the HIV Unit of the Civil Hospital of Guadalajara "Fray Antonio Alcalde" will be included in this study and the intervention will last 8 weeks.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Metformin Experimental Arm
Metformin 850mg/12 hours, oral, 8 weeks
Metformin Hydrochloride 850 MG
8 weeks tratment with oral metformin
Placebo Comparator Arm
Placebo pills/12hours, oral, 8 weeks
Placebo
8 weeks tratment with oral placebo
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Metformin Hydrochloride 850 MG
8 weeks tratment with oral metformin
Placebo
8 weeks tratment with oral placebo
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Age ≥18 years of age
* With a diagnosis of HIV-1 infection,
* That they are receiving TARE for at least 12 months (time necessary to establish a stable reservoir),
* Patients with undetectable viral load (\<40 copies / mL) for at least 12 months,
* Have a CD4 + level\> 200 cells / μL,
* That they do not have a diagnosis of co-infection with HCV or HBV,
* Patients who do not have a severe alcohol intake (\<21 glasses / week in men and \<14 glasses / week in women),
* Patients who do not use drugs during the last 90 days prior to the screening visit, or during the study,
* Who wish to participate voluntarily in the study and give their written consent.
Exclusion Criteria
* Patients with contraindications to the use of metformin \*.
* Individuals who are actively involved in an experimental therapy study or who have received experimental therapy in the last 6 months.
* People suffering from stage IV-V chronic kidney disease, uncontrolled heart failure or active infections.
* Individuals with diabetes mellitus (according to the criteria of the American Diabetes Association \*).
* Patients with indication for the use of statins, aspirin or immunomodulators.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hospital Civil de Guadalajara
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Moises Ramos Solano
Associate professor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hospital Civil de Guadalajara
Guadalajara, Jalisco, Mexico
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Slim J, Saling CF. A Review of Management of Inflammation in the HIV Population. Biomed Res Int. 2016;2016:3420638. doi: 10.1155/2016/3420638. Epub 2016 Sep 27.
Arafath S, Campbell T, Yusuff J, Sharma R. Prevalence of and Risk Factors for Prediabetes in Patients Infected With HIV. Diabetes Spectr. 2018 May;31(2):139-143. doi: 10.2337/ds17-0009.
Nou E, Lo J, Grinspoon SK. Inflammation, immune activation, and cardiovascular disease in HIV. AIDS. 2016 Jun 19;30(10):1495-509. doi: 10.1097/QAD.0000000000001109.
Saisho Y. Metformin and Inflammation: Its Potential Beyond Glucose-lowering Effect. Endocr Metab Immune Disord Drug Targets. 2015;15(3):196-205. doi: 10.2174/1871530315666150316124019.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
114/18
Identifier Type: -
Identifier Source: org_study_id