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Biguanide

Metformin for HIV/AIDS

Phase 2 & 3
Waitlist Available
Led By Cecilia M Shikuma, MD
Research Sponsored by University of Hawaii
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up entry to week 72
Awards & highlights

Study Summary

This trial is testing if the diabetes medication metformin can improve the health of people with HIV who are taking antiretroviral therapy (ART).

Eligible Conditions
  • HIV/AIDS

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~entry to week 72
This trial's timeline: 3 weeks for screening, Varies for treatment, and entry to week 72 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
CD4 T cell PD1+TIGIT+
Secondary outcome measures
CD8 T cell PD1+TIGIT+
Peripheral blood CD4 T cell intracellular HIV DNA
Peripheral blood CD4 T cell intracellular HIV RNA
+3 more
Other outcome measures
Beck's Depression Index II score
Carotid intima-media thickness
Handgrip
+3 more

Side effects data

From 2015 Phase 4 trial • 156 Patients • NCT02002221
13%
Nasopharyngitis
10%
Hyperhidrosis
9%
Hunger
9%
Tremor
8%
Asthenia
6%
Hypoglycaemia
1%
Squamous cell carcinoma of the tongue
1%
Femoral neck fracture
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vildagliptin (LAF237)
Placebo

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: MetforminExperimental Treatment1 Intervention
Metformin 500 mg Extended Release (ER) qd increasing to 1000 mg ER qd at week 4 and continued to week 48.
Group II: ObservationActive Control1 Intervention
Observed without metformin
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Metformin
FDA approved

Find a Location

Who is running the clinical trial?

University of HawaiiLead Sponsor
115 Previous Clinical Trials
54,651 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,896 Previous Clinical Trials
5,062,680 Total Patients Enrolled
Cecilia M Shikuma, MDPrincipal InvestigatorUniversity of Hawaii
2 Previous Clinical Trials
36 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the most common reason that Metformin is prescribed?

"Metformin is a medication with many uses, one of which is treating type 1 diabetes mellitus. It can also be used to treat other conditions such as diabetic ketoacidosis and polycystic ovary syndrome."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Impact of Metformin on Immuno-virologic Parameters in HIV
Cecilia Shikuma 2019. "Impact of Metformin on Immuno-virologic Parameters in HIV". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04500678.
~6 spots leftby May 2025
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