Phase 4 HIV and AIDS Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged 18 to 64 years old
• People who weigh at least 110 pounds
• People with a Body Mass Index (BMI) between 18.5 and 40 (people with a BMI above 40 who are otherwise in good health may be considered with special approval)
• People willing to receive the Jynneos (MPOX) and Capvaxvie vaccines as part of the study
• People able to take tablets by mouth and willing to follow a metformin medication schedule
• People who have used injected opioids, amphetamines, and/or cocaine at any point in the past 10 years (based on self-report)
• People who have used non-prescription opioids, amphetamines, and/or cocaine within the past 30 days (based on self-report)
• People whose urine drug test has confirmed opioid, amphetamine, and/or cocaine use within the past 30 days
• People with a blood inflammation marker (CRP) above 3 mg/dL
• People with a non-fasting blood sugar level between 70 and 180 mg/dL
• People with a long-term blood sugar marker (HbA1c) between 5.0% and 6.4%, meaning blood sugar is normal or in the pre-diabetes range
• People with a CD4 immune cell count above 200 cells/ml
• People who are HIV-positive must have a very low HIV level in the blood (under 200 copies/ml) and must have been on HIV treatment for more than 12 months
• People willing and able to sign a consent form and commit to all study visits and procedures

Who may not be able to join:

• People who are unable to give informed consent
• People who are unwilling or unable to have blood drawn
• People diagnosed by a doctor with a bleeding or clotting disorder
• People who are pregnant or breastfeeding
• People who have been diagnosed with diabetes
• People with a history of serious kidney disease or whose kidney function test results fall below the required levels (confirm with trial site)
• People with a history of liver disease
• People whose liver function blood tests are significantly outside the normal range (confirm with trial site)
• People with certain other abnormal blood test results, including low protein levels, abnormal clotting, low red blood cell levels, low immune cell counts, or low platelet counts (confirm with trial site)
• People who screen positive for high-risk alcohol use based on a standard questionnaire score
• People with a history of acid build-up in the blood (metabolic acidosis) or relevant abnormal blood chemistry results (confirm with trial site)
• People with low vitamin B12 levels in the blood
• People with a history of ongoing or long-term diarrhea
• People currently taking metformin or any other diabetes medication
• People with a history of heart attack, stroke, heart failure, a serious heart infection (endocarditis), chronic lung disease, or blood poisoning (sepsis)
• People currently taking or who have taken certain medications within the past 30 days, including furosemide, nifedipine, ranolazine, vandetanib, or cimetidine
• People with an active hepatitis B infection
• People with a hepatitis C infection within the past 6 months, or who completed hepatitis C treatment less than 6 months ago
• People who have received the Jynneos or a pneumococcal vaccine within the past two years (based on self-report)
• People with a known severe allergic reaction to metformin, the Jynneos vaccine, or the Capvaxvie vaccine
• People who have donated more than 450 mL of blood in the 8 weeks before joining the study
• People whose overall health, mental health, or personal circumstances the study doctor believes could interfere with study procedures

Important: Always verify eligibility with the trial site directly before applying.