Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2025-12-25 @ 1:41 AM
NCT ID:
NCT01552694
Eligibility Criteria:
Inclusion Criteria:
* 18-65 yr old HIV infected men and women.
* Stable (at least the past 6 months) on combined antiretroviral therapy (cART).
* Stable immune (\> 300 CD4+ T-cells/µL) and virologic (\< 50 copies HIV RNA/mL) status.
* Insulin resistant/impaired glucose tolerance (fasting glucose 100-125mg/dL, or 2-hr glucose 140-200mg/dL or fasting HOMA-IR= 2.5-6.0).
* Waist circumference \> 102 cm (men), \> 88 cm (women).
* BMI \> 20 kg/m2.
* Fasting hypertriglyceridemia \> 150 mg/dL.
* Low HDL-cholesterol (\< 40 mg/dL in men or \< 50 mg/dL in women).
* Platelet count \> 30,000/mm3.
* Absolute neutrophil count \> 750/mm3.
* Transaminases \< 2.5x the upper limit of normal.
* Long-term non-progressors (not taking anti-HIV medications) are not eligible.
Exclusion Criteria:
* Diabetes (T2DM, IDDM or diabetic ketoacidosis) or taking any glucose-lowering medication (e.g., insulin, TZDs, metformin, sulfonylurea).
* Any agent that might artifactually alter glycemic control (e.g., glucocorticoids, megace, rhGH, GH-secretagogue, testosterone derivatives, creatine monohydrate, chromium picolinate, AA/protein supplements, medium- or long-chain fatty acids) during 6 months prior to or during enrollment.
* History of serious CV disease. NYHA Functional Class III or IV (e.g., recent MI, unstable angina, edema, CHF, CAD, CABG, stroke, resting hypertension \> 160/95 mmHg), irregular heart rhythm, resting ST-segment depression \> 1mm). Treatment with medications for CV condition (e.g., α- or ß-blockers). Some BP-lowering medications (Ca++channel blocker, diuretic, or ACE inhibitor) are permitted.
* Moderate to severe renal insufficiency. Serum creatinine \> 1.7 mg/dL (men) \> 1.5 mg/dL (women).
* Plan or anticipate a change in anti-HIV medications during the study.
* Lipid-lowering medications are permitted (fibrate or statin or niacin), but must be stable on that agent for at least 6 months prior to enrollment. Lipid-lowering agents cannot be started during the treatment period.
* Chronic hepatitis B (HBV-surface antigen positive). Active hepatitis C (detectable Hep C RNA).
* Positive urine drug test for opiates, methamphetamine, heroin, cocaine. Active substance abuse that the MD-scientist believes may compromise safety, compliance, interfere with study drug or data interpretation.
* Hematocrit \< 34% in men or \< 25% in women with symptoms (fatigue, "tired-legs", shortness of breath). Hemoglobin \< 10 gm/dL with symptoms.
* Pregnant or nursing mothers. Women must agree to use an acceptable form of birth control during the study. If using birth control pills-must be stable on this medication for at least 6 months prior to enrollment.
* Active malignancy or treatment with chemotherapeutic agents or radiation therapy or any cytokine or anti-cytokine therapy during 6 months prior to enrollment.
* History of pancreatitis
* \> 10% unintentional weight loss during the 6 months prior to enrollment.
* Reduced cognitive function/unable to provide voluntary informed consent. Prisoners are excluded.
* Blinded investigational drugs for 3 months prior to enrollment that will not be unblinded before enrollment.
* Nausea, vomiting, diarrhea (\> 4 loose stools/day) that are unresponsive to treatment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01552694
Study Brief:
Protocol Section:
NCT01552694