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:
2025-12-24 @ 1:17 PM
Ignite Modification Date:
2025-12-24 @ 1:17 PM
NCT ID:
NCT02071095
Eligibility Criteria:
Inclusion Criteria:
* HIV-1 infection documented by previous HIV-1 serology or rapid test, or documented plasma HIV-1 RNA of \>2000 copies/ml
* On stable cART regimen in accordance with the DHHS "Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents" with documented virologic suppression (VL\<50 copies/ml) for ≥ 48 weeks.
* Baseline cell associated HIV-1 RNA is detectable (≥10copies/µg RNA)
* Laboratory values obtained within 30 days prior to study entry.
* VL \< 50 copies/ml
* CD4+ T cell count \> 500 cells/mm3
* Absolute neutrophil count (ANC) ≥500/mm3
* Hemoglobin ≥9.0 g/dL if female; 10 g/dL if male
* Platelet count ≥75,000/mm3
* AST (SGOT), ALT (SGPT) ≤3.5 × ULN
* Alkaline phosphatase\< 2.5 ULN
* Total bilirubin ≤2.5 x ULN
* Lipase ≤2.5 x ULN
* Calculated creatinine clearance ≥70 mL/min as estimated by the Cockcroft-Gault equation:
* For men(140-age in yrs)x(body wt in kg)÷(serum creatinine in mg/dLx72)=CrCl (mL/min)\*
\*For women, multiply the result by 0.85 = CrCl (mL/min)
* NOTE: A program to assist in calculations is available on the DMC web site at: http://www.fstrf.org/ACTG/ccc.html
* For women of reproductive potential, negative serum or urine pregnancy test
* Female candidates of reproductive potential is defined as girls who have reached menarche or women who have not been post-menopausal for at least 24 consecutive months (i.e., who have had menses within the preceding 24 months) or have not undergone surgical sterilization (e.g., hysterectomy, or bilateral oophorectomy, or bilateral tubal ligation).
* Contraception requirements
* Female candidates of reproductive potential, who are participating in sexual activity that could lead to pregnancy, must agree that they will use at least two reliable barrier methods of contraception while receiving the protocol-specified treatments and for at least 24 weeks after completing stage I of the study.
* Men and women aged 18-55 years.
* Ability and willingness of subject to give written informed consent.
* Adequate venous access for phlebotomy
Exclusion Criteria:
* Previous immune based therapy
* History of vascular disease including h/o coronary artery disease, angina/MI, TIA/CVA, peripheral vascular disease/claudication
* Strong family history of cardiovascular disease
* Hyperlipidemia requiring medication
* Diabetes
* History of Tobacco use (≥10 pack years)
* HIV-related nephropathy
* History of vascular disease including history of coronary artery disease, angina/MI, TIA/CVA, peripheral vascular disease/claudication, poorly controlled hypertension
* Pregnancy or currently breast-feeding
* Desire to become pregnant during the course of study
* Use of immunomodulators (e.g., interleukins, interferons, cyclosporine), systemic cytotoxic chemotherapy, or investigational therapy within 30 days prior to study entry.
* Known allergy/sensitivity to study drugs or their formulations.
* Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
* History of autoimmunity
* Chronic Hepatitis B (HepBSAg+) or C (HCV RNA positive)
* Current imprisonment or involuntary incarceration in a medical facility for psychiatric or physical (e.g., infectious disease) illness.
* Participation in any other clinical trial within 30 days prior to screening.
* Receipt of routine vaccination(s) within 7 days of study entry, or anticipated receipt of routine vaccination(s) during the first 4 weeks of the study. If routine vaccinations are to be administered following the first 4 weeks of the study, they cannot be administered within 7 days prior to weeks 16 and 48 follow up visits.
* Multi-drug resistant (MDR) HIV-1 precluding standard 3-drug therapy
* Any other clinical conditions or prior therapy that, in the opinion of the investigator, would make the subject unsuitable for the study or unable to comply with the requirements.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT02071095
Study Brief:
Protocol Section:
NCT02071095